Digital CRAFT Training for Drug Addiction

Overseen By Calum Handley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: We The Village, Inc.

Disqualifiers: Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this project is to demonstrate digital training efficacy at scale and commercial readiness. This pilot project will advance piloted digital training programs for CRAFT and maximize scalability. In this project, investigators will: Aim 1: Optimize the digital CRAFT training product based on data and feedback from the pilot and commercialization advisors. Aim 2: Conduct a fully powered randomized control trial of 3 levels of digital training (Level 1 - Digital tutorial only \[T\]; Level 2 - Tutorial \& digital training materials for self-study \[TM\]; Level 3 - Tutorial, digital materials, feedback and coaching \[TMC\]) to examine the effects of training on CRAFT knowledge, fidelity, and plus IP treatment entry/retention and counselor skill pre- and post-tutorial, at 12 weeks and at 6 months.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the CRAFT treatment for drug addiction?

Research shows that Community Reinforcement and Family Training (CRAFT) is effective in engaging individuals with alcohol dependence in treatment and improving the well-being of their family members. Although specific studies on drug addiction are limited, CRAFT has been successful in similar contexts, suggesting it could be beneficial for drug addiction as well. ^{1 2 3 4 5}

Is CRAFT training safe for humans?

The available research on CRAFT training, primarily focused on helping family members of people with alcohol problems, does not report any safety concerns for participants. It is generally considered safe for use in humans. ^{1 4 6 7 8}

How is CRAFT Training different from other treatments for drug addiction?

CRAFT Training is unique because it involves family and friends in the treatment process, teaching them how to encourage their loved ones to seek help for drug addiction. Unlike other treatments that focus directly on the person with addiction, CRAFT empowers the support network to create a positive environment that motivates change. ^{1 6 7 8 9}

Eligibility Criteria

This trial is for professionals working with families affected by opioid use disorder (OUD). Participants should be interested in learning about the Community Reinforcement and Family Training (CRAFT) approach to maximize treatment rates of OUD.

Inclusion Criteria

Work in a counselor-related profession

Report having access to a computer and smartphone with internet access, email, and word processing capability

Provide valid locator information to allow research and CRAFT training staff to contact them to schedule study-related appointments

Exclusion Criteria

Participated in the Qualitative Review aspect of the study

Does not complete the baseline assessment requirements

I do not agree to participate in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Digital Training

Participants engage in digital training through tutorials, materials, and coaching over a 6-month period

6 months

Weekly digital engagement

Follow-up

Participants are monitored for CRAFT knowledge, fidelity, and treatment entry/retention at 3 and 6 months

6 months

Treatment Details

Interventions

• CRAFT Training

Trial Overview The study tests three levels of digital training on CRAFT: a basic tutorial, a tutorial with self-study materials, and a comprehensive package including feedback and coaching. The effectiveness will be measured through knowledge acquisition, fidelity to the method, and impact on treatment entry/retention.

Participant Groups

Group I: TMC - Digital Tutorial plus training Materials plus feedback and Coaching Experimental Treatment 3 Interventions

Participants receive the digital tutorial (T) plus the digital Training materials (TM), plus they submit audio recordings of sessions with clients and receive feedback on their application of CRAFT and receive group coaching on how to improve.

Group II: TM - Digital Tutorial plus training Materials Experimental Treatment 2 Interventions

Participants receive the digital tutorial (T), plus access to 15 additional in depth modules of digital training materials also released weekly alongside the tutorial modules. Modules remain available during the 6-month study timeframe. Participants receive weekly contact encouraging engagement in all of the materials available to them.

Group III: T - Digital Tutorial overview Active Control 1 Intervention

A digital tutorial consisting of a curriculum dashboard for review of 20 modules, including videos, PDFs, text and quizzes, which are to be unlocked sequentially over seven weeks. Modules remain available during the 6-month study timeframe. Participants receive weekly contact encouraging engagement in all of the materials available to them.

CRAFT Training is already approved in United States, Canada for the following indications:

Approved in United States as Community Reinforcement and Family Training for:

• Substance use disorder treatment support for family members and friends

Approved in Canada as Community Reinforcement and Family Training for:

• Substance use disorder treatment support for family members and friends

Who Is Running the Clinical Trial?

We The Village, Inc.

Lead Sponsor

Trials

4

Recruited

540+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Public Health Management Corporation

Collaborator

Trials

18

Recruited

5,500+

Findings from Research

The study aims to implement and evaluate the effectiveness of Community Reinforcement and Family Training (CRAFT) for concerned significant others (CSOs) of individuals with alcohol use disorder, involving 405 participants from 24 outpatient clinics in Denmark.

The trial will compare three CRAFT interventions (individual, group, and self-help) over 6 weeks to determine which is most effective in motivating problem drinkers to seek treatment, with outcomes assessed at baseline, 3 months, and 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community reinforcement and family training (CRAFT) - design of a cluster randomized controlled trial comparing individual, group and self-help interventions. Hellum, R., Nielsen, AS., Bischof, G., et al.[2023]

The Community Reinforcement Approach and Family Training (CRAFT) was found to be twice as effective as control groups in helping concerned significant others (CSOs) engage identified patients (IPs) in treatment, based on a systematic review of 14 studies involving 691 participants.

Multi-modality treatment approaches, which included both individual and group sessions, resulted in the highest rates of IP treatment entry (up to 86%), while adaptations targeting gambling addiction showed consistently low engagement rates, highlighting the importance of treatment delivery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community reinforcement and family training and rates of treatment entry: a systematic review. Archer, M., Harwood, H., Stevelink, S., et al.[2021]

The project aims to train parents to help their treatment-resistant adolescents enter community-based treatment, adapting the Community Reinforcement and Family Training (CRAFT) approach specifically for this age group.

Initial pilot results suggest that the tailored CRAFT program could effectively support parents in managing their child's substance abuse, although controlled trials are still needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing Community Reinforcement and Family Training (CRAFT) for Parents of Treatment-Resistant Adolescents. Kirby, KC., Versek, B., Kerwin, ME., et al.[2022]

The Community Reinforcement and Family Training (CRAFT) approach significantly increased treatment engagement rates for alcohol-dependent individuals (40.5% in the immediate intervention group compared to 13.9% in the waitlist group) at the 3-month follow-up.

Both groups of concerned significant others (CSOs) reported improvements in mental health and family cohesion after receiving the CRAFT intervention, indicating its effectiveness in enhancing the well-being of CSOs regardless of the timing of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Community Reinforcement and Family Training for concerned significant others of treatment-refusing individuals with alcohol dependence: A randomized controlled trial. Bischof, G., Iwen, J., Freyer-Adam, J., et al.[2019]

Community Reinforcement and Family Training (CRAFT) is significantly more effective than traditional programs like Al-Anon/Nar-Anon and the Johnson Institute in engaging treatment-resistant individuals with substance use disorders, achieving three times more patient engagement than Al-Anon/Nar-Anon and twice that of the Johnson Institute.

CRAFT not only helps engage patients in treatment but also leads to marked psychosocial and physical improvements for concerned significant others (CSOs), with about two-thirds of treatment-resistant patients attending treatment after just four to six CRAFT sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community reinforcement and family training: an effective option to engage treatment-resistant substance-abusing individuals in treatment. Roozen, HG., de Waart, R., van der Kroft, P.[2022]

The internet-based Community Reinforcement Approach and Family Training (iCRAFT) program did not significantly increase the likelihood of individuals with alcohol use disorders seeking treatment compared to a wait-list group, with only 10 out of 94 participants initiating treatment during the study.

However, participants in the iCRAFT program experienced short-term improvements in depressive symptoms, quality of life, and relational happiness, suggesting some benefits for concerned significant others despite the lack of impact on treatment-seeking behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an Internet-Based Community Reinforcement and Family Training Program to Increase Treatment Engagement for AUD and to Improve Psychiatric Health for CSOs: A Randomized Controlled Trial. EÉk, N., Romberg, K., Siljeholm, O., et al.[2020]

In a study involving 249 concerned significant others (CSOs) of individuals with alcohol problems, the Community Reinforcement and Family Training (CRAFT) intervention showed that 29% of those receiving group or individual sessions reported their loved ones engaged in treatment after three months, compared to 15% for those using self-administered materials.

While the results suggested that group or individual formats may be more effective than self-administered CRAFT, the differences were not statistically significant, indicating that all formats may have potential benefits for encouraging treatment engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Outcome from a cluster-randomized trial of three formats for delivering Community Reinforcement and Family Training (CRAFT) to the significant others of problem drinkers. Hellum, R., Bilberg, R., Andersen, K., et al.[2022]

Community Reinforcement and Family Training (CRAFT) was found to be beneficial for concerned significant others (CSOs) of individuals with alcohol problems, regardless of whether it was delivered in individual or group sessions, based on interviews with 11 female participants.

Key components of CRAFT, such as the 'Communication Element' that focuses on positive reinforcement and understanding alcohol use disorder (AUD), were particularly helpful, along with the acceptance and non-judgmental attitudes from facilitators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How concerned significant others experience Community Reinforcement and Family Training (CRAFT) - a qualitative study. Hellum, R., Bilberg, R., Bischof, G., et al.[2022]

The Community Reinforcement Approach (CRA) is designed to help individuals with substance abuse issues by modifying their environment to make sobriety more rewarding than substance use, focusing on community support from family, friends, and social activities.

The Community Reinforcement and Family Training (CRAFT) program targets individuals who resist treatment by involving their family and friends to encourage them to seek help, demonstrating a unique approach to engaging treatment-refusing individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Community Reinforcement Approach. Meyers, RJ., Smith, JE., Lash, DN.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Community reinforcement and family training (CRAFT) - design of a cluster randomized controlled trial comparing individual, group and self-help interventions. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Community reinforcement and family training and rates of treatment entry: a systematic review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Developing Community Reinforcement and Family Training (CRAFT) for Parents of Treatment-Resistant Adolescents. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Efficacy of the Community Reinforcement and Family Training for concerned significant others of treatment-refusing individuals with alcohol dependence: A randomized controlled trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Community reinforcement and family training: an effective option to engage treatment-resistant substance-abusing individuals in treatment. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy of an Internet-Based Community Reinforcement and Family Training Program to Increase Treatment Engagement for AUD and to Improve Psychiatric Health for CSOs: A Randomized Controlled Trial. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Primary Outcome from a cluster-randomized trial of three formats for delivering Community Reinforcement and Family Training (CRAFT) to the significant others of problem drinkers. [2022]

8. England pubmed.ncbi.nlm.nih.gov

How concerned significant others experience Community Reinforcement and Family Training (CRAFT) - a qualitative study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Community Reinforcement Approach. [2019]