A randomised controlled trial of integrated psychological therapy for traumatic stress and substance use among adolescents aged 12-25 years

Intervention

Intervention code Behaviour , Treatment: Other

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 .... 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.
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Comparison

Control group Active

Active control: Person-centred therapy (PCT) PCT is a psychotherapy that adopts a supportive counselling approach. 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. PCT allows the client to determine the content and direction of sessions. It is based on the assumpti .... Active control: Person-centred therapy (PCT) PCT is a psychotherapy that adopts a supportive counselling approach. 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. PCT allows the client to determine the content and direction of sessions. It is based on the assumption that every individual has the capacity to make personal changes and has the ability and resources within themselves to make the necessary changes for personal growth to occur. If certain conditions are present within the therapeutic relationship, the client will be able to use this capacity to make positive changes. These conditions include genuineness or congruence, unconditional positive regard, and accurate empathy. 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. The 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 aftercare. These sessions will also be based on the principles of PCT. 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 PCT including the use of the protocol based treatment manual (1 hr face-to-face, delivered by a psychologist experienced in the delivery of PCT and brief online videos). 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.
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Outcomes

Outcome: Between-group differences in change in the severity of symptoms of post traumatic stress disorder (PTSD) as measured by scores on the Clinician Administered PTSD Scale - Child and Adolescent version for DSM-5 (CAPS-CA-5).
Timepoint: Baseline, 4-months post-baseline (i.e., post-treatment follow-up), and 12-months post baseline. The 4-month follow-up is the primary time point.