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Recruiting NCT06769282

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

No phase Interventional Aggression Childhood Teen Dating Violence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental: Intervention (SPARE) plus Treatment as Usual, Treatment as Usual (TAU).
Who it may be relevant to
Registry conditions: Aggression Childhood, Teen Dating Violence. Basic parameters: 11 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • 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-minu
  • 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) fa

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Acceptance of Couple Violence (ACV) [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]
  • Conflict in Adolescent Dating and Relationship Inventory (CADRI) [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]
  • Digital Relationship Behaviors (DRB) [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]
  • Children's Depression inventory (CDI-2) [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]
  • Screen for Child Anxiety Related Emotional Disorders (SCARED) [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]
  • Disruptive Behavior Disorders Scale [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]
  • ABCD Substance Use Screener [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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Rhode Island Hospital — Providence

Identifiers

NCT: NCT06769282 · K01CE003687 · K01CE003687

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗