Aggression ChildhoodSPARENCT06769282
Trauma-Informed Peer Aggression and Dating Violence Prevention for Preteens Receiving Intensive Mental Health Services
A study testing Experimental: Intervention (SPARE) plus Treatment as Usual and Treatment as Usual (TAU) in people with Aggression Childhood and Teen Dating Violence, run by Rhode Island Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 13 years
- Conditions the study is for
- Aggression Childhood, Teen Dating Violence
- What is being tested?
- Experimental: Intervention (SPARE) plus Treatment as Usual and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2024to 30 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (1) aged 11-13 years
- (2) enrolled in CP,
- (3) ability to write and speak in English
- (4) parent/guardian consent.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02906
Elizabeth C Tampke, PhD, (401) 793-8351, elizabeth_tampke@brown.edu
About this study
Official title: Cross-Cutting 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?
Read more
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
Read the 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).
- Conditions
- Aggression Childhood, Teen Dating Violence
- Being tested
- Experimental: Intervention (SPARE) plus Treatment as Usual, Treatment as Usual (TAU)
- Keywords
- Proactive and Reactive Aggression, Teen Dating Violence, Peer aggression, trauma, Adverse Childhood Experiences, partial hospitalization program
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Intervention (SPARE) plus Treatment as UsualBehavioural
Also called SPARE, 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)Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Experimental: Intervention (SPARE) plus Treatment as Usual |
| Treatment As Usual | Active comparator | Arm Description: Participants assigned to this arm will receive treatment as usual at a child partial program. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proactive and Reactive Aggression Questionnaire (PRA)
6 items; 2 subscales to assess proactive and reactive aggression; preteen self-report and parent-report
Measured: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
Secondary outcomes (7)
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
Measured: 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)
35 items; 5 subscales that assess physical abuse, relational abuse, sexual abuse, threatening behavior, verbal-emotional
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, Termination of treatment at the child partial program (average of 7 weeks post-baseline), 3-month follow up, 9-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start25 Oct 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggression ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Elizabeth C Tampke, PhD, Principal investigator, Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769282
- Sponsor's protocol ID
- K01CE003687
- Other IDs
- K01CE003687
- Acronym
- SPARE
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cutting Trauma-Informed Peer Aggression and Dating Violence Prevention for Preteens Receiving Intensive Mental Health Services
- ClinicalTrials.gov ID
- NCT06769282
- Acronym / sponsor ID
- SPARE / K01CE003687
- Conditions
- Aggression Childhood, Teen Dating Violence
- Keywords
- Proactive and Reactive Aggression, Teen Dating Violence, Peer aggression, trauma, Adverse Childhood Experiences, partial hospitalization program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (SPARE) plus Treatment as Usual | Experimental | Behavioral: Experimental: Intervention (SPARE) plus Treatment as UsualParticipants assigned to this arm will receive SPARE in the form of group therapy in addition to treatment as usual at a child partial program. |
| Treatment As Usual | Active comparator | Behavioral: Treatment as Usual (TAU)Arm Description: Participants assigned to this arm will receive treatment as usual at a child partial program. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- (1) aged 11-13 years
- (2) enrolled in CP,
- (3) ability to write and speak in English
- (4) parent/guardian consent.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Intervention (SPARE) plus Treatment as UsualAlso: SPARE, Intervention (SPARE) plus Treatment as Usual5 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. | Behavioural | Intervention (SPARE) plus Treatment as Usual |
| 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 | Behavioural | Treatment As Usual |
Primary outcome
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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elizabeth C Tampke, PhD principal investigator
Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Intervention (SPARE) plus Treatment as Usual and Treatment as Usual (TAU) in people with Aggression Childhood and Teen Dating Violence, run by Rhode Island Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth C Tampke, Ph.D. ((401) 793-8351, elizabeth_tampke@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.