Substance Use Prevention in Teen Psychiatric Patients

NCT01170013 | Completed Phase 1 DMC

• 1 other identifier: 1R21DA024207
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The earlier a child initiates alcohol and other drug (AOD) use, the greater the risk of long-range problems. This association persists despite changes in national substance use rates over time, indicating its stability and viability as a target for prevention. At the same time, parent monitoring of youth behavior tends to decrease during the adolescent years, creating a source of risk for not only the early onset of AOD use but also escalation. Thus, programs are needed in parenting behaviors and family relationships that are protective in helping pre-adolescent youth to avoid initiation of AOD use and abuse. This is particularly true of children with psychiatric disorders who are at higher risk for developing AOD disorders than nonpsychiatrically disturbed children. The primary goal of this study is to test the effectiveness of a family-centered intervention to reduce the risk of AOD use among pre-adolescent children with a history of emotional/behavioral problems. In this application, the families of 80 youths aged 12-14 years, who have not yet begun AOD use but have been referred for mental health care due to psychiatric symptomatology, will be randomly assigned to receive either an individually tailored family program or standard care. The experimental intervention, which is based on the Family Check-Up model (Dishion \& Kavanagh, 2003), provides a thorough assessment of family strengths and weaknesses as they relate to future risk for AOD use as well as emotional/behavioral problems, and utilizes principles of motivational interviewing to encourage families to change. Follow-up interviews will be conducted at 6 and 12 months after baseline to assess changes in parenting, AOD use, and other risky behaviors.

Conditions

Adolescent Substance Use

Keywords

substance use; adolescents; initiation

Outcome Measures

Primary Outcomes (2)

• Parental monitoring/communication

  Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring

  3 months

• Parental monitoring/communication

  Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring

  6 months

Secondary Outcomes (4)

• marijuana use

  3 months

• marijuana use

  6 months

• alcohol use

  3 months

• alcohol use

  6 months

Study Arms (2)

Family Check-up

EXPERIMENTAL

Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use

Behavioral: Family Check-up

Psychoeducation

ACTIVE COMPARATOR

Two sessions of psychoeducation for parents regarding adolescent risk behaviors especially substance use

Behavioral: Parent psychoeducation

Interventions

Family Check-up BEHAVIORAL

Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use

Also known as: Parent Motivational Interviewing

Family Check-up

Parent psychoeducation BEHAVIORAL

Two sessions of psychoeducation for parents regarding adolescent risk behaviors. especially substance use

Also known as: Family psychoeducation

Psychoeducation

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• the target child is between the ages of 12-14 years old at the start of the project and living at home with at least one parent/guardian
• the target child must be receiving services at a mental health clinic and must screen in with a t- score of 70 or above on one of the DSM-oriented scales (ADHD, ODD, CD, anxiety problems, and affective problems) on the Child Behavior Checklist (i.e. reach the clinical cut-off)
• the child must not report prior AOD use, and
• parental consent and child assent are obtained.

You may not qualify if:

• the target child is actively psychotic, and
• the family is not able to speak and understand English or Spanish well enough to complete study procedures.

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Anthony Spirito, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: July 27, 2010
• Study Start: August 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

US (1)