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

Not Applicable

Recruiting

• Conditions: Aggression Childhood; Teen Dating Violence

• Registration Number: NCT06769282
• Lead Sponsor: Rhode Island Hospital

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).

Study Timeline

• Study Start: 2024-10-25
• Status Verified: 2024-12
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-10
• Last Update Posted: 2025-01-10
• Primary Completion: 2026-06-30
• Study Completion: 2027-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 88

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

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proactive and Reactive Aggression Questionnaire (PRA)	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 Outcome Measures

Name	Time	Method
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	11 items; 2 subscales that assess acceptance of male-to-female violence and female to male violence; preteen self-report
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	35 items; 5 subscales that assess physical abuse, relational abuse, sexual abuse, threatening behavior, verbal-emotional
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	32 items; 4 subscales assessing victimization and perpetration of Threatening/Coercive Behavior and Monitoring Behavior
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	28 items for self-report; 17 items for parent report; Depression measure; preteen self-report; parent report
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	41 items; 4 subscales that assess anxiety symptoms related to panic/somatic, generalized anxiety, separation, social, and school avoidance
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	42 items; 4 subscales assessing symptoms of ADHD-Inattention, ADHD-Hyperactivity/Impulsivity, Conduct Disorder, and Oppositional Defiant Disorder; parent report
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	10 items; 3 subscales assessing use of alcohol, tobacco, and marijuana; child report

Trial Locations

Locations (1)

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States