Home-Based Program to Help Parents of Drug Abusing Adolescents

Study Overview
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Brief Summary
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This project is aimed at parents with a teenager who is already starting to use drugs. The study will test a new, innovative version of a brief intervention. This program will be home based rather than implemented by a counselor in a clinical setting. The stage I activities will involve manual development, parent training development, and a small feasibility study; Stage II involves an efficacy study. Two samples, 110 families each, will participate in the trial. Families will be assigned to either an intervention or control condition. The investigators hypothesize that the home-based intervention will be superior to the control condition. In addition, the investigators expect response to the intervention by the adolescent to be mediated by motivation, cognitions, problem solving, peer drug use, parenting skills and parent self-efficacy.

Detailed Description
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Little attention has been paid to the large group of adolescents who use substances but are not, or not yet, dependent and who could successfully reduce substance use through early intervention. Brief interventions (BI) that are based in cognitive-behavioral and motivational interviewing (CB-MI) strategies provide an option for such mid-level drug abusers (e.g., DSM-IV substance abuse disorder), and extant research on them suggests this approach can be effective with youth. Winters and colleagues have studied with controlled designs the efficacy of brief interventions for application to mild-to-moderate substance abusing adolescents. These studies have used the more traditional approach of counselor-led interventions. This program will be parent-led rather than directed by a counselor in a clinical setting. The stage I activities will involve manual development, parent training development, and a small feasibility study; Stage II involves an efficacy trial. Two samples, 110 families each, will participate in the trial. Families will be assigned to either an intervention or control condition. Data to quantify intervention effects will be obtained by interviewing adolescents and the target parent at multiple time points (baseline and, 3-, 6- and 12-months post baseline). The investigators hypothesize that the home-based intervention will be superior to the control condition. In addition, the investigators expect response to the intervention by the adolescent to be mediated by motivation, cognitions, problem solving, peer drug use, parenting skills and parent self-efficacy. Secondary analyses will focus on additional predictors of intervention effects, and analyses of parent adherence, parent acceptance, and of training adherence. The final product of the work will be a tested comparative intervention protocol that is shaped in an engaging and useful presentation format for use by parents.

Official Title
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Parents as Interventionists for Moderate Drug Abusing Adolescents

Conditions
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Substance-Related Disorders, Drug Addiction, Substance Abuse

Intervention / Treatment
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* Behavioral: Home-Based Intervention
* Behavioral: Educational Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Referral of the adolescent to the Minneapolis metro area participating sites. Both the parent and teen consent to participate. Exclusion Criteria: Current developmental disorder or learning disorder. current or past history of psychosis, or any psychiatric or other condition that may interfere with ongoing participation in the intervention. Suicidal ideation or otherwise judged to be at risk to self or others Unstable or uncontrolled medical illnesses which may interfere with participation in the study. Inability to understand the study procedures or otherwise give informed assent for participation. Failure by the parent to give informed consent for the adolescent.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-Based Intervention<br>Parents will receive a 1-session training on how to deliver a 3-session intervention across a 3-week period. The intervention program begins with a 3 and a half hour training session delivered by the staff Trainer to the participating parent. At the conclusion of training, the parent will be given the intervention manual and supplemental materials. The trainer will phone the parent shortly before session 1, in between each intervention session, and after the third intervention (four phone calls total) to review the objectives and tasks associated with that week's intervention session and to help prepare for the coming session. At the final phone call between the parent and trainer (after the third week), the trainer will deliver to the parent the follow-up resources. | Behavioral: Home-Based Intervention<br>* Parents will be trained through a 3 1/2-hour series on providing a 3-session drug and alcohol intervention program to their adolescent. The parent-led intervention will require parents to meet with their adolescent and work together to help strengthen family cohesiveness, enhance communication, and promote healthy life choices.<br>|
| Active Comparator: Educational Group<br>Parents will receive a 2-hour, education-only psychoeducational curriculum (no parent-led intervention with their teen will occur. | Behavioral: Educational Group<br>* Printed fact sheets will be delivered to parents in a single two-hour session. These fact sheets will provide general drug-related information from the public domain (e.g., substance use trends and well-known dangers of substance involvement), and focus on communication approaches and talking points when discussing substance use with their adolescent (e.g., why adolescents use; how the media may influence attitudes about substances).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent Substance Use | Adolescent participants will complete the Timeline Follow Back in order to assess days of drug use. | Changes from Baseline at 3-, 6-, and 12- months post-baseline | 
| Adolescent Drug Use Consequences | The adolescent participant will complete the Personal Consequences Scale in order to measure their drug use consequences. | Changes from Baseline at 3-, 6-, and 12- months post-baseline | 
| DSM-IV Substance Use Diagnosis | The Adolescent Diagnostic Interview (ADI) will be used to determine a diagnosis. | Changes from Baseline at 3-, 6-, and 12- months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent Mental Health | Adolescent mental health will be measured in two ways. The parent participant will complete the ADI-Parent version and the adolescent participant will complete the Comprehensive Adolescent Severity Inventory (CASI). | Baseline and 3-, 6-, and 12- months post-baseline | 
| Adolescent Treatment History | Parent participants will provide this data when completing the ADI-Parent version. | Baseline and 3-, 6-, and 12- months post-baseline | 
| Program Acceptability | The Credibility/Expectancy Questionnaire (CEQ) will be completed by parents during the training session and the Working Alliance Inventory (WAI) will be completed my the parent after he or she completes the third training session with the adolescent. | Parent Training (average of 2 weeks post-baseline) and Post-Session 3 (average of 6 weeks after the parent training) | 
| Program Satisfaction | Parents will complete a satisfaction questionnaire after completing the third session with the adolescent participant. | Post-Session 3 (average of 6 weeks after the parent training) | 
| Training Fidelity | A training fidelity checklist will be completed by an assessor following the training. | Parent Training (average of 2 weeks post-baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Parent, Substance Abuse, Parent Training, Addiction, Family Intervention, Brief Intervention, Home Intervention