Home-Based Program to Help Parents of Drug Abusing Adolescents
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01591239|
Recruitment Status : Completed
First Posted : May 3, 2012
Last Update Posted : September 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Substance-Related Disorders Drug Addiction Substance Abuse||Behavioral: Home-Based Intervention Behavioral: Educational Group||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||286 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Parents as Interventionists for Moderate Drug Abusing Adolescents|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
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).
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591239
|United States, Minnesota|
|University of Minnesota Medical School, Department of Psychiatry|
|Minneapolis, Minnesota, United States, 55454|
|Principal Investigator:||Ken Winters, Ph.D.||Treatment Research Institute and University of Minnesota|