Clinical trial NCT06769282: Trauma-Informed Peer Aggression and Dating Violence Prevention for Preteens Receiving Intensive Mental Health Services
Official title: Cross-Cutting Trauma-Informed Peer Aggression and Dating Violence Prevention for Preteens Receiving Intensive Mental Health Services
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aggression Childhood
Teen Dating Violence
Keywords: Proactive and Reactive Aggression
Teen Dating Violence
Peer aggression
trauma
Adverse Childhood Experiences
partial hospitalization program
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2025-01-10
Enrollment: 88
Sex: ALL
Minimum age (years): 11
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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:

* None

Primary outcomes:
measure: Proactive and Reactive Aggression Questionnaire (PRA)
timeFrame: 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:
measure: Acceptance of Couple Violence (ACV)
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: Conflict in Adolescent Dating and Relationship Inventory (CADRI)
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: Digital Relationship Behaviors (DRB)
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: Children's Depression inventory (CDI-2)
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: Screen for Child Anxiety Related Emotional Disorders (SCARED)
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: Disruptive Behavior Disorders Scale
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: ABCD Substance Use Screener
timeFrame: 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:
measure: PROMIS Peer Relations-Short Form
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: Problem-Solving Measure for Conflict (PSM-C).
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: Conflict Resolution Style Inventory (CRSI)
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: Children's Emotion Management Scale (CEMS)
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: Child and Adolescent Trauma Screen (CATS)
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: Domineering Awareness Questionnaire (AAQ)
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: ACEs Knowledge Questionnaire (AKQ)
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
measure: Pubertal Development Scale (PDS)
timeFrame: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Elizabeth C Tampke, PhD
role: PRINCIPAL_INVESTIGATOR
References: