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Effectiveness of Assertive Continuing Care for Youth

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ClinicalTrials.gov Identifier: NCT01085188
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : March 11, 2010
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Chestnut Health Systems

Tracking Information
First Submitted Date  ICMJE March 10, 2010
First Posted Date  ICMJE March 11, 2010
Last Update Posted Date March 11, 2010
Study Start Date  ICMJE January 2003
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Assertive Continuing Care for Youth
Official Title  ICMJE Not Provided
Brief Summary Following discharge from residential treatment 324 adolescents are randomly assigned to Assertive Continuing Care with and without motivational incentives in a 2 x 2 factorial design. Clinical outcomes are assessed at 3, 6, 9, and 12 months post discharge.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
Condition  ICMJE Substance Use Disorders
Intervention  ICMJE
  • Behavioral: ACC
    Weekly community based behavioral counseling and case management
  • Behavioral: CM
    Weekly community based prize drawing opportunities contingent upon completed verifiable pro-social activities and clean urine and breath alcohol test results
  • Behavioral: UCC
    recommendation made by discharge counselor upon leaving residential treatment to attend nearest outpatient clinic.
Study Arms  ICMJE
  • Experimental: Assertive Continuing Care (ACC)
    Behavioral intervention comprised of the community reinforcement approach plus case management delivered in home and other community settings to youth and their caregivers.
    Interventions:
    • Behavioral: ACC
    • Behavioral: UCC
  • Experimental: Contingency Management (CM)
    Using a prize drawing system (no, low, medium and large value prizes) with adolescents could earn escalating prize drawing opportunities by completing verifiable pro-social activities and providing negative urine test and breath alcohol test results.
    Interventions:
    • Behavioral: CM
    • Behavioral: UCC
  • Experimental: ACC + CM
    This arm is the combination of arms 1 and 2.
    Interventions:
    • Behavioral: ACC
    • Behavioral: CM
    • Behavioral: UCC
  • Active Comparator: Usual Continuing Care (UCC)
    UCC consists of a discharge recommendation to seek aftercare services at nearest treatment provider to where the patient lived. This service primarily consisted of outpatient group counseling.
    Intervention: Behavioral: UCC
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: March¬†10,¬†2010)
342
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Met DSM-IV diagnostic criteria for abuse or dependence on alcohol or another drug in the past year
  • Been between the ages of 12 and 18 at the time of residential admission; and (c) resided in one of ten Illinois counties targeted for the intervention

Exclusion Criteria:

  • left residential treatment prior to the seventh day
  • did not return to a target county at discharge
  • showed evidence of cognitive impairment that interfered with understanding of study instruments, procedures, or the informed consent process
  • were deemed dangerous to themselves or others during treatment
  • were a ward of child protective services and inaccessible for the intervention
  • met DSM-IV criteria for pathological gambling
  • were discharged to the state department of corrections
  • were already participating in a treatment study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01085188
Other Study ID Numbers  ICMJE 1018-1201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mark D. Godley, Ph.D./Director of Research and Development, Chestnut Health Systems
Study Sponsor  ICMJE Chestnut Health Systems
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE Not Provided
PRS Account Chestnut Health Systems
Verification Date March 2010

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