Home-Based Program to Help Parents of Drug Abusing Adolescents

Substance-Related Disorders Clinical Trial

Official title:

Parents as Interventionists for Moderate Drug Abusing Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591239
• Other study ID #: P50DA027841
• Secondary ID: P50DA027841
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: April 2016

Study information

• Verified date: March 2023
• Source: Public Health Management Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Addictive
• Drug Addiction
• Substance Abuse
• Substance-Related Disorders

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	University of Minnesota Medical School, Department of Psychiatry	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Treatment Research Institute	National Institute on Drug Abuse (NIDA), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Adolescent Treatment History	Parent participants will provide this data when completing the ADI-Parent version.	Baseline and 3-, 6-, and 12- months post-baseline
Secondary	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)
Secondary	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)
Secondary	Training Fidelity	A training fidelity checklist will be completed by an assessor following the training.	Parent Training (average of 2 weeks post-baseline)