Clinical trial NCT02414074: Adaptive Intervention Strategies in Conduct Problems Prevention
Official title: Adaptive Intervention Strategies in Conduct Problems Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conduct Problems
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: St. Paul Youth Services
First posted: 2015-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Peer Delinquency Scale
timeFrame: 9 months
measure: Family Check-Up Youth Questionnaire - Adolescent
timeFrame: 9 months
measure: Personal Experiences Screening Questionnaire-Adolescent
timeFrame: 9 months
measure: Self-Reported Delinquency Scale-Adolescent (SRD)
timeFrame: 9 months
measure: Inventory of Callous-Unemotional Traits-Youth (ICU)
timeFrame: 9 months
measure: Delayed Discounting Task
timeFrame: 9 months
measure: Dimensional Change Card Sort Task (DCCS)
timeFrame: 9 months
measure: Flanker Task
timeFrame: 9 months
measure: Iowa Gambling Task
timeFrame: 9 months
measure: Family Check-Up Caregiver Questionnaire-Adolescent
timeFrame: 9 months
measure: Behavior Assessment System for Children (BASC-2)
timeFrame: 9 months
measure: Delis Rating of Executive Functions (D-REF)
timeFrame: 9 months
measure: Family Check-Up Caregiver Questionnaire-Family
timeFrame: 9 months
measure: Early Adolescent Temperament Questionnaire-Revised (EAT-Q)
timeFrame: 9 months
measure: Disruptive Behavior Rating Scale (DBRS)
timeFrame: 9 months
measure: Parenting Relationship Questionnaire (PRQ)
timeFrame: 9 months
measure: Inventory of Callous-Unemotional Traits-Parent (ICU)
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Center for Personalized Prevention Research in Children's Mental Health
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Gerald August, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: