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Adaptive Intervention Strategies in Conduct Problems Prevention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02414074
First Posted: April 10, 2015
Last Update Posted: April 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Mental Health (NIMH)
St. Paul Youth Services
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  Purpose
This pilot study conducts feasibility research to develop adaptive intervention strategies for conduct problems prevention. The adaptive model will stipulate for whom only brief prevention strategies are sufficient and for whom more intensive strategies are necessary. The research will involve youth (10-17 years of age) identified by law enforcement as early offenders and who are referred for pre-court juvenile diversion programming.

Condition Intervention
Conduct Problems Behavioral: Youth Behavioral Intervention Behavioral: Parent Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adaptive Intervention Strategies in Conduct Problems Prevention

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Peer Delinquency Scale [ Time Frame: 9 months ]
    Youth Report

  • Family Check-Up Youth Questionnaire - Adolescent [ Time Frame: 9 months ]
    Youth Report

  • Personal Experiences Screening Questionnaire-Adolescent [ Time Frame: 9 months ]
    Youth Report

  • Self-Reported Delinquency Scale-Adolescent (SRD) [ Time Frame: 9 months ]
    Youth Report

  • Inventory of Callous-Unemotional Traits-Youth (ICU) [ Time Frame: 9 months ]
    Youth Report

  • Delayed Discounting Task [ Time Frame: 9 months ]
    Youth Computer Task

  • Dimensional Change Card Sort Task (DCCS) [ Time Frame: 9 months ]
    Youth Computer Task

  • Flanker Task [ Time Frame: 9 months ]
    Youth Computer Task

  • Iowa Gambling Task [ Time Frame: 9 months ]
    Youth Computer Task

  • Family Check-Up Caregiver Questionnaire-Adolescent [ Time Frame: 9 months ]
    Parent Report

  • Behavior Assessment System for Children (BASC-2) [ Time Frame: 9 months ]
    Parent Report

  • Delis Rating of Executive Functions (D-REF) [ Time Frame: 9 months ]
    Parent Report

  • Family Check-Up Caregiver Questionnaire-Family [ Time Frame: 9 months ]
    Parent Report

  • Early Adolescent Temperament Questionnaire-Revised (EAT-Q) [ Time Frame: 9 months ]
    Parent Report

  • Disruptive Behavior Rating Scale (DBRS) [ Time Frame: 9 months ]
    Parent Report

  • Parenting Relationship Questionnaire (PRQ) [ Time Frame: 9 months ]
    Parent Report

  • Inventory of Callous-Unemotional Traits-Parent (ICU) [ Time Frame: 9 months ]
    Parent Report


Enrollment: 200
Study Start Date: June 2013
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Youth Behavioral Intervention
Teen Intervene Program
Behavioral: Youth Behavioral Intervention
Teen Intervene is an early intervention program for 12-19 year olds.
Other Name: Teen Intervene
Parent Education
Everyday Parenting Program
Behavioral: Parent Education
Everyday Parenting is a parent training curriculum.
Other Name: Everyday Parenting

Detailed Description:
This project proposes to conduct feasibility research to inform implementation of a future full-scale SMART design (i.e., sequential, multiple assignment, randomized trial) that will be used to construct adaptive intervention strategies (AIS) for conduct problems prevention. AIS individualize treatment via decision rules that specify how the type (youth-focused or parent focused) or intensity (low dosage or high dosage) of an intervention should be formulated prior to the beginning of treatment based on youth and family characteristics and/or repeatedly adjusted over time based on proximal outcomes collected during treatment. AIS are needed in conduct problems prevention to address the heterogeneity of at-risk youth and the variability in response to conventional fixed-type preventive interventions. With the present SMART trial each participant will progress through two stages of intervention using a stepped-care framework. In the first stage participants will be randomized to one of two 'brief-type' intervention options, either the youth-focused Teen Intervene-Brief program (TI-B; Winters & Leitten, 2007) or the parent-focused Everyday Parenting-Brief program (EP-B; Dishion et al., 2003, 2010). Responders to either program will be stepped down and monitored over time for maintenance. Non-responders to either program will be stepped up and randomized to one of two second stage 'intensive-type' intervention options that feature either (1) continuation of the first stage option with increased dosage (EP-Expanded or TI-Expanded), or (2) switching to the alternative expanded intervention modality. This feasibility study will enroll high risk youth (10-17 years of age) who have been arrested for status or misdemeanor offenses and referred for pre-court juvenile diversion programming. The aims of this feasibility research are to (1) develop practice infrastructure for implementing a SMART design and assess practitioner adherence to the various intervention sequences, (2) roll out the stepped-care intervention sequences and obtain estimates of recruitment into SMART, attrition at both stages, and overall response rate to first-stage intervention options, (3) describe the demographic and clinical characteristics of the sample of diversion-referred youth who are enrolled in the study, (4) create a latent construct for conduct problems that will be used as the distal outcome, and (5) explore the utility of incorporating secondary tailoring variables (e.g., child and family risk characteristics) in the adaptive intervention model.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Youth ages 10-17
  • Juvenile diversion referral (to community partner agency)

Exclusion Criteria:

  • Pervasive developmental disabilities
  • Serious psychiatric disorders requiring specialized mental health treatment (e.g. psychosis, bipolar disorder, etc.)
  • Substance dependence
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414074


Locations
United States, Minnesota
Center for Personalized Prevention Research in Children's Mental Health
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Mental Health (NIMH)
St. Paul Youth Services
Investigators
Principal Investigator: Gerald August, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02414074     History of Changes
Other Study ID Numbers: R34MH097832 ( U.S. NIH Grant/Contract )
First Submitted: April 3, 2015
First Posted: April 10, 2015
Last Update Posted: April 24, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No