Craft sample trials

In addition, violence and sexual abuse are often linked to an alcohol problem [ 7 , 9 ]. Indeed, compared to the general Danish population, the frequencies of such symptoms are two to three times more common both among persons with an AUD and among their partners [ 10 , 11 ].

It is estimated that , children in Denmark live in a family with drinking problems [ 12 ]. In the Danish National Health survey [ 13 ], heavy drinkers in the Region of South Denmark were asked where, if at all, they would seek help to reduce drinking.

Most drinkers had no such desire, but were they to consider seeking help, the most common choice would be looking to family and friends, followed by the general practitioner. Choosing to seek specialist treatment ranked very low. For that reason, it makes excellent sense to empower the families and friends of the person suffering from an AUD, enabling them to act in ways that help PWAUDs towards seeking and receiving treatment.

So far, CRAFT is the only one of these methods with any evidence to support that it increases the likelihood of the PWAUD seeking treatment [ 18 ]. CRAFT is aimed at CSOs who struggle, unsuccessfully, to motivate their loved ones to stop drinking and seek treatment.

So far, eight randomized or controlled clinical trials on CRAFT have been carried out on CSOs to alcohol dependents and drug users [ 16 , 18 , 19 , 20 , 22 , 23 , 24 , 25 ]. Three studies focus on alcohol problems [ 16 , 19 , 25 ], three studies on drug users [ 22 , 23 , 24 ], and two studies on both drug users and alcohol dependents [ 18 , 20 ].

One of the studies on drug users studied CRAFT as a supplement to opioid-dependent adults already in treatment [ 24 ]. All studies have been carried out in the USA except one study on alcohol, which was carried out in Germany [ 25 ].

The German study compared CRAFT Immediate Intervention with waiting list and found a significantly higher engagement rate B 1. The American studies showed a two to three times higher impact in getting PWAUD to attend treatment after four to six CRAFT sessions with CSOs, compared with Al-Anon and Johnson Institute interventions [ 26 ].

Several of these studies have rather small samples from 12 to 40 CSOs [ 19 , 20 , 22 ] The original full intervention of CRAFT consists of 12—14 sessions [ 19 ]. Kirby et al. There was no counseling about e. relationship or substance use [ 18 ]. No significant differences in mood and functioning were found between the three interventions, even though it was not a subject in the TEnt intervention.

CRAFT has, until now, been examined and shown effective in the USA and Germany. To our knowledge, studies on CRAFT have also been initiated in the Netherlands ClinicalTrials. gov ID: NCT and Sweden ISRCTN , but the results are not yet published.

In the Netherlands researchers are performing a three-armed RCT with group, self-directed CRAFT or non-intervention addressed to CSOs to alcohol dependents.

In Sweden, the effect of a five-week internet-based CRAFT program is tested versus waiting list ISRCTN , in addition to another study on an online self-help program combined with a parent-training program for partners suffering from alcohol use disorder, versus a brief psycho-education program [ 27 ].

Moreover, a RCT study on CRAFT for CSOs with problem gamblers CRAFT vs. treatment as usual is currently being conducted in Sweden [ 28 ].

Earlier studies performed are based on small populations, and no study of CRAFT has been performed in Denmark so far. Furthermore, to our knowledge, only one effectiveness study, performed in operating treatment institutions and as part of routine praxis, has been conducted [ 29 ].

The study from Dutcher et al. Further, effectiveness studies outside the USA are still essential before large-scale implementation. The efficacy studies and the effectiveness studies performed, so far, indicate that CRAFT is effective for CSOs towards getting the drinking person into treatment and to improve the quality of life of the CSO and the relationship between the drinking person and the CSO [ 16 , 18 , 19 , 20 , 22 , 23 , 24 , 25 ].

Whether CRAFT delivered in group, individual or as self-help material is equally effective is, however, still unknown. The study of Manuel et al.

indicated, that CRAFT in group condition may be just as effective as individual CRAFT, but the study was indeed small and did not compare the two settings directly.

In the study of Manuel et al. Hence, the findings were promising, but not conclusive or significant. Furthermore, groups can be organized as closed groups or open groups.

In closed groups, all CSOs start at the same time and no new members are enrolled, once the treatment has begun. An open group can start when a minimum of two members are enrolled in the study and new members are included continually until the maximum of group members has been reached.

When testing CRAFT in a closed group format, Manuel et al. experienced challenges with the start-up, because it took up to one month to gather enough CSOs to start a group [ 20 ]. Compared to closed groups, open groups can be joined without a waiting period.

Furthermore, an open group format may create opportunities for senior members in the group to share experiences and advice with newcomers [ 20 ]. However, an open group format may also be negatively affected by a constant influx and outflux of people in the group, in addition to not all group members receiving the sessions in a logical order.

A general strength of group therapy, in proportion to individual and self-help, may be that the CSOs meet like-minded individuals and are able to share similar experiences and feelings and support each other. CSOs, randomly assigned to either individual CRAFT or to open group CRAFT, will significantly more often be able to motivate their drinking relative to enter treatment compared to CSOs, randomly assigned to the control condition self-directed CRAFT.

We hypothesize that six sessions of group CRAFT improve the quality of life and psychological functioning of CSOs significantly more than individual CRAFT and self-directed CRAFT. The study is a cluster randomized controlled trial, carried out in public alcohol treatment facilities.

All public alcohol treatment centers in Denmark have been invited to participate in a partnership with the Unit of Clinical Alcohol Research at the University of Southern Denmark. In all, 61 institutions were invited to participate, and 17 institutions agreed to participate in the study. The treatment facilities have been randomized to offer one of the three following CRAFT formats:.

CRAFT as individual format, consisting of six individual sessions with a therapist and a self-help book. CRAFT in an open group format. The groups start when two CSOs have contacted the treatment facility and will then continuously include new members, consisting of six group sessions with one or two therapists, in addition to the participants also getting a self-help book.

Control condition, consisting of CRAFT delivered in a self-directed format and using a self-help book only. Based on the data from Manuel et al. Furthermore, the effect of CRAFT is one-sided as the intervention of CRAFT cannot make the situation inferior for either the CSO or the drinker [ 8 ].

This gives an expected total of CSOs. Consecutive CSOs, who contact a center randomized to conduct either individual CRAFT or open group CRAFT, will be offered the intervention within two weeks of an intake interview.

Consecutive CSOs, who contact a center randomized to the control condition self-directed CRAFT , will be offered self-help material, only. After three months, and when the primary outcome has been measured, the CSOs in this intervention format will, however, have the possibility of an individual follow-up session with a therapist to make sure that the CSOs are helping to move on.

As can be seen from the design, the control group consists of CSOs randomized to self-help intervention. The self-help intervention is chosen as control condition instead of either Treatment as usual or waiting list. Treatment as usual was disregarded since the interventions, currently being offered to the CSOs in the participating treatment centers, differ a lot one from the other, ranging from nothing, to brief advice on the phone, psycho-education, or personal support.

Instead, offering self-help material to the control group serves as a minimal intervention and, for some CSOs, it may even be sufficiently helpful.

Should that be the case, it would constitute an interesting finding and be added to the overall implementation of CRAFT nationwide. The participants of the study are concerned significant others CSO to a person with an AUD.

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. The CSO must fulfill the criteria listed below to be included in the study.

The therapist, who includes the CSO, estimates whether the CSO fulfills the inclusion and exclusion criteria. Informative leaflets and posters have been distributed to participating local authorities, who are committed to distribute the leaflets via social services departments, departments for children and adolescents, and to general practitioners.

Further, we inform about the project on national websites for counseling about alcohol problems such as www. In this study the sessions are compressed to 6 sessions of one hour for individual CRAFT and two hours for group CRAFT in order to test if a shorter period is just as effective as 12—14 sessions Fig.

The group CRAFT and the individual CRAFT interventions cover the following topics [ 8 ]:. Training in recognition of early signs of domestic violence, particularly as new behavioural change techniques are introduced, intentionally designed to be experienced as negative by the PWAUD; development of a safety plan.

Training in effective communication with the PWAUD. Training in positive reinforcement. Learning to reinforce clean and sober behaviour by using small rewards. Training the methods on how and when to suggest treatment to a PWAUD.

Working with how to handle disappointments in a fruitful way. CSOs, randomized to the control condition, will receive the self-help material, only, and are considered controls for the first three months after enrollment.

In addition, we added a chapter about what alcohol dependence is like, in addition to describing alcohol treatment, how it is organized and how it can be sought. The CRAFT studies, so far, indicate that the effect of the face-to-face intervention is mainly seen either during the intervention or shortly after completion of the intervention.

In other words: empowering the CSOs seems to lead to rather immediate changes in relation to treatment-seeking behaviour among PWAUD. Since we expect a higher impact from the face-to-face intervention than from the control condition, all participants in the control condition have the option for a face-to-face session with therapist three months after enrollment in the study, in order to ensure that the participants are feeling sufficiently helped.

The additional face-to face session for the control group is for ethical reasons and postponed in time, in order not to disturb the testing of the interventions.

The therapists delivering the CRAFT intervention will be staff from the participating treatment centers. Typically, the therapists are educated nurses or social workers with extensive experience in the treatment of alcohol abuse disorders. Therapists from the participating centers, randomized to deliver either group-based or individual CRAFT, have received three days free training in CRAFT, funded by the present project.

To avoid disappointment if a participating center is randomized to deliver self-directed CRAFT, the control intervention, and in order to add to the overall implementation of CRAFT nationwide, therapists will be offered identical training free of charge when the enrollment of participants is completed.

During the study, all therapists, delivering the experimental intervention, will receive feedback on recordings of their intervention performance. All face-to-face intervention sessions will be recorded, and feedback will be given on randomly picked recordings.

Data will be collected at baseline t0 , three months t1 , and six months t2 by means of an iPad baseline and by a Web-based battery of questionnaires or by telephone interview at follow-ups. The participants receive up to three reminders for the follow-up questionnaire until they have answered.

Data on whether and when PWAUD start treatment, will be collected from the CSO after three and six months after completion of enrollment of CSOs. The questionnaire will consist of the following instruments Table 1 :.

Data will be analyzed using a mixed effect logistic regression model, mixed effects Poisson regression, and univariate statistical models, including t-tests, and chi2-tests, will be used for descriptive statistics. For some of the quantitative secondary outcomes a mixed effect model for normally distributed data or a random effect quantile regression model will be used.

Strategy for missing data will be based on multiple imputations with special emphasis on the sensitivity of the results of various imputation schemes, as the missing mechanism is likely to be missing not at random.

In view of the fact that the CRAFT intervention has proven highly effective in the US, and since living close to a problem drinker is such a burden to the individual and, finally, because the Danish National Guidelines strongly recommend the implementation of CRAFT, we find it un-ethical and problematical not to offer CRAFT in some form to all the participants, even to the control condition.

However, since we expect less effect of the control condition CRAFT as self-help material , for ethical reasons, the participants in the control group will be offered an individual CRAFT session three month after enrollment.

Training significant others in new communication strategies and new ways of acting, in relation to the problem drinker, may lead to increased tension in the family set-up. Domestic violence is already relatively more frequent in families with problem drinking, thus, an increased risk may be anticipated.

It is, therefore, highly important to address the risk of domestic violence in therapy. Addressing this risk is mandatory in the interventions and includes developing safety plans together with the CSO. It is, however, important to bear in mind that the risk of abuse and suffering, on the part of the CSOs, is even higher if the problem drinking continues unaddressed.

We expect no risks or side-effects for the participants. Data will be collected in Research Electronic Data Capture REDCap.

Baseline data will be collected directly on an iPad. Data from the follow-up points three months and six months after baseline will be collected by means of Web-based questionnaires. All data will be handled and stored by Odense Patient Data Explorative Network OPEN [ 43 ] and safe SharePoint.

The researchers RH, RB, ASN, CE, one data manager, and one statistician will have access to the data and final dataset.

The researcher RH and RB make interim analysis and present interim analysis for the scientific advisory board. The researcher RH and RB are responsible for recording adverse events and other unintended effects of the trial intervention.

Only the investigators have the right to publish the results. Firstly, the results will be published in international peer-reviewed journals. Afterwards, the results will be shared in the press and presented at international conferences.

Moreover, some of the results will be a part of a Ph. The results will also be communicated to the participants and the therapists in the study. The study will be carried out by the Unit of Clinical Alcohol Research UCAR , The Clinical Research Institute, and The University of Southern Denmark.

UCAR is governed by two complementary functions: A Research Office and a Scientific Advisory board. The Research Office is responsible for the general administration of research projects, including the present study, and provides specialized services to researchers.

Regular meetings will take place between The Research Office, key-persons and leaders of the treatment centres, to inform about progress of the study. Furthermore, a monthly newsletter will be sent to all parties involved in the study.

The Scientific Advisory board meets three times a year, to discuss the progress in study. The scientific Advisory board have the right to make the final decision to terminate the project.

The sponsors have no influence on the process. Together with the participating treatment centers, we have evaluated all the procedures. We have also estimated the duration of the entire inclusion period of participants. Regardless that we only have included 60 CSOs in the first four months, we decided to invite more treatment institutions to the project.

This resulted in an additional seven institutions to be trained, randomized and commence the inclusion of CSOs from the first of September The aim of this study is to investigate whether CSOs assigned to individual CRAFT or group CRAFT would be more able to motivate their drinking relative to enter treatment, compared to CSOs randomly assigned to the control condition self-directed CRAFT and, furthermore, to investigate whether six-weeks group CRAFT improves the quality of life and psychological functioning of CSOs significantly more than individual CRAFT and self-directed CRAFT.

We expect to find a higher improvement in the quality of life for the CSOs receiving group CRAFT than the ones receiving individual CRAFT, since the CSOs in the group CRAFT benefit from the dynamics that occur in a group of like-minded individuals. Being part of a group creates a sense of mutual recognition and may lower the feeling of isolation and shame among CSOs [ 42 ].

Individual sessions may, however, be easier to attend, offer more flexibility, and may allow the CSO to work more freely with what is perceived to be most important. We would like to study if there is a difference in life quality for the CSOs whose relatives enter treatment and those who do not self-directed CRAFT.

This study is also the first to study group CRAFT in Europe and the first study using open group format. CRAFT in a group format may be a relatively cheaper solution [ 20 ].

However, individual sessions may be easier to organize in smaller facilities, if waiting lists are to be avoided. If the self-help material proves to be just as effective as other types of intervention it would be a low-cost intervention and easy to implement nationwide.

Alcohol abuse is high taboo in Denmark and CSOs often feel ashamed of the abuse in the family. Therefore, we know it can be hard to attract the CSOs. The knowledge about the free public alcohol treatment in Denmark is rather low. Compared to the USA, where drinking persons were offered alcohol treatment free of charge if the CSO participated in the CRAFT studies, the incentive was higher for both CSO and for PWAUD.

Since treatment for alcohol use disorder in Denmark is tax funded, free to seek and easily available, participation in this CRAFT study cannot be used as a special opportunity for free treatment and, therefore, we may not expect to replicate the high engagement rates from the US studies [ 26 ].

We might also be aware of the fact that not all CSO find it realistic that the drinking person will ever enter treatment.

It can, however, rather be an aim for the CSO to increase their own quality of life and their relationship with the drinking person, only. We expect this study to provide evidence on the efficacy of CRAFT in Denmark and provide an answer as to whether one of the three CRAFT methods are more effective than the other.

Hansen AB, Hvidtfeldt UA, Gronbaek M, Becker U, Nielsen AS, Tolstrup JS. The number of persons with alcohol problems in the Danish population. Scand J Public Health. Article Google Scholar. Schwarz AS, Nielsen B, Nielsen AS. Changes in profile of patients seeking alcohol treatment and treatment outcomes following policy changes.

Zeitschrift fur Gesundheitswissenschaften. J Public Health. Nielsen AS, Nielsen B, Benjaminsen SE, Petersen P, Rask PH, Gansmo AP. Ugeskrift for laeger [Weekly journal for doctors]. Saunders SM, Zygowicz KM, D'Angelo BR. Person-related and treatment-related barriers to alcohol treatment.

J Subst Abus Treat. Schuler MS, Puttaiah S, Mojtabai R, Crum RM. Perceived barriers to treatment for alcohol problems: a latent class analysis.

Psychiatr Serv. World Health Organization W. Global status report on alcohol and health. MAckrill T EA, Lindgaard H. Treatment-seeking adults from families with alcohol problems. What have they been through? What state are they in?

British Association for Counselling and Psychothenapy Research ;12 4. Smith JEMR. Motivating substance abusers to enter treatment : working with family members. New York: Guilford Press; Google Scholar. Lindgaard H. Familier med alkoholproblemer [families with alcohol problems]; Ray GT, Mertens JR, Weisner C.

The excess medical cost and health problems of family members of persons diagnosed with alcohol or drug problems. Med Care. Dawson DA, Grant BF, Chou SP, Stinson FS. The impact of partner alcohol problems on women's physical and mental health.

Alcohol Drugs. Blå kors I Danmark [Blue Cross Denmark]. Region Syddanmark [Region of Southern Demark]. Hvordan har du det? Trivsel, sundhed og sygdom blandt voksne i Region Syddanmark 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. JavaScript seems to be disabled in your browser. For the best experience on our site, be sure to turn on Javascript in your browser.

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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 - 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

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. Secondary Outcome Measures : Progression-free survival [ Time Frame: 24 months median ] Paired Progression-free Survival 2 PFS2 and Progression-free Survival 1 PFS1 Eligibility Criteria Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information Ages Eligible for Study: 18 Years and older Adult, Older Adult Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria:. 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. This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials. gov instead. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.

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Home Search Results Study Record Detail Saved Studies. Save this study. Warning You have reached the maximum number of saved studies CRAFT: The NCT-PMO Phase II Trial The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

gov Identifier: NCT Recruitment Status : Recruiting First Posted : September 16, Last Update Posted : December 14, See Contacts and Locations. View this study on the modernized ClinicalTrials. Study Details Tabular View No Results Posted Disclaimer How to Read a Study Record.

Study Description. Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information. Arms and Interventions. 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.

Trial Packs. Compare Products. Remove This Item Compare. Clear All. Sort By Position Product Name Price Set Descending Direction. Show 16 32 SAMPLE PACK OF TUBES - ALL 3 SIZES AND COLOUR. ORIGIN: UK PACK QUANTITY: Sample Pack CONTENTS: 1 of each size, plus 2 x gold and 2 x black end caps.

Pocket-friendly snacks and treats Google Crzft Di Trial M, De Candia Trialx, Rancati Affordable kitchen essentials, Madeddu F, Craft sample trials R, Di Pierro R. Tdials table for study information Study Type : Interventional Cradt Trial Actual Enrollment : 29 participants Allocation: Samplr Intervention Model: Crafr Assignment Masking: None Open Pocket-friendly snacks and treats Primary Purpose: Treatment Official Title: A Group Version of Community Reinforcement and Family Training CRAFT Compared to Self-Directed CRAFT Delivery and Non-intervention: a Three-armed Randomized Clinical Trial Study Start Date : August Actual Primary Completion Date : October Actual Study Completion Date : February Resource links provided by the National Library of Medicine MedlinePlus Genetics related topics: Alcohol use disorder U. Google Scholar Download references. Article Google Scholar Dawson DA, Grant BF, Chou SP, Stinson FS. Mennesker med alkoholproblemer : baggrund, belastning, behandling. Data were analyzed using Stata version Taking a Holistic Approach to Sample Management and Sample Processing for Your Clinical Trial


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