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Substance Use Prevention in Teen Psychiatric Patients (tCheckup)

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ClinicalTrials.gov Identifier: NCT01170013
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : July 31, 2012
Sponsor:
Information provided by (Responsible Party):
Anthony Spirito, Brown University

Tracking Information
First Submitted Date  ICMJE June 2, 2010
First Posted Date  ICMJE July 27, 2010
Last Update Posted Date July 31, 2012
Study Start Date  ICMJE August 2008
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
  • Parental monitoring/communication [ Time Frame: 3 months ]
    Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring
  • Parental monitoring/communication [ Time Frame: 6 months ]
    Self-report and observational ratings of parent-child interactions with respect to limit setting, communication, and monitoring
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01170013 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
  • marijuana use [ Time Frame: 3 months ]
    frequency and quantity of marijuana use in the prior 30 days
  • marijuana use [ Time Frame: 6 months ]
    frequency and quantity of marijuana use in the prior 30 days
  • alcohol use [ Time Frame: 3 months ]
    frequency and quantity of alcohol use in the prior 30 days
  • alcohol use [ Time Frame: 6 months ]
    frequency and quantity of alcohol use in the prior 30 days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Substance Use Prevention in Teen Psychiatric Patients
Official Title  ICMJE Substance Abuse Prevention for Preadolescents With Psychiatric Disorders
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Adolescent Substance Use
Intervention  ICMJE
  • 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
  • Behavioral: Parent psychoeducation
    Two sessions of psychoeducation for parents regarding adolescent risk behaviors. especially substance use
    Other Name: Family psychoeducation
Study Arms  ICMJE
  • Experimental: Family Check-up
    Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use
    Intervention: Behavioral: Family Check-up
  • Active Comparator: Psychoeducation
    Two sessions of psychoeducation for parents regarding adolescent risk behaviors especially substance use
    Intervention: Behavioral: Parent psychoeducation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 28, 2012)
68
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2010)
80
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01170013
Other Study ID Numbers  ICMJE 1R21DA024207( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anthony Spirito, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anthony Spirito, PhD Brown University
PRS Account Brown University
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP