None listed
Conditions
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. 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. Eligible participants will be randomly allocated to receive one of two treatments: i) Concurrent Treatment with Prolonged Exposure – Adolescent (COPE-A); or ii) Person-Centred Therapy (PCT). Both treatments consist of up to 16, one-on-one, sessions with a psychologist, as well as up to four optional caregiver sessions. Participating adolescents (and caregivers) 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 adolescent PTSD symptom severity. A range of secondary outcomes will also be examined including changes adolescent substance use, and behavioural, physical, emotional, social and educational functioning.
Interventions
Intervention: Concurrent Treatment of Post Traumatic Stress Disorder (PTSD) and Substance Use using Prolonged Exposure – Adolescent version (COPE-A).
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, face-to-face sessions. The number of sessions will be based on the psychologist's professional judgeme
Intervention: Concurrent Treatment of Post Traumatic Stress Disorder (PTSD) and Substance Use using Prolonged Exposure – Adolescent version (COPE-A). 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, face-to-face 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, including imaginal and in vivo exposure. Adolescent participants will have the option of nominating a caregiver to undertake an optional caregiver component. Nominated caregivers who agree to participate will be offered a maximum of four, 30 minute, individual sessions with the adolescent's psychologist. over the course of the adolescents’ therapy. The number of sessions will be at the caregivers discretion. Caregiver sessions will comprise psychoeducation about substance use and trauma responses, a rationale for the adolescent program, information about how the caregiver can best support the adolescent through therapy, progress review, and discussion of relapse prevention strategies and aftercare. Therapy sessions will be conducted at times and locations 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 adolescent and caregiver session attendance. All trial therapists will undergo study specific training in how to deliver COPE-A 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). Provisions will be made to assure close therapeutic compliance with the treatment manuals used for both the intervention and control conditions: 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 adolescents’ 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.
Sponsors
Katherine Mills
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
Inclusion criteria: i) aged 12-25 years; ii) alcohol or other drug use in the past month iii) history of problematic alcohol or other drug use (cut-off score of 2 on the CRAFFT); iv) endorse lifetime exposure to at least one traumatic event (according to the PTSD-Reaction Index); v) meet Diagnostic and Statistical Manual of Mental Disorders - 5th edition (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
Exclusion criteria
Exclusion criteria: i) recent history of attempted suicide or current risk of suicide or serious self-harm; ii) current symptoms of psychosis based on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID; score of >1) and clinical observation; iii) cognitive impairment severe enough to impede treatment based on clinical observation; or iv) ongoing trauma-related threat or ongoing unsupervised contact with the alleged perpetrator.
Outcome results
None listed