Clinical trial NCT01591239: Home-Based Program to Help Parents of Drug Abusing Adolescents
Official title: Parents as Interventionists for Moderate Drug Abusing Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Drug Addiction
Substance Abuse
Keywords: Adolescent
Parent
Substance Abuse
Parent Training
Addiction
Family Intervention
Brief Intervention
Home Intervention
Lead sponsor: Public Health Management Corporation
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: National Institute on Drug Abuse (NIDA)
First posted: 2012-05-03
Enrollment: 286
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Adolescent Substance Use
timeFrame: Changes from Baseline at 3-, 6-, and 12- months post-baseline
measure: Adolescent Drug Use Consequences
timeFrame: Changes from Baseline at 3-, 6-, and 12- months post-baseline
measure: DSM-IV Substance Use Diagnosis
timeFrame: Changes from Baseline at 3-, 6-, and 12- months post-baseline
Secondary outcomes:
measure: Adolescent Mental Health
timeFrame: Baseline and 3-, 6-, and 12- months post-baseline
measure: Adolescent Treatment History
timeFrame: Baseline and 3-, 6-, and 12- months post-baseline
measure: Program Acceptability
timeFrame: Parent Training (average of 2 weeks post-baseline) and Post-Session 3 (average of 6 weeks after the parent training)
measure: Program Satisfaction
timeFrame: Post-Session 3 (average of 6 weeks after the parent training)
measure: Training Fidelity
timeFrame: Parent Training (average of 2 weeks post-baseline)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical School, Department of Psychiatry
state: Minnesota
Study officials:
affiliation: Treatment Research Institute and University of Minnesota
name: Ken Winters, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Botzet AM, Dittel C, Birkeland R, Lee S, Grabowski J, Winters KC. Parents as interventionists: Addressing adolescent substance use. J Subst Abuse Treat. 2019 Apr;99:124-133. doi: 10.1016/j.jsat.2019.01.015. Epub 2019 Jan 23.