Substance Use Prevention in Teen Psychiatric Patients

Adolescent Substance Use Clinical Trial

— tCheckup  

Official title:

Substance Abuse Prevention for Preadolescents With Psychiatric Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170013
• Other study ID #: 1R21DA024207
• Status: Completed
• Phase: Phase 1
• First received: June 2, 2010
• Last updated: July 28, 2012
• Start date: August 2008
• Est. completion date: December 2011

Study information

• Verified date: July 2012
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: December 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adolescent Substance Use

Intervention

Behavioral:
• Family Check-up
Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use
• Parent psychoeducation
Two sessions of psychoeducation for parents regarding adolescent risk behaviors. especially substance use

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parental monitoring/communication	Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring	3 months	No
Primary	Parental monitoring/communication	Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring	6 months	No
Secondary	marijuana use	frequency and quantity of marijuana use in the prior 30 days	3 months	No
Secondary	marijuana use	frequency and quantity of marijuana use in the prior 30 days	6 months	No
Secondary	alcohol use	frequency and quantity of alcohol use in the prior 30 days	3 months	No
Secondary	alcohol use	frequency and quantity of alcohol use in the prior 30 days	6 months	No