Intimate Partner ViolenceNCT03109184

Violence Prevention for Middle School Boys

A study testing Project STRONG in people with Intimate Partner Violence, run by Northeastern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will develop and test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to decrease adolescent boys' risk for dating violence involvement as well as attitudes supporting relationship aggression. Read more about this study

Who is it for?: Ages 12 to 14 years, men onlyHealthy volunteers can take part
Conditions the study is for: Intimate Partner Violence
What is being tested?: Project STRONG
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 119 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2015to 31 Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 to 14 years
Men only
Healthy volunteers accepted
Child

Who may be able to join

1) adolescent enrolled in the 7th or 8th grade,
2) parent/legal guardian and teen are English speaking,
3) parent/legal guardian is willing to provide consent for the adolescent to participate in the study,
4) adolescent is willing to provide assent for their own participation.

Who cannot join

1) observable cognitive or developmental delays that would preclude participation,
2) residing with participating parent/guardian less than half time

Trial locations and contacts

1 site in 1 country.

United States1 site

Rhode Island Hospital
Providence, Rhode Island, 02905

Other trials in United States

About this study

Official title: Partner Violence Prevention for Middle School Boys: A Dyadic Web-Based Intervention

Read the detailed description

Over the past ten years dating violence (DV) has been recognized as a significant public health problem affecting adolescents. Emerging data suggest that boys and girls have different developmental trajectories toward violence and therefore prevention programs that target their unique pathways to DV are needed. Despite this need, there is a relative dearth of such gender-informed programs for early adolescent boys. This research project aims to prevent the emergence of DV perpetration/ victimization among boys by developing a web-based intervention that is informed by research on gender-specific pathways to violence and harnesses the influence of parents during the early adolescent years.

Among boys, the perpetration of delinquency-related violence and attitudes supporting violence has been found to predict later perpetration of DV. Thus, gender-informed interventions designed to prevent DV in boys need to target skills that underlie violent behavior and attitudes. The goal of this study is to develop and test a web-based intervention to enhance emotion regulation skills and parent-son relationship communication to prevent DV.

Development and testing will occur in three phases. In the Development Phase, the intervention modules will be developed and iteratively reviewed by both a panel of experts familiar with the research in the field as well as an advisory group of parents and teens from the target population. In the Acceptability Testing Phase, testing will be conducted to assess acceptability and feasibility, and this will be followed by revisions to the intervention program based on feedback and observations. During the Randomized Controlled Trial (RCT) Phase, 120 families will complete the intervention program in an observed setting, to ensure fidelity to intervention dosing. Parents and adolescents will complete the program together and then complete assessments of aggressive and risk behaviors, parent-child communication, and emotion regulation at baseline, 3-,and 9-month follow-ups.

Conditions: Intimate Partner Violence
Being tested: Project STRONG
Keywords: Dating violence prevention, Adolescent boys, Middle school, Web-based prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Project STRONGBehavioural
The web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations.

Study groups in NCT03109184
Study group	Role	What they receive
Waitlist Control	No intervention	Parents and teens enrolled in the study and randomized to the control condition wait until they complete their 3-month and 9-month follow-up surveys before completing the web-based program.
Project STRONG	Experimental	The web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations. Receives: Behavioral: Project STRONG

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
The Conflict in Adolescent Dating Relationships Inventory (CADRI) is a behavioral measure of abuse perpetration and victimization. It was completed by teens in reference to conflict or disagreement with a current or recent dating partner. Each question is asked twice, first regarding perpetration and, again in relation to victimization producing a perpetration and a victimization sub scale. Percentages include teens endorsing any perpetration or victimization.
Measured: Baseline, 3 months, and 9 months
Change in General Aggressive Behavior From Baseline to 9 Months
The Aggression Questionnaire (AQ) is a 34-item questionnaire that rates five types of aggression (physical aggression, verbal aggression, anger, hostility, and indirect aggression). Item responses ranged from 1-5, with 1=Not at all like me, 2=A little like me, 3=Somewhat like me, 4=Very much like me, 5=Completely like me. Higher scores indicate more aggression.
Measured: Baseline, 3 months, 9 months
Change in Attitudes About Relationship Violence From Baseline to 9 Months
Adolescent Relationship Violence Questionnaire (ARVQ) is a 22-item questionnaire is a composite measure developed to assess changes in knowledge, attitudes, and methods of dealing with relationship violence. Item responses ranged from 1-4 with 1=strongly agree, 2=agree, 3=disagree 4=strongly disagree. Higher scores indicate more favorable attitudes.
Measured: Baseline, 3 months, and 9 months

Secondary outcomes (4)

Change in Emotion Regulation Skills From Baseline to 9 Months
The Adolescent Self-Regulatory Inventory (ASRI) is a 33 item survey that measures adolescents' use of both functional and dysfunctional emotion regulation strategies. It produces two sub scales measuring short-term and long-term self-regulation. Item responses range from 1-5 with 1= Not at all true for me, 2= Rarely true for me, 3= True some of the time, 4= True most of the time, 5= Really true for me. Items were reverse coded so that higher scores indicate more use of emotion regulation behaviors.
Measured: Baseline, 3 months, and 9 months
Change in Parent-Adolescent Communication From Baseline to 9 Months
Parent Adolescent Communication Survey (PACS) is 20 item survey measuring quality of communication between adolescents and their parents. Adolescents will complete the measure in reference to the parent participating in the intervention with them. This is completed by parents and youth. This scale also produces two sub scales: The Open Family Communication Scale (OFCS) and The Problems in Family Communication Scale (PFCS). Item responses range from 1-5 with 1=Strongly disagree, 2=Moderately disagree, 3=Neither agree neither disagree, 4=Moderately agree, 5=Strongly agree. On the OFCS subscale, higher scores indicate more open communication. One the PFCS subscale, higher scores indicate fewer problems in family communication, thus higher scores on both subscales are favorable.
Measured: Baseline, 3 months, and 9 months
Change in Emotion Regulation Skills Baseline to 9 Months
The Emotion Regulation Behavioral Skills (ERBS) scale is comprised of 8 items rated on a scale of 1 "all the time" to 5 "never" and was specifically created for to detect the use of the specific affect management strategies taught in the Project STRONG intervention. Sample items include "How often did you…get away from whatever was causing your feeling? …talk to someone about whatever was causing your feeling?" Higher scores indicate greater use of emotion regulation skills.
Measured: Baseline, 3 months, 9 months
Change in Distress Tolerance From Baseline to 9 Months
The Behavioral Indicator of Resiliency to Distress (BIRD) is a 5-minute computerized distress tolerance task for adolescents. This measure generates a score of total time that adolescents persist on a frustrating task, which has been linked to distress tolerance. Scores are recorded in milliseconds (ms) with a maximum time participants can persist is 300 seconds (0-300 is the range). Higher score indicate longer persistence during the frustrating task.
Measured: Baseline, 3 months, 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201531 Dec 2018

First posted12 Apr 2017
Study start1 Jan 2015
Primary completion30 Aug 2018
Study completion31 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Intimate Partner ViolenceStudies 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: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03109184
Sponsor's protocol ID: 504616
Status last verified: Mar 2019
First submitted: 6 Apr 2017
Last updated: 20 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Rizzo CJ, Houck C, Barker D, Collibee C, Hood E, Bala K. Project STRONG: an Online, Parent-Son Intervention for the Prevention of Dating Violence among Early Adolescent Boys. Prev Sci. 2021 Feb;22(2):193-204. doi: 10.1007/s11121-020-01168-6. Epub 2020 Sep 17.
PubMed 32940857

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Partner Violence Prevention for Middle School Boys: A Dyadic Web-Based Intervention
ClinicalTrials.gov ID: NCT03109184
Acronym / sponsor ID: 504616
Conditions: Intimate Partner Violence
Keywords: Dating violence prevention, Adolescent boys, Middle school, Web-based prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: Northeastern UniversityUniversity, hospital or other
Collaborators: Rhode Island Hospital
Study start: 1 Jan 2015 (actual)
Primary completion: 30 Aug 2018 (actual)
Study completion: 31 Dec 2018 (actual)
First posted: 12 Apr 2017 (actual)
Results: Posted 20 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Waitlist Control	No intervention	–Parents and teens enrolled in the study and randomized to the control condition wait until they complete their 3-month and 9-month follow-up surveys before completing the web-based program.
Project STRONG	Experimental	Behavioral: Project STRONGThe web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations.

Who may qualify

Ages: 12 to 14 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

1) adolescent enrolled in the 7th or 8th grade,
2) parent/legal guardian and teen are English speaking,
3) parent/legal guardian is willing to provide consent for the adolescent to participate in the study,
4) adolescent is willing to provide assent for their own participation.

Key exclusion criteria (2 listed)

1) observable cognitive or developmental delays that would preclude participation,
2) residing with participating parent/guardian less than half time

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
Project STRONGThe web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations.	Behavioural	Project STRONG

Primary outcome

Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
Time frame: Baseline, 3 months, and 9 months
The Conflict in Adolescent Dating Relationships Inventory (CADRI) is a behavioral measure of abuse perpetration and victimization. It was completed by teens in reference to conflict or disagreement with a current or recent dating partner. Each question is asked twice, first regarding perpetration and, again in relation to victimization producing a perpetration and a victimization sub scale. Percentages include teens endorsing any perpetration or victimization.
Change in General Aggressive Behavior From Baseline to 9 Months
Time frame: Baseline, 3 months, 9 months
The Aggression Questionnaire (AQ) is a 34-item questionnaire that rates five types of aggression (physical aggression, verbal aggression, anger, hostility, and indirect aggression). Item responses ranged from 1-5, with 1=Not at all like me, 2=A little like me, 3=Somewhat like me, 4=Very much like me, 5=Completely like me. Higher scores indicate more aggression.
Change in Attitudes About Relationship Violence From Baseline to 9 Months
Time frame: Baseline, 3 months, and 9 months
Adolescent Relationship Violence Questionnaire (ARVQ) is a 22-item questionnaire is a composite measure developed to assess changes in knowledge, attitudes, and methods of dealing with relationship violence. Item responses ranged from 1-4 with 1=strongly agree, 2=agree, 3=disagree 4=strongly disagree. Higher scores indicate more favorable attitudes.

4 secondary outcomes

Change in Emotion Regulation Skills From Baseline to 9 Months
Time frame: Baseline, 3 months, and 9 months
Change in Parent-Adolescent Communication From Baseline to 9 Months
Time frame: Baseline, 3 months, and 9 months
Change in Emotion Regulation Skills Baseline to 9 Months
Time frame: Baseline, 3 months, 9 months
Change in Distress Tolerance From Baseline to 9 Months
Time frame: Baseline, 3 months, 9 months

Results and safety

Results posted to the registry on 20 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Waitlist Control	60	53
Project STRONG	59	52

Primary outcome: Change in Dating Violence (DV) Perpetration From Baseline to 9 Months

Time frame: Baseline, 3 months, and 9 months. Count of participants. Unit: Participants

Measure	Waitlist Control n = 60	Project STRONG n = 54
Baseline DV Perpetration: DV Absent	46	40
Baseline DV Perpetration: DV Present	14	14
3-month DV Perpetration: DV Absent	50	43
3-month DV Perpetration: DV Present	10	11
9-month DV Perpetration: DV Absent	49	45
9-month DV Perpetration: DV Present	11	9
Baseline DV Victimization: DV Absent	46	41
Baseline DV Victimization: DV Present	14	13

Waitlist Control vs Project STRONG: Odds Ratio (OR): 1.21
Waitlist Control vs Project STRONG: Odds Ratio (OR): 0.61
Waitlist Control vs Project STRONG: Odds Ratio (OR): 1.79

Population analysed: COMPLETER ANALYSIS

Primary outcome: Change in General Aggressive Behavior From Baseline to 9 Months

Time frame: Baseline, 3 months, 9 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Waitlist Control n = 60	Project STRONG n = 54
Baseline AQ Total	2.02 (0.52)	2.01 (0.52)
3-month AQ Total	2.09 (0.61)	2.02 (0.61)
9-month AQ Total	2.03 (0.55)	1.99 (0.6)

Waitlist Control vs Project STRONG: Effect Size (d): -.07
Waitlist Control vs Project STRONG: Effect Size (d): .01

Primary outcome: Change in Attitudes About Relationship Violence From Baseline to 9 Months

Time frame: Baseline, 3 months, and 9 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Waitlist Control n = 60	Project STRONG n = 54
Adolescent Baseline ARVQ	3.01 (0.28)	2.98 (0.30)
Adolescent 3-month ARVQ	3.03 (0.33)	3.00 (0.34)
Adolescent 9-months ARVQ	3.10 (0.34)	3.02 (0.34)
Parent Baseline ARVQ	3.43 (0.33)	3.47 (0.29)
Parent 3-month ARVQ	3.45 (0.31)	3.53 (0.30)
Parent 9-month ARVQ	3.44 (0.32)	3.51 (0.31)

Waitlist Control vs Project STRONG: Effect Size (d): .01
Waitlist Control vs Project STRONG: Effect Size (d): -.17
Waitlist Control vs Project STRONG: Effect Size (d): .19

Population analysed: COMPLETER ANALYSIS

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Waitlist Control	0 of 60 (0%)	0 of 60 (0%)	0 of 60
Project STRONG	0 of 59 (0%)	0 of 59 (0%)	0 of 59

Limitations and caveats (from the sponsor): The primary limitation of this pilot Randomized Controlled Trial was the small sample size. A larger trial with more diverse group of families is needed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32940857Rizzo CJ, Houck C, Barker D, Collibee C, Hood E, Bala K. Project STRONG: an Online, Parent-Son Intervention for the Prevention of Dating Violence among Early Adolescent Boys. Prev Sci. 2021 Feb;22(2):193-204. doi: 10.1007/s11121-020-01168-6. Epub 2020 Sep 17.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Christie Rizzo, PhD principal investigator

Northeastern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Project STRONG in people with Intimate Partner Violence, run by Northeastern University 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 2 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: finished, as of the sponsor's last update on 20 Nov 2019. 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?

Yes. Results are posted in the registry (first posted 20 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Dating Violence (DV) Perpetration From Baseline to 9 Months (time frame: Baseline, 3 months, and 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03109184, which also lists 1 linked publication.

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 20 Nov 2019.