University of Minnesota Medical School, Department of Psychiatry
Minneapolis, Minnesota, 55454, United States
NCT Number: NCT01591239
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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Notify Me12 year–19 year
All sexes
Interventional
Not applicable
Minneapolis, Minnesota, 55454, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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.
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.
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.
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).
Time frame: Baseline and 3-, 6-, and 12- months post-baseline
Parent participants will provide this data when completing the ADI-Parent version.
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.
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.
Time frame: Parent Training (average of 2 weeks post-baseline)
A training fidelity checklist will be completed by an assessor following the training.
Treatment Research Institute
Other
Parents as Interventionists for Moderate Drug Abusing Adolescents
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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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