Home-Based Program to Help Parents of Drug Abusing Adolescents

Parents as Interventionists for Moderate Drug Abusing Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Substance-Related Disorders; Substance Abuse; Drug Addiction
• Intervention / Treatment: Behavioral: Home-Based Intervention; Behavioral: Educational Group

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 Type: Interventional
• Enrollment (Actual): 286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Medical School, Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Home-Based Intervention; 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.
Active Comparator: Educational Group; Parents will receive a 2-hour, education-only psychoeducational curriculum (no parent-led intervention with their teen will occur.	Behavioral: Educational Group; 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).

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Treatment Research Institute
• Collaborators: National Institute on Drug Abuse (NIDA); University of Minnesota
• Investigators: Principal Investigator: Ken Winters, Ph.D., Treatment Research Institute and University of Minnesota

Publications and helpful links

General Publications

• Botzet AM, Dittel C, Birkeland R, Lee S, Grabowski J, Winters KC. Parents as interventionists: Addressing adolescent substance use. J Subst Abuse Treat. 2019 Apr;99:124-133. doi: 10.1016/j.jsat.2019.01.015. Epub 2019 Jan 23.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 7, 2012
• First Submitted That Met QC Criteria: May 1, 2012
• First Posted (Estimate): May 3, 2012

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 27, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Adolescent; Addiction; Parent; Substance Abuse; Parent Training; Family Intervention; Brief Intervention; Home Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Substance-Related Disorders; Behavior, Addictive
• Other Study ID Numbers: P50DA027841 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No