Recruiting

Observational Study

Sponsor:

Rhode Island Hospital

Code:

NCT06769282

Conditions

Aggression Childhood

Teen Dating Violence

Eligibility Criteria

Sex: All

Age: 11 - 13

Healthy Volunteers: Not accepted

Interventions

Experimental: Intervention (SPARE) plus Treatment as Usual

Treatment as Usual (TAU)

Study Details

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

Study ID

NCT06769282

Start date

Oct 25, 2024

Status verified date

Dec, 2024

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 13

Healthy Volunteers: Not accepted

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

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

active comparator: Treatment As Usual

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

Interventions

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.

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02906

Contacts

More Information

Sponsor

Rhode Island Hospital

Last update posted

Jan 10, 2025

Last verified

Dec, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rhode Island Hospital on 2025-01-10.