NCT01591239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2012

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 3, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

4.6 years

First QC Date

April 7, 2012

Last Update Submit

March 27, 2023

Conditions

Keywords

AdolescentParentSubstance AbuseParent TrainingAddictionFamily InterventionBrief InterventionHome Intervention

Outcome Measures

Primary Outcomes (3)

  • Adolescent Substance Use

    Adolescent participants will complete the Timeline Follow Back in order to assess days of drug use.

    Changes from Baseline at 3-, 6-, and 12- months post-baseline

  • Adolescent Drug Use Consequences

    The adolescent participant will complete the Personal Consequences Scale in order to measure their drug use consequences.

    Changes from Baseline at 3-, 6-, and 12- months post-baseline

  • DSM-IV Substance Use Diagnosis

    The Adolescent Diagnostic Interview (ADI) will be used to determine a diagnosis.

    Changes from Baseline at 3-, 6-, and 12- months post-baseline

Secondary Outcomes (5)

  • Adolescent Mental Health

    Baseline and 3-, 6-, and 12- months post-baseline

  • Adolescent Treatment History

    Baseline and 3-, 6-, and 12- months post-baseline

  • Program Acceptability

    Parent Training (average of 2 weeks post-baseline) and Post-Session 3 (average of 6 weeks after the parent training)

  • Program Satisfaction

    Post-Session 3 (average of 6 weeks after the parent training)

  • Training Fidelity

    Parent Training (average of 2 weeks post-baseline)

Study Arms (2)

Home-Based Intervention

EXPERIMENTAL

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

Educational Group

ACTIVE COMPARATOR

Parents will receive a 2-hour, education-only psychoeducational curriculum (no parent-led intervention with their teen will occur.

Behavioral: Educational Group

Interventions

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.

Home-Based Intervention

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).

Educational Group

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Referral of the adolescent to the Minneapolis metro area participating sites.
  • Both the parent and teen consent to participate.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Medical School, Department of Psychiatry

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Substance-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Ken Winters, Ph.D.

    Treatment Research Institute and University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2012

First Posted

May 3, 2012

Study Start

September 1, 2011

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations