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Completed

NCT Number: NCT01591239

Home-Based Program to Help Parents of 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.

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Key information

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Medical School, Department of Psychiatry

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home-Based Intervention

Behavioral

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

Behavioral

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Adolescent Mental Health

    Time frame: 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).

  2. Adolescent Treatment History

    Time frame: Baseline and 3-, 6-, and 12- months post-baseline

    Parent participants will provide this data when completing the ADI-Parent version.

  3. Program Acceptability

    Time frame: 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.

  4. Program Satisfaction

    Time frame: 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.

  5. Training Fidelity

    Time frame: Parent Training (average of 2 weeks post-baseline)

    A training fidelity checklist will be completed by an assessor following the training.

Sponsors and collaborators

Lead sponsor

Treatment Research Institute

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Minnesota

Registry information

Official study title

Parents as Interventionists for Moderate Drug Abusing Adolescents

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 3, 2012
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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