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

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

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

Study Overview

• Status: Recruiting
• Conditions: Teen Dating Violence; Aggression Childhood
• Intervention / Treatment: Behavioral: Experimental: Intervention (SPARE) plus Treatment as Usual; Behavioral: Treatment as Usual (TAU)

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 Type: Interventional
• Enrollment (Estimated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth C Tampke, Ph.D.; Phone Number: (401) 793-8351; Email: elizabeth_tampke@brown.edu

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Recruiting
      • Rhode Island Hospital
      • Contact: Elizabeth C Tampke, PhD; Phone Number: (401) 793-8351; Email: elizabeth_tampke@brown.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (SPARE) plus Treatment as Usual; Participants assigned to this arm will receive SPARE in the form of group therapy in addition to treatment as usual at a child partial program.	Behavioral: Experimental: Intervention (SPARE) plus Treatment as Usual; 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 in self and conflict resolution skills, (4) emotion Regulation, and (5) psycho-education on ACEs and trauma. 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.; Other Names: SPARE; Intervention (SPARE) plus Treatment as Usual
Active Comparator: Treatment As Usual; Arm Description: Participants assigned to this arm will receive treatment as usual at a child partial program.	Behavioral: Treatment as Usual (TAU); Treatment As Usual consists of individual, family, occupational, and art therapy, social skills and emotion regulation groups, and therapeutic milieu. All staff and clinicians are trained in the Incredible Years Parenting Program, which aims reduce behavioral problems, enhance children's social and emotional competence, and improve child-parent interactions. Children also receive individualized treatment tailored for their needs (e.g., sleep interventions). Behavioral health needs staff (BHS) facilitate children's skill acquisition and generalization, implement individualized behavior contingency programs, and assist caregivers with parenting strategies via daily check-ins

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proactive and Reactive Aggression Questionnaire (PRA)	6 items; 2 subscales to assess proactive and reactive aggression; preteen self-report and parent-report	Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance of Couple Violence (ACV)	11 items; 2 subscales that assess acceptance of male-to-female violence and female to male violence; preteen self-report	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)	35 items; 5 subscales that assess physical abuse, relational abuse, sexual abuse, threatening behavior, verbal-emotional	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)	32 items; 4 subscales assessing victimization and perpetration of Threatening/Coercive Behavior and Monitoring Behavior	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)	28 items for self-report; 17 items for parent report; Depression measure; preteen self-report; parent report	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)	41 items; 4 subscales that assess anxiety symptoms related to panic/somatic, generalized anxiety, separation, social, and school avoidance	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	42 items; 4 subscales assessing symptoms of ADHD-Inattention, ADHD-Hyperactivity/Impulsivity, Conduct Disorder, and Oppositional Defiant Disorder; parent report	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	10 items; 3 subscales assessing use of alcohol, tobacco, and marijuana; child report	Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Peer Relations-Short Form	8 items; 2 subscales assessing friendship quality and peer acceptance; preteen report; caregiver report	Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
Problem-Solving Measure for Conflict (PSM-C).	6 items; Assesses problem solving skills, Child report	Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
Conflict Resolution Style Inventory (CRSI)	20 items; 5 subscales assessing styles of Competing, Avoiding, Accommodating, Compromising, and Collaborating; preteen report	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 Emotion Management Scale (CEMS)	33 items; 3 subscales assessing emotion regulation of anger, sadness, and worry; Child and parent report	Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
Child and Adolescent Trauma Screen (CATS)	40 items; 3 subscales assessing occurrence of potential traumatic event, trauma symptoms, and symptom impairment; child and parent report.	Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
Domineering Awareness Questionnaire (AAQ)	10 items; Assesses awareness of domineering behavior and aggression; child report	Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
ACEs Knowledge Questionnaire (AKQ)	10 items; Assesses knowledge of the impact on ACEs on relationships; child-report	Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
Pubertal Development Scale (PDS)	5 items for boys; 6 items for girls; Assesses stage of pubertal development and onset of menarche (girls); child report	Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up

Collaborators and Investigators

• Sponsor: Rhode Island Hospital
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Elizabeth C Tampke, PhD, Rhode Island Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: December 15, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: trauma; Adverse Childhood Experiences; Proactive and Reactive Aggression; Teen Dating Violence; Peer aggression; partial hospitalization program
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Aggression
• Other Study ID Numbers: K01CE003687 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data on preteens (i.e., 11- to 13-year-olds) who receive treatment at a child partial hospitalization program in the Northeast and their caregivers and who consent to participate in study research will be included.
• IPD Sharing Time Frame: The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period. It will be stored in a HIPAA-compliant server at Rhode Island Hospital.
• IPD Sharing Access Criteria: Deidentified dataset will have free and public access. Data will be made available through the CDC repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No