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Clinical Trials/NCT06769282
NCT06769282
Recruiting
N/A

Cross-Cutting Trauma-Informed Peer Aggression and Dating Violence Prevention for Preteens Receiving Intensive Mental Health Services

Rhode Island Hospital1 site in 1 country88 target enrollmentOctober 25, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aggression Childhood
Sponsor
Rhode Island Hospital
Enrollment
88
Locations
1
Primary Endpoint
Proactive and Reactive Aggression Questionnaire (PRA)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to learn if this intervention (Social Skills, Problem Solving, emotion Regulation, and psycho-Education on Trauma: A Trauma-Informed Peer Aggression and Teen Dating Violence Prevention Program; SPARE) can treat peer aggression and prevent teen dating violence in preteens receiving intensive mental health services. The main questions it aims to answer are:

  • Does receiving SPARE reduce proactive and reactive aggression at post-intervention and 3- and 9-month follow-ups?
  • Does receiving SPARE reduce positive attitude about TDV, prevent TDV behaviors, and improve mental health outcomes at post-intervention and 3- and 9-month follow-ups?

Researchers will compare youth receiving SPARE to youth receiving treatment as usual to see if SPARE results in improved proactive and reactive aggression, TDV attitudes and behaviors, and mental health outcomes.

Participants will:

  • Receive SPARE via group therapy incorporated into their daily programing at an intensive mental health program
  • Complete study questionnaires at program intake and discharge as well as at 3-month and 9-month follow-up assessments

Detailed Description

SPARE will include 5 components: (1) Social skills training, including selecting healthy friends and partners, (2) Problem solving with emphasis on positive outcomes of nonaggressive solutions, (3) Awareness of domineering behavior and conflict resolution skills, (4) emotion Regulation, and (5) psycho-Education on ACEs and trauma. SPARE is group-based each of the 5 treatment components are designed to be delivered in two 45-minute sessions per week (see Table 3), for a total of 10 sessions. Each session will include 30 minutes of didactic instruction on the component with developmentally engaging activities to illustrate concepts and an individually tailored 15-minute narrative and mindfulness activity, which may address a traumatic memory depending on youth need and receptivity. SPARE will be delivered by the PI and will replace a social skills group twice a week at CP when it is implemented. SPARE will be implemented in two sites of a child partial hospitalization program (A \& B). Both sites CP serve youth 7-13 years old who (1) require services more intensive than outpatient care or (2) are transitioning from higher care (e.g., inpatient). Youth attend CP for 6 hours a day Monday through Friday. The modal length of stay for youth is 7 weeks. To minimize disruptions in CP care, SPARE will be implemented continuously at one site for 6 months (Active Phase) while TAU data is collected from the other site. After 6 months, conditions at each site will flip, resulting in approximately 5 cohorts of SPARE per site (n=88). Sites A and B will be randomly assigned using yoked randomization to Active Phase or TAU first. During Active Phase, all youth ≥11 years will receive SPARE two days per week (regardless of research eligibility).

Registry
clinicaltrials.gov
Start Date
October 25, 2024
End Date
March 30, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • (1) aged 11-13 years
  • (2) enrolled in CP,
  • (3) ability to write and speak in English
  • (4) parent/guardian consent.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Proactive and Reactive Aggression Questionnaire (PRA)

Time Frame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up

6 items; 2 subscales to assess proactive and reactive aggression; preteen self-report and parent-report

Secondary Outcomes

  • Acceptance of Couple Violence (ACV)(Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up)
  • Conflict in Adolescent Dating and Relationship Inventory (CADRI)(Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up)
  • Digital Relationship Behaviors (DRB)(Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up)
  • Children's Depression inventory (CDI-2)(Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up)
  • Screen for Child Anxiety Related Emotional Disorders (SCARED)(Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up)
  • Disruptive Behavior Disorders Scale(Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up)
  • ABCD Substance Use Screener(Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up)

Study Sites (1)

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