- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02414074
Adaptive Intervention Strategies in Conduct Problems Prevention
October 30, 2019 updated by: University of Minnesota
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
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
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55415
- Center for Personalized Prevention Research in Children's Mental Health
-
-
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
10 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Youth Behavioral Intervention
Teen Intervene Program
|
Teen Intervene is an early intervention program for 12-19 year olds.
Other Names:
|
Other: Parent Education
Everyday Parenting Program
|
Everyday Parenting is a parent training curriculum.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peer Delinquency Scale
Time Frame: 9 months
|
Youth Report
|
9 months
|
Family Check-Up Youth Questionnaire - Adolescent
Time Frame: 9 months
|
Youth Report
|
9 months
|
Personal Experiences Screening Questionnaire-Adolescent
Time Frame: 9 months
|
Youth Report
|
9 months
|
Self-Reported Delinquency Scale-Adolescent (SRD)
Time Frame: 9 months
|
Youth Report
|
9 months
|
Inventory of Callous-Unemotional Traits-Youth (ICU)
Time Frame: 9 months
|
Youth Report
|
9 months
|
Delayed Discounting Task
Time Frame: 9 months
|
Youth Computer Task
|
9 months
|
Dimensional Change Card Sort Task (DCCS)
Time Frame: 9 months
|
Youth Computer Task
|
9 months
|
Flanker Task
Time Frame: 9 months
|
Youth Computer Task
|
9 months
|
Iowa Gambling Task
Time Frame: 9 months
|
Youth Computer Task
|
9 months
|
Family Check-Up Caregiver Questionnaire-Adolescent
Time Frame: 9 months
|
Parent Report
|
9 months
|
Behavior Assessment System for Children (BASC-2)
Time Frame: 9 months
|
Parent Report
|
9 months
|
Delis Rating of Executive Functions (D-REF)
Time Frame: 9 months
|
Parent Report
|
9 months
|
Family Check-Up Caregiver Questionnaire-Family
Time Frame: 9 months
|
Parent Report
|
9 months
|
Early Adolescent Temperament Questionnaire-Revised (EAT-Q)
Time Frame: 9 months
|
Parent Report
|
9 months
|
Disruptive Behavior Rating Scale (DBRS)
Time Frame: 9 months
|
Parent Report
|
9 months
|
Parenting Relationship Questionnaire (PRQ)
Time Frame: 9 months
|
Parent Report
|
9 months
|
Inventory of Callous-Unemotional Traits-Parent (ICU)
Time Frame: 9 months
|
Parent Report
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gerald August, Ph.D., University of Minnesota
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
June 1, 2013
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
April 3, 2015
First Submitted That Met QC Criteria
April 7, 2015
First Posted (Estimate)
April 10, 2015
Study Record Updates
Last Update Posted (Actual)
November 1, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 1304S30941
- R34MH097832 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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