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Clinical Trials/NCT01591239
NCT01591239
Completed
N/A

Parents as Interventionists for Moderate Drug Abusing Adolescents

Treatment Research Institute1 site in 1 country286 target enrollmentSeptember 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Substance-Related Disorders
Sponsor
Treatment Research Institute
Enrollment
286
Locations
1
Primary Endpoint
Adolescent Substance Use
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
April 2016
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Treatment Research Institute
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Adolescent Substance Use

Time Frame: 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

Time Frame: 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

Time Frame: Changes from Baseline at 3-, 6-, and 12- months post-baseline

The Adolescent Diagnostic Interview (ADI) will be used to determine a diagnosis.

Secondary Outcomes

  • Adolescent Mental Health(Baseline and 3-, 6-, and 12- months post-baseline)
  • Program Satisfaction(Post-Session 3 (average of 6 weeks after the parent training))
  • Adolescent Treatment History(Baseline and 3-, 6-, and 12- months post-baseline)
  • Program Acceptability(Parent Training (average of 2 weeks post-baseline) and Post-Session 3 (average of 6 weeks after the parent training))
  • Training Fidelity(Parent Training (average of 2 weeks post-baseline))

Study Sites (1)

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