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

NCT ID: NCT06769282

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-25

Study Completion Date

2027-03-30

Brief Summary

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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

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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).

Conditions

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Aggression Childhood Teen Dating Violence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Experimental: Intervention (SPARE) plus Treatment as Usual

Intervention Type 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.

Treatment As Usual

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

Group Type ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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SPARE Intervention (SPARE) plus Treatment as Usual

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Rhode Island Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth C Tampke, PhD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Elizabeth C Tampke, Ph.D.

Role: CONTACT

(401) 793-8351

Facility Contacts

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Elizabeth C Tampke, PhD

Role: primary

(401) 793-8351

Other Identifiers

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K01CE003687

Identifier Type: NIH

Identifier Source: secondary_id

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K01CE003687

Identifier Type: NIH

Identifier Source: org_study_id

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