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Home-Based Program to Help Parents of Drug Abusing Adolescents

Primary Purpose

Substance-Related Disorders, Drug Addiction, Substance Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-Based Intervention
Educational Group
Sponsored by
Treatment Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders focused on measuring Adolescent, Parent, Substance Abuse, Parent Training, Addiction, Family Intervention, Brief Intervention, Home Intervention

Eligibility Criteria

12 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Minnesota Medical School, Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Home-Based Intervention

Educational Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Adolescent Substance Use
Adolescent participants will complete the Timeline Follow Back in order to assess days of drug use.
Adolescent Drug Use Consequences
The adolescent participant will complete the Personal Consequences Scale in order to measure their drug use consequences.
DSM-IV Substance Use Diagnosis
The Adolescent Diagnostic Interview (ADI) will be used to determine a diagnosis.

Secondary Outcome Measures

Adolescent Mental Health
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
Parent participants will provide this data when completing the ADI-Parent version.
Program Acceptability
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
Parents will complete a satisfaction questionnaire after completing the third session with the adolescent participant.
Training Fidelity
A training fidelity checklist will be completed by an assessor following the training.

Full Information

First Posted
April 7, 2012
Last Updated
March 27, 2023
Sponsor
Treatment Research Institute
Collaborators
University of Minnesota, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01591239
Brief Title
Home-Based Program to Help Parents of Drug Abusing Adolescents
Official Title
Parents as Interventionists for Moderate Drug Abusing Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Treatment Research Institute
Collaborators
University of Minnesota, National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders, Drug Addiction, Substance Abuse
Keywords
Adolescent, Parent, Substance Abuse, Parent Training, Addiction, Family Intervention, Brief Intervention, Home Intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-Based Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Educational Group
Arm Type
Active Comparator
Arm Description
Parents will receive a 2-hour, education-only psychoeducational curriculum (no parent-led intervention with their teen will occur.
Intervention Type
Behavioral
Intervention Name(s)
Home-Based Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational Group
Intervention Description
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).
Primary Outcome Measure Information:
Title
Adolescent Substance Use
Description
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
Title
Adolescent Drug Use Consequences
Description
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
Title
DSM-IV Substance Use Diagnosis
Description
The Adolescent Diagnostic Interview (ADI) will be used to determine a diagnosis.
Time Frame
Changes from Baseline at 3-, 6-, and 12- months post-baseline
Secondary Outcome Measure Information:
Title
Adolescent Mental Health
Description
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
Title
Adolescent Treatment History
Description
Parent participants will provide this data when completing the ADI-Parent version.
Time Frame
Baseline and 3-, 6-, and 12- months post-baseline
Title
Program Acceptability
Description
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
Parent Training (average of 2 weeks post-baseline) and Post-Session 3 (average of 6 weeks after the parent training)
Title
Program Satisfaction
Description
Parents will complete a satisfaction questionnaire after completing the third session with the adolescent participant.
Time Frame
Post-Session 3 (average of 6 weeks after the parent training)
Title
Training Fidelity
Description
A training fidelity checklist will be completed by an assessor following the training.
Time Frame
Parent Training (average of 2 weeks post-baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Referral of the adolescent to the Minneapolis metro area participating sites. Both the parent and teen consent to participate. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Winters, Ph.D.
Organizational Affiliation
Treatment Research Institute and University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical School, Department of Psychiatry
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30797384
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.
Results Reference
derived

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Home-Based Program to Help Parents of Drug Abusing Adolescents

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