Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06769282

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Aggression Childhood Teen Dating Violence Wounds and Injuries

Age range

11 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02906, United States

Location status: Recruiting

Location contact

Elizabeth C Tampke, PhD

CONTACT

[email protected]

(401) 793-8351

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: SPARE, 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

Primary outcomes

  1. 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

    6 items; 2 subscales to assess proactive and reactive aggression; preteen self-report and parent-report

Secondary outcomes

  1. 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

    11 items; 2 subscales that assess acceptance of male-to-female violence and female to male violence; preteen self-report

  2. 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

    35 items; 5 subscales that assess physical abuse, relational abuse, sexual abuse, threatening behavior, verbal-emotional

  3. 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

    32 items; 4 subscales assessing victimization and perpetration of Threatening/Coercive Behavior and Monitoring Behavior

  4. 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

    28 items for self-report; 17 items for parent report; Depression measure; preteen self-report; parent report

  5. 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

    41 items; 4 subscales that assess anxiety symptoms related to panic/somatic, generalized anxiety, separation, social, and school avoidance

  6. 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

    42 items; 4 subscales assessing symptoms of ADHD-Inattention, ADHD-Hyperactivity/Impulsivity, Conduct Disorder, and Oppositional Defiant Disorder; parent report

  7. 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

    10 items; 3 subscales assessing use of alcohol, tobacco, and marijuana; child report

Other outcomes

  1. PROMIS Peer Relations-Short Form

    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

    8 items; 2 subscales assessing friendship quality and peer acceptance; preteen report; caregiver report

  2. Problem-Solving Measure for Conflict (PSM-C).

    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

    6 items; Assesses problem solving skills, Child report

  3. Conflict Resolution Style Inventory (CRSI)

    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

    20 items; 5 subscales assessing styles of Competing, Avoiding, Accommodating, Compromising, and Collaborating; preteen report

  4. Children's Emotion Management Scale (CEMS)

    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

    33 items; 3 subscales assessing emotion regulation of anger, sadness, and worry; Child and parent report

  5. Child and Adolescent Trauma Screen (CATS)

    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

    40 items; 3 subscales assessing occurrence of potential traumatic event, trauma symptoms, and symptom impairment; child and parent report.

  6. Domineering Awareness Questionnaire (AAQ)

    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

    10 items; Assesses awareness of domineering behavior and aggression; child report

  7. ACEs Knowledge Questionnaire (AKQ)

    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

    10 items; Assesses knowledge of the impact on ACEs on relationships; child-report

  8. Pubertal Development Scale (PDS)

    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

    5 items for boys; 6 items for girls; Assesses stage of pubertal development and onset of menarche (girls); child report

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth C Tampke, Ph.D.

CONTACT

[email protected]

(401) 793-8351

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Acronym: SPARE

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.