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| Name | Class |
|---|---|
| Rhode Island Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Project STRONG | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, 3 months, and 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility based on youth self-representation as male gender
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| Name | Affiliation | Role |
|---|---|---|
| Christie Rizzo, PhD | Northeastern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhode Island Hospital | Providence | Rhode Island | 02905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32940857 | Derived | 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. |
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Families were individually randomized at the level of the dyad, thus our study randomized 119 dyads. Parents and teens were not randomized separately. There were only two study arms, CONTROL families and STRONG families.
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| ID | Title | Description |
|---|---|---|
| FG000 | Waitlist Control | 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. |
| FG001 | Project STRONG | 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. Project STRONG: 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A completer analysis was deemed appropriate as the small sample size of this pilot study could be impacted substantially from inadequate intervention dose. Analyses included intervention families who received an adequate dose of intervention, defined as a minimum of 4 out of 6 intervention modules (n=114/119).
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| ID | Title | Description |
|---|---|---|
| BG000 | Waitlist Control | 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. |
| BG001 | Project STRONG |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Teen Report |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | COMPLETER ANALYSIS | Posted | Count of Participants | Participants | Baseline, 3 months, and 9 months |
|
9 months
Adverse events, as defined by clinicaltrials.gov, were monitored for Parents and Teens throughout the course of the trial
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Waitlist Control | Parents-teen dyads 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. CHRISTIE RIZZO | NORTHEASTERN UNIVERSITY | (617) 373-2486 | C.RIZZO@NORTHEASTERN.EDU |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 1, 2019 | Aug 1, 2019 | Prot_SAP_000.pdf |
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|
| 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. | 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. | 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. | Baseline, 3 months, 9 months |
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.
Project STRONG: 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.
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Age, Continuous | Parent Report | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Teen Report | Count of Participants | Participants |
|
| Sex: Female, Male | Parent Report | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Teen Report | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Parent Report | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Teen Report | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Parent Report | Count of Participants | Participants |
|
| Region of Enrollment | Enrollment was by dyad | Number | participants |
|
| OG001 | Project STRONG | 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. Project STRONG: 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. |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 9 months |
|
|
|
|
| Primary | 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. | COMPLETER ANALYSIS | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 9 months |
|
|
|
|
| Secondary | 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. | COMPLETER ANALYSIS | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 9 months |
|
|
|
|
| Secondary | 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. | COMPLETER ANALYSIS | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, and 9 months |
|
|
|
|
| Secondary | 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. | COMPLETER ANALYSIS | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 9 months |
|
|
|
|
| Secondary | 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. | COMPLETER ANALYSIS | Posted | Mean | Standard Deviation | seconds | Baseline, 3 months, 9 months |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Project STRONG | 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 parent-teen dyads to practice and apply strategies to developmentally appropriate situations. | 0 | 59 | 0 | 59 | 0 | 59 |
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| 9-month AQ Total |
|
| Effect Size (d) |
| .01 |
| 2-Sided |
9-month follow-up between groups effect size of general aggression |
| Superiority |
| Adolescent 9-months ARVQ |
|
| Parent Baseline ARVQ |
|
| Parent 3-month ARVQ |
|
| Parent 9-month ARVQ |
|
| Effect Size (d) |
| -.17 |
| 2-Sided |
9-month follow-up between groups effect size of adolescent attitudes support aggression |
| Superiority |
| Effect Size (d) | .19 | 2-Sided | 3-month follow-up between groups effect size of parent attitudes support aggression | Superiority |
| Effect Size (d) | .20 | 2-Sided | 9-month follow-up between groups effect size of parent attitudes support aggression | Superiority |
| 9-month Short-Term Self-Regulation |
|
| Baseline Long-Term Self-Regulation |
|
| 3-month Long-Term Self-Regulation |
|
| 9-month Long-Term Self-Regulation |
|
| Effect Size (d) |
| .36 |
| 2-Sided |
9-month follow-up between groups effect size of adolescent short-term self-regulation |
| Superiority |
| Effect Size (d) | -.11 | 2-Sided | 3-month follow-up between groups effect size of adolescent long-term self-regulation | Superiority |
| Effect Size (d) | .11 | 2-Sided | 9-month follow-up between groups effect size of adolescent long-term self-regulation | Superiority |
| Adolescent 9-month OFCS |
|
| Adolescent Baseline PFCS |
|
| Adolescent 3-month PFCS |
|
| Adolescent 9-month PFCS |
|
| Adolescent Baseline # of Relationship Topics |
|
| Adolescent 3-month # of Relationship Topics |
|
| Adolescent 9-month # of Relationship Topics |
|
| Parent Baseline OFCS |
|
| Parent 3-month OFCS |
|
| Parent 9-month OFCS |
|
| Parent Baseline PFCS |
|
| Parent 3-month PFCS |
|
| Parent 9-month PFCS |
|
| Parent Baseline # of Relationship Topics |
|
| Parent 3-month # of Relationship Topics |
|
| Parent 9-month # of Relationship Topics |
|
| Effect Size (d) |
| .06 |
| 2-Sided |
9-month follow-up between groups effect size of adolescent reported open family communication |
| Superiority |
| Effect Size (d) | -.15 | 2-Sided | 3-month follow-up between groups effect size of adolescent reported problems in family communication | Superiority |
| Effect Size (d) | .06 | 2-Sided | 9-month follow-up between groups effect size of adolescent reported problems in family communication | Superiority |
| Effect Size (d) | .62 | 2-Sided | 3-month follow-up between groups effect size of adolescent reported number of relationship topics discussed | Superiority |
| Effect Size (d) | .13 | 2-Sided | 9-month follow-up between groups effect size of adolescent reported number of relationship topics discussed | Superiority |
| Effect Size (d) | .15 | 2-Sided | 3-month follow-up between groups effect size of parent reported open family communication | Superiority |
| Effect Size (d) | .01 | 2-Sided | 9-month follow-up between groups effect size of parent reported open family communication | Superiority |
| Effect Size (d) | -.15 | 2-Sided | 3-month follow-up between groups effect size of parent reported problems in family communication | Superiority |
| Effect Size (d) | .25 | 2-Sided | 9-month follow-up between groups effect size of parent reported problems in family communication | Superiority |
| Effect Size (d) | .66 | 2-Sided | 3-month follow-up between groups effect size of parent reported number of relationship topics discussed | Superiority |
| Effect Size (d) | -.10 | 2-Sided | 9-month follow-up between groups effect size of parent reported number of relationship topics discussed | Superiority |
| 9-month ERBS |
|
| Effect Size (d) |
| .32 |
| 2-Sided |
9-month follow-up between groups effect size of adolescent emotion-regulation |
| Superiority |
| 9-month BIRD |
|
| Effect Size (d) |
| .23 |
| 2-Sided |
9-month follow-up between groups effect size of adolescent distress tolerance |
| Superiority |