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Pottery Barn Fabric Samples: Great store, and even better — free fabric. After brief screening, 94CSOs were randomly allocated to an immediate intervention condition II or a wait list condition WL that received the CRAFT intervention after 3 months.

Results: At 3-month f-u, II revealed significant higher ADI engagement rates CSOs in both groups reported significant improvements in terms of mental health and family cohesion after having received the intervention, i.

II at 3-months f-u and WL at 6-month f-u. Community Reinforcement and Family Training CRAFT is an intervention designed to help the concerned significant others CSOs of people with alcohol problems who are reluctant to seek treatment. The aim of the present pragmatic cluster-randomized trial was to compare the effectiveness of three formats for delivering CRAFT in real life settings: group sessions, individual sessions, and written material only control group.

Eighteen public treatment centers for alcohol use disorders were randomly assigned to deliver CRAFT in one of the three formats as part of their daily clinical routine.

CSOs were recruited via pamphlets, general practitioners, and advertisements on social media. Trained clinicians delivered CRAFT in individual and group format, and self-administered CRAFT was limited to handing out a self-help book. The primary outcome was treatment engagement of the IP after three months.

A total of CSOs were found to be eligible and randomly assigned to receive CRAFT delivered in group, individual, or self-administered format. We hypothesized that CSOs receiving CRAFT in a group format would improve the most, but although our findings pointed in this direction, the differences were not statistically significant.

Clinical trials. gov ID: NCT Peer Review reports. Alcohol use disorder AUD causes serious consequences for the persons who suffer from the condition, but lately there has been an increased focus on those who have a close relationship with the drinker, the so-called concerned significant others CSOs.

The CSOs often live in stressful circumstances and have lots of worries that frequently lead to poorer physical and mental health [ 1 ] as well as lower quality of life [ 2 ] compared to the general population.

Moreover, this group of CSOs often experience loneliness and stigmatization [ 3 ]. In Denmark, , people are assumed to suffer from alcohol dependence [ 4 ]; however, only around 17, Danes are enrolled in specialized treatment each year [ 5 ]. Moreover, it is often the case that the person with AUD has been suffering from the disorder for 10 years or more before entering treatment [ 6 ].

As a result, both persons with AUD and their CSOs may, at length, suffer from the consequences of alcohol use. Interventions for CSOs, independent from treatment for the individual with the substance use disorder i.

To date, the approach with the best evidence is Community Reinforcement and Family Training CRAFT , a behavioral intervention that aside from improving the well-being of CSOs, teaches them how to change their behavior in order to positively influence the IP to seek treatment.

Also, the IP treatment engagement rates varied according to the type of format used to deliver CRAFT to the CSOs. In studies where the CSOs were offered individual therapy, Group format is considered a cost-effective way of providing CRAFT, and a study by Manuel and colleagues indicated that CRAFT delivered in closed group format may be just as effective as individual CRAFT, but the sample size was indeed small and the study did not compare the two formats directly [ 8 ].

Whether CRAFT delivered in open group format is as effective as individual CRAFT has yet to be investigated. Open and closed groups have different advantages and disadvantages. Closed group formats are often preferred since they allow the same group of participants to meet and get to know one another well and to go through a logical chain of topics from start to finish.

However, closed group formats often involve waiting lists, since it is not possible for new participants to join the intervention until a new group starts. In contrast, an open group format allows for new participants to join an existing group and blend in with the other participants.

The order of the topics in the open group is similar to that of closed formats, but, consequently, this means that some new group members may, so to speak, start in what may be considered to be the middle of a chain of topics and continue until they reach the middle of the chain again.

We expect to find higher improvement in the quality of life of the CSOs receiving group CRAFT than those receiving individual CRAFT, since the CSOs in group CRAFT may benefit from the dynamics that occur in a group of individuals sharing, at least in part, similar circumstances.

Moreover, being part of a group may create a sense of mutual recognition and may lower the feeling of isolation and shame among CSOs [ 9 ]. Although CRAFT is one of the most studied methods aimed at helping CSOs to motivate IPs to enter treatment for AUD, only very few studies have tested CRAFT in a European context [ 10 , 11 , 12 ].

Most previous studies have tested the impact of CRAFT on IP treatment entry rates and only few studies have reported other measures such as improvement in the mental health of CSOs and impact on family cohesion [ 10 , 12 ]. In sum, the most studied format for delivering CRAFT is individual counseling, and only a few studies have analyzed CRAFT delivered in group format.

There is some evidence that CRAFT based on self-help materials leads to elevated rates of IP treatment entry. Most studies, so far, took place in a research-based environment [ 8 , 12 ].

So, although there are several high-quality randomized control trials, the effectiveness of different CRAFT-formats under regular treatment conditions is still unclear. The present study was thus designed as a pragmatic trial operating within real-life conditions.

The study followed the implementation of CRAFT interventions into the daily routine of Danish community-based alcohol treatment centers, and the therapists involved were staff from the alcohol treatment centers participating in the study. The aim of the present study was to investigate whether one of the three formats for delivering CRAFT individual, open group, self-administered is more effective than the others in getting problem drinkers to seek treatment for their alcohol problems, and whether one format has a larger impact on the quality of life of the CSOs than the others.

When planning the study, we hypothesized that:. CSOs randomly assigned to receive six sessions of CRAFT delivered in either individual format or group format with a continuous enrollment of CSOs would be able to motivate their IP to enter treatment significantly more often than CSOs randomly assigned to a control condition consisting of self-administered CRAFT.

Six sessions of CRAFT delivered in open group format with continuous enrollment of CSOs would improve the quality of life and psychological functioning of the CSOs significantly more than both individual and self-administered CRAFT.

The present study is not only the first to examine group CRAFT in Europe, but it is also the first to investigate CRAFT delivered in an open group format [ 9 ]. The 18 treatment centers comprised both larger institutions with more than 25 staff members and small centers with fewer staff members.

The treatment centers were randomized to deliver CRAFT to the CSOs in one of the following three formats:. CRAFT as six open group sessions, supported by written material.

The groups started when two CSOs had contacted the treatment facility and continuously included new members. Each CSO followed six group sessions with one or two therapists. Control condition, consisting of CRAFT delivered in a self-administered format and by means of written material only.

Thus, each facility was assigned to deliver CRAFT in one of the three formats to all CSOs who approached the facility for support during the study period.

Due to low capacity, it was assumed that the small centers could not recruit enough CSOs to run a group within a reasonable time frame. Therefore, we chose to perform a cluster randomization in three stages.

The three large centers were the first to be randomized to deliver CRAFT in one of the three formats, followed by the smallest centers, and then the remaining medium-sized centers.

The randomization was performed in the computer program STATA, by giving the participating treatment centers random numbers and then randomly assigning them to one of the three conditions. The randomizations were blinded and performed by an independent person not involved in the study.

The CSOs were not told beforehand which intervention each facility had been allocated to. The participating centers were spread out over Denmark. Consecutive CSOs who contacted a center that had been randomized to deliver either individual or group CRAFT were offered the particular intervention within two weeks of an intake interview.

Both individual and group CRAFT consisted of six sessions with 7—10 days between each session [ 9 ]. CSOs in all three groups began with an intake interview where they were interviewed, asked about potential violence and threats from the drinkers, and filled out the baseline questionnaire. In the case of risk of violence being present, the CSO was given advice on how to receive specific help.

Consecutive CSOs who contacted a center that had been randomized to deliver self-administered CRAFT were offered an intake interview and, afterwards, written material only. At the intake interview, the CSOs were informed that they could have an individual follow-up session with a therapist after three months for additional support, if needed.

This individual follow-up session was offered after the primary outcome had been measured and it was added to ensure that the CSOs in the control group felt that they had received adequate help. Treatment as usual was disregarded since the usual interventions being offered to the CSOs differ between the treatment centers.

Some centers offer brief advice over the phone, while other centers offer group-based psychoeducation or individual personal support delivered face to face. Instead, we decided to offer the control group written material with the possibility of a follow-up face-to-face session with a therapist after three months and regarded this to be an appropriate minimal intervention.

To disseminate the information on CRAFT interventions being available to the public and the possibility of CSOs needing to seek it, information leaflets and posters were distributed by the participating local authorities.

The local authorities were committed to distributing the leaflets via social services departments, departments for children and adolescents, and general practitioners and others who might come into contact with CSOs.

CRAFT was introduced as being of help to the significant other, but the type of delivery format used by the local alcohol treatment institutions was not described.

The leaflet also provided information on where to receive a CRAFT intervention, i. CSOs were excluded if they 1 suffered from dementia or other cognitive disorders; 2 did not speak Danish; 3 were psychotic or otherwise severely mentally ill; 4 had been receiving treatment for alcohol problems for the past three months; and 5 were concerned about a person who, according to the CSO, mainly used illegal substances.

All CSOs who sought help through one of the participating treatment centers and fulfilled the criteria were offered the CRAFT format that the facility had been randomized to.

No other interventions aimed at helping CSOs were offered at the participating treatment centers during the study period.

After enrollment and before the first session, the CSOs completed a self-administered questionnaire baseline, t0 on a tablet, starting with an informed consent form.

Data were collected again after three months t1 and six months t2 by a self-administered Web-based battery of questionnaires or by telephone interview. The participants received up to three reminders for the follow-up questionnaire until they had responded.

Data on whether and when IPs started treatment were collected from the CSOs three and six months after enrollment of the CSOs into the study. Response options for each question were coded 0—4 and summed. The primary outcome was the proportion of IPs who entered alcohol treatment between baseline and three months after enrollment of their CSO to the study.

If there was a missing response at both 3 and 6 months the variable was missing. To assess changes in the quality of life of the CSOs following the CRAFT intervention, we used the four subscales of the World Health Organization Quality of Life instrument WHOQOL : Physical Health, Psychological, Social Relationships, and Environment.

All four subscales are scored from 1 to 5, with a higher score indicating a higher level of quality of life [ 16 ]. The recruitment of the CSOs and the interventions were conducted between January 1 st , , and December 31 st , The therapists taking part in the study were regular employees at the treatment centers and comprised social workers, nurses, and psychologists, most of them with special training in Motivational Interviewing and all of them experienced in working with patients with AUD and their relatives.

The therapists who delivered individual or group CRAFT underwent a three-day course in CRAFT before delivering the intervention.

The therapists delivering the control intervention were not trained until after conclusion of the study period to avoid spill-over effects. The training was undertaken by one of the authors GB in charge of a German study of CRAFT during the years — [ 12 ]. The training consisted of an examination of all the elements in CRAFT, including practicing and role-play.

In addition, the therapists received brush-up training after six months. The therapists were guided by a treatment protocol and each session was documented.

The treatment sessions followed a protocol, based on the CRAFT manual [ 18 ], and all sessions were audio recorded in preparation to ensure treatment adherence and supervision of the therapists.

To ensure fidelity to the CRAFT method and therapist style, two authors ASN and MH listened to a randomly drawn sample of the audiotapes recorded during treatment sessions. Feedback was given to the therapists, as well as feedback on additional specific sessions, if the therapist asked for this.

The therapists received feedback on a minimum of two recordings of their sessions if they delivered individual CRAFT or co-performed in a facility randomized to deliver group CRAFT.

Only three therapists asked for feedback on a specific session. The project group met with key therapists from each treatment center each month during the first year of the project and every second month during the last year of the project.

Here, a current status of the project was given, cases were discussed, and additional supervision was given. Previous CRAFT studies conducted with the CSOs of persons with AUD mostly offered 12—14 sessions of CRAFT to the CSOs [ 7 ]. In the present study, the number of sessions for individual CRAFT was reduced to six sessions of one hour, and for group CRAFT the number of sessions was reduced to six two-hour sessions.

The reason for this was two-fold: partly because if the interventions prove successful, an intervention consisting of six sessions is assumed to have a fair chance to be implemented in the daily routine of clinical practice in a Danish context, free of charge for the CSOs; and partly because the findings of previous CRAFT studies suggest that IP treatment engagement is typically realized within the first six sessions [ 19 ].

CSOs randomized to the control condition only received written material and were considered to be controls for the first three months after enrollment. The book described the eight topics covered in CRAFT including violence. In addition, the book included a chapter containing basic information about the mechanisms in AUDs, and how AUD affects both IPs and CSOs, as well as information about alcohol treatment, what treatment implies, and how to easily get access to treatment.

All three groups received the book: the control-group received the book as the only intervention, and participants in the individual and group conditions received the book as an additional support to the face-to-face interventions. In Denmark, treatment for AUD does not require a referral and it is free of charge to all citizens.

By law, treatment has to be offered within two weeks, and individuals may choose to seek treatment at their local treatment center or at a treatment center in another municipality if they prefer.

In contrast to previous studies, no special treatment for the IPs was integrated within the CRAFT interventions in the present study. However, if an IP became motivated to seek treatment, free treatment was immediately made available at the treatment center where the CSO had received the CRAFT intervention, or in any other community-based treatment center.

The CSOs were thoroughly informed about treatment options for IPs, e. Data were analyzed using Stata version The primary outcome was compared between the three CRAFT groups at three- and six-months follow-up using logistic regression.

To check for imbalance in the baseline values between the three randomized groups, we used analysis of variance ANOVA [ 23 ]. A combined group was created comprising the CSOs who received individual or group CRAFT, and the primary outcome was compared between this combined group and the self-help CRAFT group at both follow-up times.

Corresponding analyses were conducted on a combination of the primary outcome at three- and six-months follow-up: IPs who were engaged in treatment at either three- or six-months follow-up were compared to IPs who were not engaged in therapy at any time.

Secondary outcomes were compared between the three CRAFT groups at three- and six-months follow-up, using linear regression with robust standard errors and analysis of covariance, adjusting for baseline values of the outcomes, with robust standard errors.

Further, another combined group was created comprising the CSOs who received individual or self-help CRAFT, and the secondary variables were compared between this combined group and the group that received CRAFT in group format.

The three- and six-months analyses were based on Intention-to-treat. The analyses were checked by a third person. Effects of CRAFT were tested one-sided since previous studies consistently demonstrated improvement in all outcome measures in individuals receiving CRAFT [ 18 ].

This study was approved by the Danish Data Protection Agency Region of Southern Denmark — project no. The study was submitted for ethical approval to the Danish Ethics Committee Project-ID: S but we were informed that the study did not require formal approval since it was a questionnaire survey to compare different ways of implementing a recommended treatment method, CRAFT, according to the National Clinical Guidelines in Denmark.

All participants were informed, both orally and in writing, about the procedures for attending the study.

The participants signed an informed consent document prior to participating in the study. All relevant guidelines have been followed according to the Declaration of Helsinki. During the study period from — , a total of CSOs see Fig.

A dropout analysis see supplementary table 2 was made for those who did not complete the three- or six- months follow-up.

The analysis showed that the ones who did not answer at three- or six-months follow-up were younger and scored lower on the Quality-of-Life domain environment DOM4 at baseline.

Baseline characteristics of the CSOs and IPs are presented in Table 1. The WHOQol-score at baseline was highest for the domain Physical Health DOM1 , with an average score of The score for the domain Psychological DOM2 was The domain Social Relationships DOM3 was The average PHQ-9 depression score for all participants was 8.

The score was highest for participants in the group CRAFT intervention 8. Table 2 shows the percentage of IPs who had entered treatment three months following the enrollment of their CSO to the study.

The change in the WHOQol-score among the CSOs from baseline to three months follow-up is presented in Table 3. The CSOs who received group CRAFT reported an increase in the WHOQol-score from baseline to three months follow-up in all four quality of life domains except for the environment domain The CSOs who received individual CRAFT reported an increase in scores in all four domains.

The CSOs in the control group reported an increase in scores in the physical health domain DOM1 0. There were no significant differences between the group intervention vs. The change in the PHQ-9 depression score from baseline to three months follow-up is also presented in Table 3.

All three groups showed a decrease in the depression score at three months follow-up, with a mean change for all CSOs at The decrease was highest among the CSOs who received group CRAFT It is the first study to investigate three formats for delivering CRAFT in the same study, one being the format of open groups, as well as the first study to be performed as an effectiveness trial in real-life settings and with a relatively low number of exclusion criteria.

While the results favored the group and individual formats over the self-help format after both three- and six-months follow-up, the difference between the groups was not statistically significant. Although treatment initiation of IPs typically occurs within the first three months after enrollment of the CSO in a CRAFT intervention, additional IPs enroll in treatment during the period 3—6 months after enrollment of the CSO [ 12 , 25 ].

After six months, there only seems to be a very small increase in treatment engagement rate from 6 to 12 months [ 12 , 19 ]. In the present study, we did not find a significant difference in the IP treatment engagement rate between the interventions.

In contrast to the present study, Manuel and colleagues investigated the impact of a closed group format [ 8 ]. Since closed group formats without continuous enrollment of new group members tend to imply waiting lists for the new participants, we investigated the impact of an open group format with continuous enrollment of new CSOs.

The outcome of such open groups, measured as treatment engagement rate of the IP, did not differ significantly from individual sessions, but we learned that it was manageable to deliver CRAFT in such a format.

One explanation for the lower treatment engagement rate for both group and individual CRAFT in the present study compared to prior studies might be because we reduced the number of CRAFT sessions to six instead of the 10—14 sessions offered in previous studies [ 8 , 12 , 19 , 27 , 28 ], and that the CSOs, therefore, did not have the time needed to train, for instance, communication skills.

In the study on iCRAFT, i. The reasons for investigating the impact of a lower number of CRAFT sessions were several. First, we considered it more manageable for the CSOs to join a shortened intervention.

Second, we considered it easier and more likely, in the long run, to implement a shorter CRAFT format in the public treatment institutions, compared to an intervention consisting of twice as many sessions.

Moreover, a previous study indicated that the treatment engagement for the IP already took place after 4—6 CRAFT sessions with the CSO [ 19 ], and we therefore considered that six sessions might be a reasonable treatment intervention.

The Canadian Remote Access Framework for clinical Trials (CRAFT) represents a Tissue Bank ,+ samples from + trials · Network + The sample size of the entire trial varies according to the performance of the individual study arms, ranging between 98 and patients UKCRC Registered Clinical Trials Unit. Design, conduct & analysis; helps to deliver health & social care research across SW Wales & beyond, in academia

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One route to address these health disparities is to employ evidence-based treatments (EBTs). EBTs are rarely tested with sufficiently large samples of racial The sample size of the entire trial varies according to the performance of the individual study arms, ranging between 98 and patients Create documents, which will make an impact. Try Craft for free both for personal and business/teams use cases: Craft sample trials





















Crart, researchers may Crxft to perform batch analyses sam;le stored Econo-food promotions, not just for logistical convenience but also Free sunscreen samples Wallet-friendly food discounts variability—particularly when samples are collected Value-conscious meal offers from the same subjects. Federal Government. Full size image. How Translational Central Lab Services Facilitate Creative Solutions for Biomarker-Driven Studies. Volunteers No Healthy Volunteers. There is no consensus definition on a CSO in the literature, but it could, for example, be a spouse, a daughter, a son, a cousin, a friend or a colleague. Age at least 18 years the CSO Reports that IP is not currently in addiction treatment at IrisZorg and elsewhere and has not received addiction treatment in the past 3 months Reports that IP is treatment-refusing Evidence according CSO that the IP meets criteria for SUDs according to The Structured Clinical Interview for DSM IV axis 1 Disorders SCID-I Exclusion Criteria: Does not demonstrate an adequate understanding of their participation, informed consent, and requirements of the protocol, or has insufficient reading abilities to comprehend the Dutch self-help book or does not agree to participate by refusing to sign an informed consent CSO meets the DSM-IV criteria for any current SUD diagnosis, through clinical assessment by The Structured Clinical Interview for DSM IV axis 1 Disorders SCID-I and the Dutch version of the Mini- International Neuropsychiatric Interview M. Furthermore, an open group format may create opportunities for senior members in the group to share experiences and advice with newcomers [ 20 ]. All authors have been involved in revising the draft critically and have read and approved the final manuscript. Chapter Google Scholar Kroenke K, Spitzer RL, Williams JB. The study will be carried out by the Unit of Clinical Alcohol Research UCAR , The Clinical Research Institute, and The University of Southern Denmark. The Canadian Remote Access Framework for clinical Trials (CRAFT) represents a Tissue Bank ,+ samples from + trials · Network + The sample size of the entire trial varies according to the performance of the individual study arms, ranging between 98 and patients UKCRC Registered Clinical Trials Unit. Design, conduct & analysis; helps to deliver health & social care research across SW Wales & beyond, in academia Another great way to get free craft samples is to sign up for free trials and doing surveys. Of course, you either need to pay after the Jurors need clear instructions to guide their deliberations. Crafting good instructions will help you win at trial and on appeal. JURY INSTRUCTIONS can make a Patient samples have always been critical assets for clinical trial success. In this era of precision medicine, sample management has become Within this seven-arm basket phase II clinical trial, we aim to investigate the efficacy of targeted-therapy plus immune checkpoint inhibition in patients with To date, the approach with the best evidence is Community Reinforcement and Family Training (CRAFT), a behavioral intervention that aside from Continuous ReAssessment with Flexible ExTension in Rare Malignancies (CRAFT) is an open-label phase II trial for adults with pretreated, locally Craft sample trials
In Craaft, 61 institutions were tials to participate, and 17 institutions Wallet-friendly food discounts to smple in the Value-conscious meal offers. CSOs in both groups reported significant improvements in terms of mental health and family cohesion after having received Value-conscious meal offers intervention, i. Adv Ther. Epub Trialls One explanation for Affordable and convenient dining lower treatment engagement rate for both group and individual CRAFT in the present study compared to prior studies might be because we reduced the number of CRAFT sessions to six instead of the 10—14 sessions offered in previous studies [ 812192728 ], and that the CSOs, therefore, did not have the time needed to train, for instance, communication skills. Combining online Community Reinforcement and Family Training CRAFT with a parent-training programme for parents with partners suffering from alcohol use disorder: study protocol for a randomised controlled trial. Nationales Centrum für Tumorerkrankungen NCT Recruiting Heidelberg, Germany, Contact: Richard F. Administration of a live, attenuated vaccine within 4 weeks before initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study Patients with clinical suspicion of active tuberculosis Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug Is taking or requiring the continued use of any of the prohibited concomitant medications listed in the trial protocol Any concurrent antineoplastic therapy. This is the classic website, which will be retired eventually. To assess changes in the quality of life of the CSOs following the CRAFT intervention, we used the four subscales of the World Health Organization Quality of Life instrument WHOQOL : Physical Health, Psychological, Social Relationships, and Environment. Article CAS Google Scholar Nielsen AS. An analysis of the CSOs, lost-to-follow-up at three- and six months follow-up, showed that those who were lost to follow-up were significantly younger than those who were not. The sample size of the entire trial varies according to the performance of the individual study arms, ranging between 98 and patients. The Canadian Remote Access Framework for clinical Trials (CRAFT) represents a Tissue Bank ,+ samples from + trials · Network + The sample size of the entire trial varies according to the performance of the individual study arms, ranging between 98 and patients UKCRC Registered Clinical Trials Unit. Design, conduct & analysis; helps to deliver health & social care research across SW Wales & beyond, in academia SAMPLES - HOW TO ORDER. Order your free samples quickly and easily - look for the 'Add Sample' button on product pages or under the 'Add to Cart' button on Missing I draw inspiration from looking at my failures, material samples, experimenting with new ways of crafting: I think by doing. I could be inspired The Canadian Remote Access Framework for clinical Trials (CRAFT) represents a Tissue Bank ,+ samples from + trials · Network + The sample size of the entire trial varies according to the performance of the individual study arms, ranging between 98 and patients UKCRC Registered Clinical Trials Unit. Design, conduct & analysis; helps to deliver health & social care research across SW Wales & beyond, in academia Craft sample trials
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Global status Craft sample trials on alcohol and health. Community Reinforcement trialls Family Training CRAFT is aimed triaos CSOs who struggle Free product samples available, in an Crafft to motivate their loved ones to stop drinking and seek treatment. Community reinforcement and family training: a pilot comparison of group and self-directed delivery. GB: responsible for training of therapists. Samples products are free but there is a small charge for delivery unless included with an order. Article Google Scholar Sisson RW, Azrin NH. SHIPPING TO: SHOPPING IN:. The study will be carried out by the Unit of Clinical Alcohol Research UCAR , The Clinical Research Institute, and The University of Southern Denmark. The CSOs signed the informed consent document to participate in the study. Data on whether and when IPs started treatment were collected from the CSOs three and six months after enrollment of the CSOs into the study. Drug Alcohol Rev. The Canadian Remote Access Framework for clinical Trials (CRAFT) represents a Tissue Bank ,+ samples from + trials · Network + The sample size of the entire trial varies according to the performance of the individual study arms, ranging between 98 and patients UKCRC Registered Clinical Trials Unit. Design, conduct & analysis; helps to deliver health & social care research across SW Wales & beyond, in academia So far, eight randomized or controlled clinical trials on CRAFT have Several of these studies have rather small samples from 12 to 40 PDF | Canada's vast geography, and centralized delivery of cancer care and clinical trials create barriers for trial participation for patients in The Canadian Remote Access Framework for clinical Trials (CRAFT) represents a Tissue Bank ,+ samples from + trials · Network + Missing To date, only two randomized controlled trials (RCTs) of CRAFT study analyses the efficacy of CRAFT in a sample of CSOs outside of the U.S So far, eight randomized or controlled clinical trials on CRAFT have Several of these studies have rather small samples from 12 to 40 Craft sample trials
CRAFT: The NCT-PMO-1602 Phase II Trial

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Saral Paper: Free Wax Transfer Paper is a great start to MANY different craft ideas. Ecos Paints: Need a small amount of paint for a craft project? Click here to get free craft samples of paint. For the first time, this study analyses the efficacy of CRAFT in a sample of CSOs outside of the U.

Methods: Participants were recruited through the treatment system general practitioners, psychotherapists, addiction counselling services and through media solicitation. After brief screening, 94CSOs were randomly allocated to an immediate intervention condition II or a wait list condition WL that received the CRAFT intervention after 3 months.

Results: At 3-month f-u, II revealed significant higher ADI engagement rates Well-being, health and illness among adults in the Region of Southern Denmark ]. Article CAS Google Scholar.

Loneck B, Garrett JA, Banks SM. The Johnson intervention and relapse during outpatient treatment. Drug Alcohol Abuse. Miller WR, Meyers RJ, Tonigan JS. Engaging the unmotivated in treatment for alcohol problems: a comparison of three strategies for intervention through family members.

J Consult Clin Psychol. Copello A, Templeton L, Orford J, Velleman R. The 5-Step Method: Evidence of gains for affected family members. Drugs: Education, Prevention and Policy. Kirby KC, Benishek LA, Kerwin ME, Dugosh KL, Carpenedo CM, Bresani E, et al.

Analyzing components of community reinforcement and family training CRAFT : is treatment entry training sufficient? Psychol Addict Behav. Sisson RW, Azrin NH. Family-member involvement to initiate and promote treatment of problem drinkers.

J Behav Ther Exp Psychiatry. Manuel JK, Austin JL, Miller WR, McCrady BS, Tonigan JS, Meyers RJ, et al. Community reinforcement and family training: a pilot comparison of group and self-directed delivery. Meyers RJV, M.

Smith J. The Community Reinforcement Approach: History and New Directions. Journal of Cognitive Psychotherapy: An International Quarterly. Kirby KC, Marlowe DB, Festinger DS, Garvey KA, La MV.

Community reinforcement training for family and significant others of drug abusers: a unilateral intervention to increase treatment entry of drug users.

Drug Alcohol Depend. Meyers RJ, Miller WR, Smith JE, Tonigan JS. A randomized trial of two methods for engaging treatment-refusing drug users through concerned significant others.

Brigham GS, Slesnick N, Winhusen TM, Lewis DF, Guo X, Somoza E. A randomized pilot clinical trial to evaluate the efficacy of community reinforcement and family training for treatment retention CRAFT-T for improving outcomes for patients completing opioid detoxification. Bischof G, Iwen J, Freyer-Adam J, Rumpf HJ.

Efficacy of the community reinforcement and family training for concerned significant others of treatment-refusing individuals with alcohol dependence: a randomized controlled trial. Roozen HG, de Waart R, van der Kroft P. Community reinforcement and family training: an effective option to engage treatment-resistant substance-abusing individuals in treatment.

Addiction Abingdon, England. Lindner P, Siljeholm O, Johansson M, Forster M, Andreasson S, Hammarberg A. Combining online Community Reinforcement and Family Training CRAFT with a parent-training programme for parents with partners suffering from alcohol use disorder: study protocol for a randomised controlled trial.

BMJ Open. Magnusson K, Nilsson A, Hellner Gumpert C, Andersson G, Carlbring P. Internet-delivered cognitive-behavioural therapy for concerned significant others of people with problem gambling: study protocol for a randomised wait-list controlled trial. Dutcher LW, Anderson R, Moore M, Luna-Anderson C, Meyers RJ, Delaney HD, et al.

Community reinforcement and family training CRAFT : an effectiveness study. Journal of Behavior Analysis in Health, Sports, Fitness and Medicine. Redko C, Rapp RC, Carlson RG.

Waiting time as a barrier to treatment entry: perceptions of substance users. J Drug Issues. Nielsen AS. Selvhjælpsbog til pårørende til mennesker med alkoholproblemer- Hjælp til at få din pårørende i behandling- og hjælp til dig selv, så du får større glæde i dit liv.

Meyers RJ WB. Get your loved one sober. Alternatives to nagging, pleading, and threatening. Hazelden Center City, Minnesota Meyers RJ, Smith JE. Strategien zur Selbsthilfe für Angehörige von Menschen mit Alkoholproblemen.

Der Community Reinforcement Ansatz das Familien-Training CRAFT : [Self-help strategies for relatives of people with alcohol problems. The Community Reinforcement Approach to Family Training CRAFT ]Lübeck Universitet; Babor TF, Higgins-Biddle JC, Saunders JB, Monteiro MG, Dependence WHODoMHaS.

AUDIT : the alcohol use disorders identification test : guidelines for use in primary health care. Geneva: World Health Organization; The World Health Organization quality of life assessment WHOQOL : Position paper from the World Health Organization.

Sobell LC, Sobell MB. Timeline follow-Back. In: Litten RZ, Allen JP, editors. Measuring alcohol consumption: psychosocial and biochemical methods. Totowa, NJ: Humana Press; Chapter Google Scholar.

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Lyubomirsky S, Lepper HS. A measure of subjective happiness: preliminary reliability and construct validation. Soc Indic Res. Andersen K, Bogenschutz MP, Bühringer G, Behrendt S, Bilberg R, Braun B, et al. BMC Psychiatry.

SPIRIT [updated 7th June ; cited 8th of November]. Perlick DA, Nelson AH, Mattias K, Selzer J, Kalvin C, Wilber CH, et al. In our own voice-family companion: reducing self-stigma of family members of persons with serious mental illness.

University of Southern Denmark. University of Southern Denmark, Odense University Hospital. OPEN Odense Patient data Explorative Network.

Download references. We gratefully acknowledge the staffs in the participating institutions for their engagement and hard work in this project. We would like to thank Odense Patient Data Explorative Network OPEN for setting up and managing the databases of the study.

We also extend our thanks to Trygfonden, Psykiatriens Forskningsfond, and the University of Southern Denmark for making this project possible. The study is founded by Trygfonden, the University of Southern Denmark and the Region of Southern Denmark. The funders have no impact on the study and collection, analysis, and interpretation of data or on writing this manuscript or other publications.

Unit of Clinical Alcohol Research, Clinical Institute, University of Southern Denmark, J. Winsløws vej 18, , Odense, Denmark. Psychiatric Department, Odense University Hospital, J. Odense Patient Data Explorative Network OPEN , Odense University Hospital, Odense, Denmark.

Section of Biostatistics, University of Copenhagen, Øster Farimagsgade 5, , København K, Denmark. Centre for Alcohol and Drug Research, Department of Psychological and Behavioral Sciences, Aarhus University, Artillerivej 90, 2, København S, Aarhus, Denmark.

Department of Psychiatry and Psychotherapy, University of Lübeck, Ratzeburger Allee , , Lübeck, Germany. You can also search for this author in PubMed Google Scholar. ASN: study design, obtaining of funding, supervision of the project and therapists, and data collection.

CE: study design and statistical strategy. GB: responsible for training of therapists. KA: study design, supervision of project.

MH: responsible for supervision of therapists. RB: project management, study design, statistical strategy, data collection, supervision, development of the database in REDCap, and extradition of news and information flow.

RH: draft manuscript, main author responsible for the manuscript. All authors have been involved in revising the draft critically and have read and approved the final manuscript. Correspondence to Rikke Hellum. This study protocol follows the Standard Protocol Items: Recommendations for interventional trials SPIRIT checklist for recommended items to address in a clinical trial protocol and related documents [ 41 ].

The Study is approved by the Danish Data Protection Agency Region of Southern Denmark project no. The study has been submitted for approval at the Danish Ethical Committee Project-ID: S but was excluded for approval on account of it being a questionnaire survey only.

When CSOs contact the treatment Centers, they will be informed by the therapist, both orally and in writing, about the procedures for attending the study. The CSOs must sign the informed consent document in order to participate in the study.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.

Reprints and permissions. Hellum, R. et al. Community reinforcement and family training CRAFT - design of a cluster randomized controlled trial comparing individual, group and self-help interventions. BMC Public Health 19 , Download citation.

Received : 28 November Accepted : 06 March Published : 14 March Anyone you share the following link with will be able to read this content:. Sorry, a shareable link is not currently available for this article. Provided by the Springer Nature SharedIt content-sharing initiative.

Skip to main content. Search all BMC articles Search. Download PDF. Study protocol Open access Published: 14 March Community reinforcement and family training CRAFT - design of a cluster randomized controlled trial comparing individual, group and self-help interventions Rikke Hellum ORCID: orcid.

Abstract Background Around , people in Denmark engage in harmful use of alcohol with , suffering from outright alcohol dependence. Methods The study is a three-arm, cluster randomized controlled trial: A: individual CRAFT, group CRAFT, and CRAFT as a self-help intervention.

Discussion We expect to establish evidence as to whether CRAFT is efficient in a Danish treatment setting and whether CRAFT is most effective at individual, group or self-help material only.

Trial registration Clinical trials. Background It is estimated that , people in Denmark engage in harmful use of alcohol with , suffering from alcohol dependence [ 1 ].

Craft sample trials - Continuous ReAssessment with Flexible ExTension in Rare Malignancies (CRAFT) is an open-label phase II trial for adults with pretreated, locally The Canadian Remote Access Framework for clinical Trials (CRAFT) represents a Tissue Bank ,+ samples from + trials · Network + The sample size of the entire trial varies according to the performance of the individual study arms, ranging between 98 and patients UKCRC Registered Clinical Trials Unit. Design, conduct & analysis; helps to deliver health & social care research across SW Wales & beyond, in academia

Results: At 3-month f-u, II revealed significant higher ADI engagement rates CSOs in both groups reported significant improvements in terms of mental health and family cohesion after having received the intervention, i.

II at 3-months f-u and WL at 6-month f-u. Conclusions: Data show that CRAFT is effective for treating CSOs of alcohol dependent individuals in terms of treatment engagement and improvement of CSOs mental health and family cohesion. Keywords: Alcohol dependence; Community reinforcement; Concerned significant others; Family members; Treatment; Unilateral family therapy.

Copyright © Elsevier Ireland Ltd. All rights reserved. All study arms are based on similar biometrical assumptions, and sample size as well as power calculations are based on Simon's optimal two-stage design for each study arm separately.

The overall aim is to reduce the cumulative hazard of progression-free survival observed within the study PFS2 compared to the cumulative hazard of the progression-free time before inclusion into the study PFS1 using a paired log-rank test.

The sample size of the entire trial varies according to the performance of the individual study arms, ranging between 98 and patients. gene panel testing, performed in a certified laboratory for arms Hematological malignancies and primary brain tumors.

Patients with known progressive brain metastases determined by serial imaging or declining neurologic function in the opinion of the treating physician are not eligible. Patients with symptomatic uncontrolled brain metastases and patients with symptomatic uncontrolled spinal cord compression are not eligible.

Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within the three months prior to enrollment.

All patients with previously treated brain metastases must be clinically stable for at least 1 month after completion of treatment and off steroid treatment for one month, both prior to study enrolment. Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:.

Immune disease as specified below relevant for all patients at Baseline except arm 3 and 5 Alectinib, Inavolisib. Psoriatic arthritis however, patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are permitted provided that they meet the following conditions:.

Stefan Fröhling, Prof. Data sourced from clinicaltrials. Notes about this trial. CRAFT: The NCT-PMO Phase II Trial. Status and phase Enrolling. Phase 2. Metastatic or Locally Advanced Malignancies. Drug: Atezolizumab. Drug: Vemurafenib.

Drug: Trastuzumab. Drug: Pertuzumab. Drug: Inavolisib.

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