- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01170013
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
Status
Completed
Conditions
Intervention / Treatment
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:
- 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.
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:
|
|
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:
|
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
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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