Adolescent Involvement in Parental Substance Abuse Treatment

NCT01576393 | Completed Phase 1

• 2 other identifiers: 2006B0269R01DA023062
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

Given the reciprocal nature of parent-child interaction, involvement of the adolescent in their mother's substance abuse treatment plan might be associated with reductions in adult relapse and improvements in child functioning. These findings would support the assertion that focus on family dynamics in substance abuse treatment programs is an effective use of resources and an important target of intervention efforts. One hundred eighty-three substance abusing mothers and their child (n=61 assigned to each condition) will receive treatment as usual (TAU) and be randomly assigned to 1) Ecologically-based family therapy (EBFT) conducted in the home or 2) Ecologically-based family therapy conducted at the treatment center, or 3) an attention control, Women's Health Education (WHE). In order to examine the endurance of treatment effects, this project will assess the parent and child at 3, 6, 12, and 18 months post-baseline. Hypotheses

1. 1.It is expected that 1) mothers and children assigned to home and office based family therapy will show greater reductions in substance use and improvement in individual and family functioning at post-treatment compared to those in the attention control, and 2) those assigned to home-based family therapy will show greater reductions in substance use and improved individual and family functioning at post-treatment compared to those assigned to office-based family therapy.
2. 2.It is expected that 1) those assigned to home or office based family therapy will continue to maintain improvements in substance use, individual and family domains over time (time by treatment interaction) compared to those assigned to the attention control and 2) those assigned to home-based family therapy will continue to maintain improvements in substance use, individual and family domains over time (time by treatment interaction) compared to those assigned to office-based family therapy.
3. 3.It is hypothesized that improved family interaction skills will mediate substance use, individual and family outcomes.
4. 4.It is expected that EBFT in the home and EBFT in the office will be more cost effective than TAU, and that EBFT in the home will be more cost effective than EBFT in the office

Conditions

Substance Abuse

Keywords

substance abuse; treatment; families

Outcome Measures

Primary Outcomes (1)

• Substance use

  Change in frequency of reported substance use

  baseline, 3, 6, 12 and 18-months

Study Arms (3)

Home-Based family therapy

EXPERIMENTAL

12 home-based family therapy sessions

Behavioral: Home-based Family Therapy

Office-based family therapy

ACTIVE COMPARATOR

12 office-based family therapy sessions

Behavioral: office-based family therapy

Women's Health Education

PLACEBO COMPARATOR

12 womens's health education sessions

Behavioral: WHE

Interventions

Home-based Family Therapy BEHAVIORAL

12 home-based family therapy sessions

Also known as: home-based Ecologically-based Family therapy

Home-Based family therapy

office-based family therapy BEHAVIORAL

12 office-based family therapy sessions

Also known as: Office-based Ecologically-based Family Therapy

Office-based family therapy

WHE BEHAVIORAL

12 Women's Health Education Sessions

Also known as: Women's Health Education Intervention

Women's Health Education

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult mothers seeking outpatient treatment for alcohol or drug abuse or dependence as measured using the computerized diagnostic interview schedule (CDIS; Shaffer, 1992), and who report substance use within the past 90 days
• A child, between the ages of 8 to 16, lives with the mother at least 50% time over the prior 2 years or continuously for the 6 months prior to the assessment interview.
• If more than one 8-16 year old lives in the home, the one with the greater problem severity will be included in the study. Substance use will be probed ("Have you ever used alcohol or drugs?"). If one youth answers yes, and the other answers no, the one who answers yes will be included. If both child answer "yes", then the Form 90 substance use section \[history and current pattern\] will be administered to each. The child who reports the more severe pattern and history of use \[age of onset, type of drug used, frequency of current use\] will be included. If neither youth reports using alcohol or drugs, then the Youth Self-Report (Achenbach \& Edelbrock, 1982) will be administered and the youth with the greater total problem score will be included.
• Family lives within 60 miles of the treatment facility.
• Child and adult agree to participate in the assessment and treatment intervention.

You may not qualify if:

• \. Evidence of unremitted psychosis or other condition which would impair their ability to understand and participate in the intervention or consent for research participation (as determined by CDISC).

Sponsors & Collaborators

• Ohio State University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43081, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Natasha Slesnick, Ph.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 9, 2012
• First Posted: April 12, 2012
• Study Start: August 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: April 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

US (1)