Substance Use Prevention in Teen Psychiatric Patients (tCheckup)

July 28, 2012 updated by: Anthony Spirito, Brown University

Substance Abuse Prevention for Preadolescents With Psychiatric Disorders

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Rhode Island
      • Providence, Rhode Island, United States, 02912
        • Brown University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 16 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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
  2. 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)
  3. the child must not report prior AOD use, and
  4. parental consent and child assent are obtained.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Family Check-up
Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use
Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use
Other Names:
  • Parent Motivational Interviewing
ACTIVE_COMPARATOR: Psychoeducation
Two sessions of psychoeducation for parents regarding adolescent risk behaviors especially substance use
Two sessions of psychoeducation for parents regarding adolescent risk behaviors. especially substance use
Other Names:
  • Family psychoeducation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental monitoring/communication
Time Frame: 3 months
Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring
3 months
Parental monitoring/communication
Time Frame: 6 months
Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
marijuana use
Time Frame: 3 months
frequency and quantity of marijuana use in the prior 30 days
3 months
marijuana use
Time Frame: 6 months
frequency and quantity of marijuana use in the prior 30 days
6 months
alcohol use
Time Frame: 3 months
frequency and quantity of alcohol use in the prior 30 days
3 months
alcohol use
Time Frame: 6 months
frequency and quantity of alcohol use in the prior 30 days
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

June 2, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (ESTIMATE)

July 27, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 31, 2012

Last Update Submitted That Met QC Criteria

July 28, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 1R21DA024207 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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