Substance Use Prevention in Teen Psychiatric Patients (tCheckup)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthony Spirito, Brown University
ClinicalTrials.gov Identifier:
NCT01170013
First received: June 2, 2010
Last updated: July 28, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Adolescent Substance Use
Behavioral: Family Check-up
Behavioral: Parent psychoeducation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Substance Abuse Prevention for Preadolescents With Psychiatric Disorders

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Parental monitoring/communication [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring

  • Parental monitoring/communication [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring


Secondary Outcome Measures:
  • marijuana use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    frequency and quantity of marijuana use in the prior 30 days

  • marijuana use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    frequency and quantity of marijuana use in the prior 30 days

  • alcohol use [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    frequency and quantity of alcohol use in the prior 30 days

  • alcohol use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    frequency and quantity of alcohol use in the prior 30 days


Enrollment: 68
Study Start Date: August 2008
Study Completion Date: December 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Family Check-up
Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use
Behavioral: Family Check-up
Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use
Other Name: Parent Motivational Interviewing
Active Comparator: Psychoeducation
Two sessions of psychoeducation for parents regarding adolescent risk behaviors especially substance use
Behavioral: Parent psychoeducation
Two sessions of psychoeducation for parents regarding adolescent risk behaviors. especially substance use
Other Name: Family psychoeducation

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.

  Eligibility

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170013

Locations
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
Sponsors and Collaborators
Brown University
Investigators
Principal Investigator: Anthony Spirito, PhD Brown University
  More Information

No publications provided

Responsible Party: Anthony Spirito, Professor, Brown University
ClinicalTrials.gov Identifier: NCT01170013     History of Changes
Other Study ID Numbers: 1 R21 DA024207
Study First Received: June 2, 2010
Last Updated: July 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brown University:
substance use
adolescents
initiation

ClinicalTrials.gov processed this record on August 28, 2014