Home-Based Program to Help Parents of Drug Abusing Adolescents

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Treatment Research Institute
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Ken C. Winters, Treatment Research Institute
ClinicalTrials.gov Identifier:
NCT01591239
First received: April 7, 2012
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Substance-Related Disorders
Drug Addiction
Substance Abuse
Behavioral: Home-Based Intervention
Behavioral: Educational Group

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Parents as Interventionists for Moderate Drug Abusing Adolescents

Further study details as provided by Treatment Research Institute:

Primary Outcome Measures:
  • Adolescent Substance Use [ Time Frame: Changes from Baseline at 3-, 6-, and 12- months post-baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The Adolescent Diagnostic Interview (ADI) will be used to determine a diagnosis.


Secondary Outcome Measures:
  • Adolescent Mental Health [ Time Frame: Baseline and 3-, 6-, and 12- months post-baseline ] [ Designated as safety issue: No ]
    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).

  • Adolescent Treatment History [ Time Frame: Baseline and 3-, 6-, and 12- months post-baseline ] [ Designated as safety issue: No ]
    Parent participants will provide this data when completing the ADI-Parent version.

  • Program Acceptability [ Time Frame: Parent Training (average of 2 weeks post-baseline) and Post-Session 3 (average of 6 weeks after the parent training) ] [ Designated as safety issue: No ]
    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.

  • Program Satisfaction [ Time Frame: Post-Session 3 (average of 6 weeks after the parent training) ] [ Designated as safety issue: No ]
    Parents will complete a satisfaction questionnaire after completing the third session with the adolescent participant.

  • Training Fidelity [ Time Frame: Parent Training (average of 2 weeks post-baseline) ] [ Designated as safety issue: No ]
    A training fidelity checklist will be completed by an assessor following the training.


Estimated Enrollment: 450
Study Start Date: September 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   12 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591239

Contacts
Contact: Andria Botzet 612-273-9858 botze003@umn.edu
Contact: Tamara Fahnhorst 612-273-9856 tamfahn@umn.edu

Locations
United States, Minnesota
University of Minnesota Medical School, Department of Psychiatry Recruiting
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
Treatment Research Institute
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Ken Winters, Ph.D. Treatment Research Institute and University of Minnesota
  More Information

No publications provided

Responsible Party: Ken C. Winters, Senior Scientist, Treatment Research Institute
ClinicalTrials.gov Identifier: NCT01591239     History of Changes
Other Study ID Numbers: P50 DA027841
Study First Received: April 7, 2012
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Treatment Research Institute:
Adolescent
Parent
Substance Abuse
Parent Training
Addiction
Family Intervention
Brief Intervention
Home Intervention

Additional relevant MeSH terms:
Substance-Related Disorders
Behavior, Addictive
Mental Disorders
Compulsive Behavior
Impulsive Behavior

ClinicalTrials.gov processed this record on July 20, 2014