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| ID | Type | Description | Link |
|---|---|---|---|
| K01CE003687 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| Centers for Disease Control and Prevention | FED |
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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:
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (SPARE) plus Treatment as Usual | Experimental | 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. |
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| Treatment As Usual | Active Comparator | Arm Description: Participants assigned to this arm will receive treatment as usual at a child partial program. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proactive and Reactive Aggression Questionnaire (PRA) | 6 items; 2 subscales to assess proactive and reactive aggression; preteen self-report and parent-report | Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of Couple Violence (ACV) | 11 items; 2 subscales that assess acceptance of male-to-female violence and female to male violence; preteen self-report | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS Peer Relations-Short Form | 8 items; 2 subscales assessing friendship quality and peer acceptance; preteen report; caregiver report | Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up |
| Problem-Solving Measure for Conflict (PSM-C). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth C Tampke, Ph.D. | Contact | (401) 793-8351 | elizabeth_tampke@brown.edu |
| Name | Affiliation | Role |
|---|---|---|
| Elizabeth C Tampke, PhD | Rhode Island Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Recruiting | Providence | Rhode Island | 02906 | United States |
Deidentified data on preteens (i.e., 11- to 13-year-olds) who receive treatment at a child partial hospitalization program in the Northeast and their caregivers and who consent to participate in study research will be included.
The duration of preservation and sharing of the data will be a minimum of 10 years after the funding period. It will be stored in a HIPAA-compliant server at Rhode Island Hospital.
Deidentified dataset will have free and public access. Data will be made available through the CDC repository.
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| 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 |
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35 items; 5 subscales that assess physical abuse, relational abuse, sexual abuse, threatening behavior, verbal-emotional |
| 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) | 32 items; 4 subscales assessing victimization and perpetration of Threatening/Coercive Behavior and Monitoring Behavior | 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) | 28 items for self-report; 17 items for parent report; Depression measure; preteen self-report; parent report | 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) | 41 items; 4 subscales that assess anxiety symptoms related to panic/somatic, generalized anxiety, separation, social, and school avoidance | 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 | 42 items; 4 subscales assessing symptoms of ADHD-Inattention, ADHD-Hyperactivity/Impulsivity, Conduct Disorder, and Oppositional Defiant Disorder; parent report | 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 | 10 items; 3 subscales assessing use of alcohol, tobacco, and marijuana; child report | 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 |
| Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up |
| Conflict Resolution Style Inventory (CRSI) | 20 items; 5 subscales assessing styles of Competing, Avoiding, Accommodating, Compromising, and Collaborating; preteen report | 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 Emotion Management Scale (CEMS) | 33 items; 3 subscales assessing emotion regulation of anger, sadness, and worry; Child and parent report | Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up |
| Child and Adolescent Trauma Screen (CATS) | 40 items; 3 subscales assessing occurrence of potential traumatic event, trauma symptoms, and symptom impairment; child and parent report. | Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up |
| Domineering Awareness Questionnaire (AAQ) | 10 items; Assesses awareness of domineering behavior and aggression; child report | Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up |
| ACEs Knowledge Questionnaire (AKQ) | 10 items; Assesses knowledge of the impact on ACEs on relationships; child-report | Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up |
| Pubertal Development Scale (PDS) | 5 items for boys; 6 items for girls; Assesses stage of pubertal development and onset of menarche (girls); child report | Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up |
| ID | Term |
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| D014947 | Wounds and Injuries |
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| ID | Term |
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| D008722 | Methods |
| D013812 | Therapeutics |
| ID | Term |
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| D008919 | Investigative Techniques |
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