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Substance Use Prevention in Teen Psychiatric Patients (tCheckup)

Primary Purpose

Adolescent Substance Use

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Family Check-up
Parent psychoeducation
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent Substance Use focused on measuring substance use, adolescents, initiation

Eligibility Criteria

12 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brown University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Family Check-up

Psychoeducation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

marijuana use
frequency and quantity of marijuana use in the prior 30 days
marijuana use
frequency and quantity of marijuana use in the prior 30 days
alcohol use
frequency and quantity of alcohol use in the prior 30 days
alcohol use
frequency and quantity of alcohol use in the prior 30 days

Full Information

First Posted
June 2, 2010
Last Updated
July 28, 2012
Sponsor
Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT01170013
Brief Title
Substance Use Prevention in Teen Psychiatric Patients
Acronym
tCheckup
Official Title
Substance Abuse Prevention for Preadolescents With Psychiatric Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Substance Use
Keywords
substance use, adolescents, initiation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Family Check-up
Arm Type
Experimental
Arm Description
Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
Two sessions of psychoeducation for parents regarding adolescent risk behaviors especially substance use
Intervention Type
Behavioral
Intervention Name(s)
Family Check-up
Other Intervention Name(s)
Parent Motivational Interviewing
Intervention Description
Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use
Intervention Type
Behavioral
Intervention Name(s)
Parent psychoeducation
Other Intervention Name(s)
Family psychoeducation
Intervention Description
Two sessions of psychoeducation for parents regarding adolescent risk behaviors. especially substance use
Primary Outcome Measure Information:
Title
Parental monitoring/communication
Description
Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring
Time Frame
3 months
Title
Parental monitoring/communication
Description
Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring
Time Frame
6 months
Secondary Outcome Measure Information:
Title
marijuana use
Description
frequency and quantity of marijuana use in the prior 30 days
Time Frame
3 months
Title
marijuana use
Description
frequency and quantity of marijuana use in the prior 30 days
Time Frame
6 months
Title
alcohol use
Description
frequency and quantity of alcohol use in the prior 30 days
Time Frame
3 months
Title
alcohol use
Description
frequency and quantity of alcohol use in the prior 30 days
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Spirito, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

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Substance Use Prevention in Teen Psychiatric Patients

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