Home-Based Program to Help Parents of Drug Abusing Adolescents

Not Applicable

Completed

• Conditions: Drug Addiction; Substance Abuse; Substance-Related Disorders
• Interventions: Behavioral: Home-Based Intervention; Behavioral: Educational Group

• Registration Number: NCT01591239
• Lead Sponsor: Treatment Research Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-04-07
• Study First Submitted QC: 2012-05-01
• Study First Posted: 2012-05-03
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

1. Referral of the adolescent to the Minneapolis metro area participating sites.
2. Both the parent and teen consent to participate.

Exclusion Criteria

1. Current developmental disorder or learning disorder.
2. current or past history of psychosis, or any psychiatric or other condition that may interfere with ongoing participation in the intervention.
3. Suicidal ideation or otherwise judged to be at risk to self or others
4. Unstable or uncontrolled medical illnesses which may interfere with participation in the study.
5. Inability to understand the study procedures or otherwise give informed assent for participation.
6. Failure by the parent to give informed consent for the adolescent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-Based Intervention	Home-Based Intervention	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.
Educational Group	Educational Group	Parents will receive a 2-hour, education-only psychoeducational curriculum (no parent-led intervention with their teen will occur.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Adolescent Mental Health	Baseline and 3-, 6-, and 12- months post-baseline	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).
Program Satisfaction	Post-Session 3 (average of 6 weeks after the parent training)	Parents will complete a satisfaction questionnaire after completing the third session with the adolescent participant.
Adolescent Treatment History	Baseline and 3-, 6-, and 12- months post-baseline	Parent participants will provide this data when completing the ADI-Parent version.
Program Acceptability	Parent Training (average of 2 weeks post-baseline) and Post-Session 3 (average of 6 weeks after the parent training)	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.
Training Fidelity	Parent Training (average of 2 weeks post-baseline)	A training fidelity checklist will be completed by an assessor following the training.

Trial Locations

Locations (1)

University of Minnesota Medical School, Department of Psychiatry; 🇺🇸 Minneapolis, Minnesota, United States