Adaptive Intervention Strategies in Conduct Problems Prevention

Conduct Problems Clinical Trial

Official title:

Adaptive Intervention Strategies in Conduct Problems Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414074
• Other study ID #: 1304S30941
• Secondary ID: R34MH097832
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Conduct Problems

Intervention

Behavioral:
• Youth Behavioral Intervention
Teen Intervene is an early intervention program for 12-19 year olds.
• Parent Education
Everyday Parenting is a parent training curriculum.

Locations

Country	Name	City	State
United States	Center for Personalized Prevention Research in Children's Mental Health	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	National Institute of Mental Health (NIMH), St. Paul Youth Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peer Delinquency Scale	Youth Report	9 months
Primary	Family Check-Up Youth Questionnaire - Adolescent	Youth Report	9 months
Primary	Personal Experiences Screening Questionnaire-Adolescent	Youth Report	9 months
Primary	Self-Reported Delinquency Scale-Adolescent (SRD)	Youth Report	9 months
Primary	Inventory of Callous-Unemotional Traits-Youth (ICU)	Youth Report	9 months
Primary	Delayed Discounting Task	Youth Computer Task	9 months
Primary	Dimensional Change Card Sort Task (DCCS)	Youth Computer Task	9 months
Primary	Flanker Task	Youth Computer Task	9 months
Primary	Iowa Gambling Task	Youth Computer Task	9 months
Primary	Family Check-Up Caregiver Questionnaire-Adolescent	Parent Report	9 months
Primary	Behavior Assessment System for Children (BASC-2)	Parent Report	9 months
Primary	Delis Rating of Executive Functions (D-REF)	Parent Report	9 months
Primary	Family Check-Up Caregiver Questionnaire-Family	Parent Report	9 months
Primary	Early Adolescent Temperament Questionnaire-Revised (EAT-Q)	Parent Report	9 months
Primary	Disruptive Behavior Rating Scale (DBRS)	Parent Report	9 months
Primary	Parenting Relationship Questionnaire (PRQ)	Parent Report	9 months
Primary	Inventory of Callous-Unemotional Traits-Parent (ICU)	Parent Report	9 months