Trial Outcomes & Findings for Violence Prevention for Middle School Boys (NCT NCT03109184)

NCT ID: NCT03109184

Last Updated: 2019-11-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

119 participants

Primary outcome timeframe

Baseline, 3 months, and 9 months

Results posted on

2019-11-20

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
60
59
Overall Study
COMPLETED
53
52
Overall Study
NOT COMPLETED
7
7

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
Overall Study
Lost to Follow-up
6
6
Overall Study
Withdrawal by Subject
1
1

Baseline Characteristics

Violence Prevention for Middle School Boys

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Waitlist Control
n=60 Participants
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
n=54 Participants
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.
Total
n=114 Participants
Total of all reporting groups
Age, Continuous
42.52 years
STANDARD_DEVIATION 7.18 • n=5 Participants
42.54 years
STANDARD_DEVIATION 6.31 • n=7 Participants
42.53 years
STANDARD_DEVIATION 6.75 • n=5 Participants
Sex: Female, Male
Female
54 Participants
n=5 Participants
48 Participants
n=7 Participants
102 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
6 Participants
n=7 Participants
12 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants
n=5 Participants
11 Participants
n=7 Participants
21 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
46 Participants
n=5 Participants
41 Participants
n=7 Participants
87 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants
n=5 Participants
2 Participants
n=7 Participants
6 Participants
n=5 Participants
Race/Ethnicity, Customized
White
43 Participants
n=5 Participants
38 Participants
n=7 Participants
81 Participants
n=5 Participants
Race/Ethnicity, Customized
Non-white
17 Participants
n=5 Participants
15 Participants
n=7 Participants
32 Participants
n=5 Participants
Race/Ethnicity, Customized
Unknown/Not-reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Region of Enrollment
United States
60 participants
n=5 Participants
54 participants
n=7 Participants
114 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3 months, and 9 months

Population: COMPLETER ANALYSIS

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.

Outcome measures

Outcome measures
Measure
Waitlist Control
n=60 Participants
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
n=54 Participants
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.
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
Baseline DV Perpetration · DV Absent
46 Participants
40 Participants
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
Baseline DV Perpetration · DV Present
14 Participants
14 Participants
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
3-month DV Perpetration · DV Absent
50 Participants
43 Participants
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
3-month DV Perpetration · DV Present
10 Participants
11 Participants
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
9-month DV Perpetration · DV Absent
49 Participants
45 Participants
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
9-month DV Perpetration · DV Present
11 Participants
9 Participants
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
Baseline DV Victimization · DV Absent
46 Participants
41 Participants
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
Baseline DV Victimization · DV Present
14 Participants
13 Participants
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
3-month DV Victimization · DV Absent
50 Participants
40 Participants
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
3-month DV Victimization · DV Present
10 Participants
14 Participants
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
9-month DV Victimization · DV Absent
50 Participants
43 Participants
Change in Dating Violence (DV) Perpetration From Baseline to 9 Months
9-month DV Victimization · DV Present
10 Participants
11 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Waitlist Control
n=60 Participants
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
n=54 Participants
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.
Change in General Aggressive Behavior From Baseline to 9 Months
Baseline AQ Total
2.02 score on a scale
Standard Deviation 0.52
2.01 score on a scale
Standard Deviation 0.52
Change in General Aggressive Behavior From Baseline to 9 Months
3-month AQ Total
2.09 score on a scale
Standard Deviation 0.61
2.02 score on a scale
Standard Deviation 0.61
Change in General Aggressive Behavior From Baseline to 9 Months
9-month AQ Total
2.03 score on a scale
Standard Deviation 0.55
1.99 score on a scale
Standard Deviation 0.6

PRIMARY outcome

Timeframe: Baseline, 3 months, and 9 months

Population: COMPLETER ANALYSIS

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.

Outcome measures

Outcome measures
Measure
Waitlist Control
n=60 Participants
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
n=54 Participants
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.
Change in Attitudes About Relationship Violence From Baseline to 9 Months
Adolescent Baseline ARVQ
3.01 score on a scale
Standard Deviation 0.28
2.98 score on a scale
Standard Deviation 0.30
Change in Attitudes About Relationship Violence From Baseline to 9 Months
Adolescent 3-month ARVQ
3.03 score on a scale
Standard Deviation 0.33
3.00 score on a scale
Standard Deviation 0.34
Change in Attitudes About Relationship Violence From Baseline to 9 Months
Adolescent 9-months ARVQ
3.10 score on a scale
Standard Deviation 0.34
3.02 score on a scale
Standard Deviation 0.34
Change in Attitudes About Relationship Violence From Baseline to 9 Months
Parent Baseline ARVQ
3.43 score on a scale
Standard Deviation 0.33
3.47 score on a scale
Standard Deviation 0.29
Change in Attitudes About Relationship Violence From Baseline to 9 Months
Parent 3-month ARVQ
3.45 score on a scale
Standard Deviation 0.31
3.53 score on a scale
Standard Deviation 0.30
Change in Attitudes About Relationship Violence From Baseline to 9 Months
Parent 9-month ARVQ
3.44 score on a scale
Standard Deviation 0.32
3.51 score on a scale
Standard Deviation 0.31

SECONDARY outcome

Timeframe: Baseline, 3 months, and 9 months

Population: COMPLETER ANALYSIS

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.

Outcome measures

Outcome measures
Measure
Waitlist Control
n=60 Participants
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
n=54 Participants
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.
Change in Emotion Regulation Skills From Baseline to 9 Months
Baseline Short-Term Self-Regulation
3.60 score on a scale
Standard Deviation 0.65
3.63 score on a scale
Standard Deviation 0.67
Change in Emotion Regulation Skills From Baseline to 9 Months
3-month Short-Term Self-Regulation
3.55 score on a scale
Standard Deviation 0.76
3.63 score on a scale
Standard Deviation 0.71
Change in Emotion Regulation Skills From Baseline to 9 Months
3-month Long-Term Self-Regulation
3.24 score on a scale
Standard Deviation 0.55
3.21 score on a scale
Standard Deviation 0.52
Change in Emotion Regulation Skills From Baseline to 9 Months
9-month Short-Term Self-Regulation
3.44 score on a scale
Standard Deviation 0.80
3.71 score on a scale
Standard Deviation 0.75
Change in Emotion Regulation Skills From Baseline to 9 Months
Baseline Long-Term Self-Regulation
3.22 score on a scale
Standard Deviation 0.57
3.23 score on a scale
Standard Deviation 0.50
Change in Emotion Regulation Skills From Baseline to 9 Months
9-month Long-Term Self-Regulation
3.23 score on a scale
Standard Deviation 0.51
3.33 score on a scale
Standard Deviation 0.58

SECONDARY outcome

Timeframe: Baseline, 3 months, and 9 months

Population: COMPLETER ANALYSIS

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.

Outcome measures

Outcome measures
Measure
Waitlist Control
n=60 Participants
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
n=54 Participants
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.
Change in Parent-Adolescent Communication From Baseline to 9 Months
Adolescent Baseline OFCS
38.65 score on a scale
Standard Deviation 8.08
37.65 score on a scale
Standard Deviation 10.05
Change in Parent-Adolescent Communication From Baseline to 9 Months
Adolescent 3-months OFCS
36.65 score on a scale
Standard Deviation 9.82
36.87 score on a scale
Standard Deviation 10.18
Change in Parent-Adolescent Communication From Baseline to 9 Months
Adolescent 9-month OFCS
35.13 score on a scale
Standard Deviation 9.96
35.16 score on a scale
Standard Deviation 11.23
Change in Parent-Adolescent Communication From Baseline to 9 Months
Adolescent Baseline PFCS
34.39 score on a scale
Standard Deviation 6.52
32.46 score on a scale
Standard Deviation 7.23
Change in Parent-Adolescent Communication From Baseline to 9 Months
Adolescent 3-month PFCS
34.11 score on a scale
Standard Deviation 7.40
31.98 score on a scale
Standard Deviation 6.98
Change in Parent-Adolescent Communication From Baseline to 9 Months
Adolescent 9-month PFCS
33.60 score on a scale
Standard Deviation 8.03
33.12 score on a scale
Standard Deviation 7.69
Change in Parent-Adolescent Communication From Baseline to 9 Months
Adolescent Baseline # of Relationship Topics
3.24 score on a scale
Standard Deviation 1.79
3.05 score on a scale
Standard Deviation 2.14
Change in Parent-Adolescent Communication From Baseline to 9 Months
Adolescent 3-month # of Relationship Topics
1.88 score on a scale
Standard Deviation 2.18
2.96 score on a scale
Standard Deviation 2.43
Change in Parent-Adolescent Communication From Baseline to 9 Months
Adolescent 9-month # of Relationship Topics
1.80 score on a scale
Standard Deviation 2.00
1.96 score on a scale
Standard Deviation 2.05
Change in Parent-Adolescent Communication From Baseline to 9 Months
Parent Baseline OFCS
40.17 score on a scale
Standard Deviation 6.98
39.33 score on a scale
Standard Deviation 5.89
Change in Parent-Adolescent Communication From Baseline to 9 Months
Parent 3-month OFCS
40.18 score on a scale
Standard Deviation 7.41
40.73 score on a scale
Standard Deviation 6.06
Change in Parent-Adolescent Communication From Baseline to 9 Months
Parent 9-month OFCS
40.55 score on a scale
Standard Deviation 6.71
40.16 score on a scale
Standard Deviation 6.80
Change in Parent-Adolescent Communication From Baseline to 9 Months
Parent Baseline PFCS
37.35 score on a scale
Standard Deviation 5.63
38.65 score on a scale
Standard Deviation 5.68
Change in Parent-Adolescent Communication From Baseline to 9 Months
Parent 3-month PFCS
37.52 score on a scale
Standard Deviation 5.58
39.25 score on a scale
Standard Deviation 5.29
Change in Parent-Adolescent Communication From Baseline to 9 Months
Parent 9-month PFCS
38.06 score on a scale
Standard Deviation 6.13
40.20 score on a scale
Standard Deviation 5.05
Change in Parent-Adolescent Communication From Baseline to 9 Months
Parent Baseline # of Relationship Topics
4.32 score on a scale
Standard Deviation 1.83
4.20 score on a scale
Standard Deviation 1.79
Change in Parent-Adolescent Communication From Baseline to 9 Months
Parent 3-month # of Relationship Topics
3.36 score on a scale
Standard Deviation 2.05
4.56 score on a scale
Standard Deviation 1.65
Change in Parent-Adolescent Communication From Baseline to 9 Months
Parent 9-month # of Relationship Topics
3.70 score on a scale
Standard Deviation 2.06
3.57 score on a scale
Standard Deviation 1.89

SECONDARY outcome

Timeframe: Baseline, 3 months, 9 months

Population: COMPLETER ANALYSIS

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.

Outcome measures

Outcome measures
Measure
Waitlist Control
n=60 Participants
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
n=54 Participants
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.
Change in Emotion Regulation Skills Baseline to 9 Months
Baseline ERBS
2.04 score on a scale
Standard Deviation 0.82
2.18 score on a scale
Standard Deviation 0.82
Change in Emotion Regulation Skills Baseline to 9 Months
3-month ERBS
2.01 score on a scale
Standard Deviation 0.83
2.18 score on a scale
Standard Deviation 0.92
Change in Emotion Regulation Skills Baseline to 9 Months
9-month ERBS
1.86 score on a scale
Standard Deviation 0.70
2.21 score on a scale
Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline, 3 months, 9 months

Population: COMPLETER ANALYSIS

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.

Outcome measures

Outcome measures
Measure
Waitlist Control
n=60 Participants
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
n=54 Participants
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.
Change in Distress Tolerance From Baseline to 9 Months
Baseline BIRD
256.68 seconds
Standard Deviation 78.70
251.19 seconds
Standard Deviation 78.05
Change in Distress Tolerance From Baseline to 9 Months
3-month BIRD
240.98 seconds
Standard Deviation 80.06
230.66 seconds
Standard Deviation 84.04
Change in Distress Tolerance From Baseline to 9 Months
9-month BIRD
227.17 seconds
Standard Deviation 84.39
243.14 seconds
Standard Deviation 78.35

Adverse Events

Waitlist Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Project STRONG

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

DR. CHRISTIE RIZZO

NORTHEASTERN UNIVERSITY

Phone: (617) 373-2486

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place