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Efficacy of scalable approaches to reducing alcohol and other drug use among traumatised young people

A randomised, parallel-group, non-inferiority trial to compare the efficacy of an integrated cognitive-behavioural therapy (COPE-A) for substance use and traumatic stress among adolescents and young adults delivered via telehealth versus in person

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000776505
Enrollment
13
Registered
2024-06-25
Start date
2025-04-08
Completion date
2026-10-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study seeks to examine the efficacy of integrated psychological therapy for co-occurring traumatic stress and substance use among adolescents and young adults aged 12-25 years, delivered in person and via telehealth (i.e., video conferencing). Through this trial we hope to improve our understanding of how best to treat young people experiencing traumatic stress, who are also using alcohol or other drugs, and provide evidence for interventions with maximum reach and accessibility. Eligible participants will be randomly allocated to receive one of two treatments: i) Concurrent Treatment with Prolonged Exposure – Adolescent (COPE-A) delivered via telehealth; or ii) Concurrent Treatment with Prolonged Exposure – Adolescent (COPE-A) delivered in person. Both treatments consist of up to 16, one-on-one, sessions with a psychologist. Participants will also be asked to complete three research interviews at baseline (i.e., study entry), 4- and 12-months post baseline. The primary outcome is change in PTSD symptom severity. It is expected that pre- to post-treatment reductions in PTSD symptom severity in participants receiving COPE-A via telehealth will be non-inferior to reductions observed among participants receiving COPE-A in person. A range of secondary outcomes will also be examined including changes in substance use, emotional functioning and health-related quality of life.

Interventions

COPE-A is an integrated psychological therapy targeting substance use and traumatic stress among adolescents. The therapy will be delivered one-on-one by registered psychologists employed on the project over a maximum of 16 weekly, 60-90 minute, sessions. The number of sessions will be based on the psychologist's professional judgement of progress and participants' preferences. The COPE-A program has been adapted from the efficacious adult COPE therapy (Mills et al., 2012; JAMA 308:690-699) to

COPE-A is an integrated psychological therapy targeting substance use and traumatic stress among adolescents. The therapy will be delivered one-on-one by registered psychologists employed on the project over a maximum of 16 weekly, 60-90 minute, sessions. The number of sessions will be based on the psychologist's professional judgement of progress and participants' preferences. The COPE-A program has been adapted from the efficacious adult COPE therapy (Mills et al., 2012; JAMA 308:690-699) to meet the developmental needs of adolescents. COPE-A comprises gold standard cognitive-behavioural techniques (CBT) for traumatic stress and substance use. The components of the COPE-A program include: 1) psychoeducation; 2) motivational interviewing, 3) enhancing stress management and problem-solving skills; 4) recognising and challenging unhelpful cognitions; and 5) CBT for substance use and trauma-focused CBT therapy for PTSD (including imaginal and in vivo prolonged exposure). A client workbook is used to assist with the delivery of treatment. The workbook contains information corresponding to the therapy sessions, instructions for homework exercises and worksheets to be completed in treatment. The workbook is introduced in the first therapy session and is used flexibly according to the needs the clients (i.e., the psychologist may give the workbook to the participant to work through alongside the psychologist as part of treatment or may keep the workbook and give handouts to the participant during each session). The workbook can be emailed to participants as a pdf with fillable forms or given to the participants in hardcopy. The new treatment, COPE-A (telehealth), will involve delivery of the COPE-A therapy sessions via telehealth (i.e., video conferencing). Modifications have been made to the COPE-A manual to accommodate delivery via video conferencing, including the adaption of worksheets and handouts for digital use and the implementation of additional safety measures. Therapy sessions will be conducted at times convenient to the participant and employ flexible scheduling to minimise logistical barriers to attendance. Participants will also be reminded of scheduled appointments the day prior (e.g., via phone, text message, email). Therapists will keep a log of participant session attendance. All trial therapists will undergo study specific training in how to deliver COPE-A at least one week before commencement of the intervention, including the use of the protocol based treatment manual (3 days, face-to-face, delivered by psychologists experienced in the delivery of CBT for traumatic stress and substance use). Therapists will also be trained in the delivery of telehealth including the technical aspects of the video conferencing software and additional considerations for risk assessment and management and development of the therapeutic relationship. Provisions will be made to ensure close therapeutic compliance with the COPE-A treatment manual: i) therapists will receive regular clinical supervision; ii) the treatment manuals will be taken into each session and a session checklist completed; and iii) with the participants’ consent, all sessions will be audio recorded and reviewed weekly by the project coordinator using a checklist to document compliance (a greater than 90% compliance rate will be required); and iv) 10% of each therapist’s sessions will be randomly selected and rated for compliance by a blind independent assessor. Assessments will be conducted at baseline, end-of-treatment (i.e. 4-months post-baseline) and 12-months post-baseline with the project’s research assistants using a combination of study-specific and standardised semi-structured interviews and questionnaires. All interviews will take approximately 2 hours. These interviews will not be audio recorded.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
12 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

i) aged 12-25 years; ii) alcohol or other drug use (excluding nicotine and use of prescription drugs as prescribed) in the past month; iii) history of problematic alcohol or other drug use (cut-off score of 2 [12-17yrs] or 3 [18-25yrs] on the Car, Relax, Alone, Forget, Family/Friends, Trouble screening tool version 2.1 [CRAFFT 2.1]); iv) endorse lifetime exposure to at least one traumatic event according to the UCLA Child/Adolescent PTSD Reaction Index for DSM-5 (PTSD-RI); v) meet DSM-5 criteria for a subthreshold or full diagnosis of current PTSD (i.e., past month) according to the PTSD-RI (subthreshold diagnosis defined as meeting criteria A (trauma) and endorsing a minimum of one symptom for criteria B (intrusion), C (avoidance), D (negative thoughts or feelings), and E (arousal/reactivity), and meeting criteria F (duration) and G (impairment); vi) fluent in English; vii) access to an electronic device capable of downloading video-conferencing applications for the conduct of sessions; viii) the capacity to attend in person sessions.

Exclusion criteria

i) recent history of attempted suicide or current risk of suicide or serious self-harm; ii) current symptoms of psychosis based on questions derived from the Young Minds Matter (YMM) survey and clinical assessment; xi) cognitive impairment severe enough to impede treatment based on clinical assessment; xii) ongoing trauma-related threat or ongoing unsupervised contact with the alleged perpetrator based on clinical assessment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026