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

NCT06769282 | Recruiting

• 1 other identifier: K01CE003687
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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

Conditions

Aggression Childhood; Teen Dating Violence

Keywords

Proactive and Reactive Aggression; Teen Dating Violence; Peer aggression; trauma; Adverse Childhood Experiences; partial hospitalization program

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Other Outcomes (8)

• PROMIS Peer Relations-Short Form

  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).

  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)

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

Study Arms (2)

Intervention (SPARE) plus Treatment as Usual

EXPERIMENTAL

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

Treatment As Usual

ACTIVE COMPARATOR

Arm Description: Participants assigned to this arm will receive treatment as usual at a child partial program.

Behavioral: Treatment as Usual (TAU)

Interventions

Experimental: Intervention (SPARE) plus Treatment as Usual BEHAVIORAL

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.

Also known as: SPARE, Intervention (SPARE) plus Treatment as Usual

Intervention (SPARE) plus Treatment as Usual

Treatment as Usual (TAU) BEHAVIORAL

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

Treatment As Usual

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Rhode Island Hospital: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Rhode Island Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Methods; Therapeutics

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Elizabeth C Tampke, PhD

  Rhode Island Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth C Tampke, Ph.D.

CONTACT

(401) 793-8351; elizabeth_tampke@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: January 10, 2025
• Study Start: October 25, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: January 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• Access Criteria: Deidentified dataset will have free and public access. Data will be made available through the CDC repository.

Locations

US (1)