Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HD098277-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
This pilot community-partnered cluster-randomized trial will examine the feasibility and acceptability of a social network-based youth violence prevention program called Strengthening Connections for Change for youth ages 13-17 and their key adult supports.
This pilot community-partnered cluster-randomized trial will examine the feasibility and acceptability of a social network-based youth violence prevention program called Strengthening Connections for Change for youth ages 13-17 and their key adult supports. Set in four lower resource Pittsburgh, Pennsylvania neighborhoods, this study brings together youth ages 13-17 and their self-identified key adult supports to focus on leadership, strengthening intergenerational networks, community engagement, and violence prevention.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strengthening Connections for Change | Experimental | Strengthening Connections for Change uses a group discussion format with activities that explore identity, adolescent-adult relationships, social networks, and community engagement. Youth invite their self-identified key adult supports to jointly participate in programming and curriculum includes youth-focused, adult-focused and jointly focused activities designed to build leadership skills, enhance intergenerational networks, challenge attitudes towards violence and retaliation, and reduce violence involvement. Through 12 sessions (2 hours/session) delivered weekly, Strengthening Connections offers leadership development coupled with strengths-based youth violence prevention programming. |
|
| Job Readiness Training | Active Comparator | Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth. Participants receive a 12 session job readiness training with linkages to businesses and employment opportunities. Discussions include a wide range of topics related to career exploration and job readiness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strengthening Connections for Change | Behavioral | Strengthening Connections for Change is a 12-session curriculum designed to strengthen adolescent-adult support networks, build leadership skills, foster community engagement, and challenge attitudes and behaviors that foster violence involvement. During the program, youth ages 13-17 years invite their self-identified key adult supports to jointly participate in programming including youth-focused, adult-focused and jointly focused activities. Towards the end of programming participants design and carry out a community project to strengthen intergenerational connections and promote community engagement. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Attendance | Attendance recorded at beginning and end of each session. Calculated as a proportion of total number of sessions attended (possible session attended #: 0-12 for youth participants and 0-9 for adult participants) using the following method (# youth at session 1 + # youth at session 2 + …)/(# of youth participants x12 sessions) and (# adults at session 1 + # adults at session 2 + …)/(# of adult participants x9 sessions). The possible proportion attended ranges from 0-1. | through intervention completion, 12 weeks |
| Participant Overall Satisfaction With Curriculum Content and Format Assessed by Researcher-generated Likert-scale Items | At the end of the program, participants will be asked about how satisfied they were overall with the topics discussed and format of the program using 5-point Likert scale items. Means score will be calculated across the items (possible range: 1-5; higher score means higher satisfaction). This data was collected for the Strengthening Connections for change intervention groups only. | end of program (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction With Weekly Session Content Assessed by Researcher-generated Likert-scale Items | At the end of each of the 12 sessions, participants will be asked about how satisfied they were with the topics discussed for that session using 5-point Likert scale items. A mean score will be calculated by taking the average of the responses on session forms completed by each youth across all time points (i.e., Session 1 Mean Score + Session 2 Mean Score + Session 3 Mean score +.../ 12 sessions) (possible range: 1-5; higher score means higher satisfaction). This data was collected for the Strengthening Connections for change intervention groups only. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Social Network Composition | Participants will complete an abbreviated social network survey that asks them to identify key sources of emotional and instrumental support, and to characterize the nature of these relationships (network size, network density, mean link strength). | Baseline, end of program (12 weeks) |
Inclusion Criteria:
Youth:
Adults
Exclusion Criteria:
Youth:
Adults
Participants that self report any self-representation of gender identity to include, but not limited to, male, female, trans-male, trans-female, nonbinary, or gender non conforming.
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alison Culyba, MD PhD MPH | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
The research team will not make individual participant data (IPD) available to other researchers.
Not provided
Not provided
Not provided
Not provided
Not provided
We partnered with youth-serving agencies to assist with recruitment through community settings. During program session #1, youth in the intervention group were asked to identify a key adult support in family, school, or community to participate in the program. The study team reached out to the adult to facilitate enrollment. Of the 34 youth, 11 identified an adult who consented to enroll in the study.
| ID | Title | Description |
|---|---|---|
| FG000 | Strengthening Connections for Change | Strengthening Connections for Change uses a group discussion format with activities that explore identity, adolescent-adult relationships, social networks, and community engagement. Youth invite their self-identified key adult supports to jointly participate in programming and curriculum includes youth-focused, adult-focused and jointly focused activities designed to build leadership skills, enhance intergenerational networks, challenge attitudes towards violence and retaliation, and reduce violence involvement. Through 12 sessions (2 hours/session) delivered weekly, Strengthening Connections offers leadership development coupled with strengths-based youth violence prevention programming. Strengthening Connections for Change: Strengthening Connections for Change is a 12-session curriculum designed to strengthen adolescent-adult support networks, build leadership skills, foster community engagement, and challenge attitudes and behaviors that foster violence involvement. During the program, youth ages 13-17 years invite their self-identified key adult supports to jointly participate in programming including youth-focused, adult-focused and jointly focused activities. Towards the end of programming participants design and carry out a community project to strengthen intergenerational connections and promote community engagement. |
| FG001 | Job Readiness Training | Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth. Participants receive a 12 session job readiness training with linkages to businesses and employment opportunities. Discussions include a wide range of topics related to career exploration and job readiness. Job Readiness Training: Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two neighborhoods were randomized to the Strengthening Connections for Change (SCC) intervention and two neighborhoods were randomized to Job Readiness Training. In the 2 SCC neighborhoods, both youth and adults were recruited. In the 2 Job Readiness Training neighborhoods only youth were recruited.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Strengthening Connections for Change--Youth | Strengthening Connections for Change uses a group discussion format with activities that explore identity, adolescent-adult relationships, social networks, and community engagement. Youth invite their self-identified key adult supports to jointly participate in programming and curriculum includes youth-focused, adult-focused and jointly focused activities designed to build leadership skills, enhance intergenerational networks, challenge attitudes towards violence and retaliation, and reduce violence involvement. Through 12 sessions (2 hours/session) delivered weekly, Strengthening Connections offers leadership development coupled with strengths-based youth violence prevention programming. Strengthening Connections for Change: Strengthening Connections for Change is a 12-session curriculum designed to strengthen adolescent-adult support networks, build leadership skills, foster community engagement, and challenge attitudes and behaviors that foster violence involvement. During the program, youth ages 13-17 years invite their self-identified key adult supports to jointly participate in programming including youth-focused, adult-focused and jointly focused activities. Towards the end of programming participants design and carry out a community project to strengthen intergenerational connections and promote community engagement. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Participant Attendance | Attendance recorded at beginning and end of each session. Calculated as a proportion of total number of sessions attended (possible session attended #: 0-12 for youth participants and 0-9 for adult participants) using the following method (# youth at session 1 + # youth at session 2 + …)/(# of youth participants x12 sessions) and (# adults at session 1 + # adults at session 2 + …)/(# of adult participants x9 sessions). The possible proportion attended ranges from 0-1. | Posted | Number | proportion of sessions attended | through intervention completion, 12 weeks | neighborhoods | neighborhoods |
|
For each participant, adverse event data was recorded for the duration of their involvement as a research participant. Data was collected across the full study from enrollment of the first participant to study completion (up to 12 weeks).
We follow the definitions of adverse events as outlined by the clinicaltrials.gov definitions and University of Pittsburgh Human Subjects Research Protection Office, and any questions we have about specific events, we review with a representative from this office.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Strengthening Connections for Change--YOUTH | Strengthening Connections for Change uses a group discussion format with activities that explore identity, adolescent-adult relationships, social networks, and community engagement. Youth invite their self-identified key adult supports to jointly participate in programming and curriculum includes youth-focused, adult-focused and jointly focused activities designed to build leadership skills, enhance intergenerational networks, challenge attitudes towards violence and retaliation, and reduce violence involvement. Through 12 sessions (2 hours/session) delivered weekly, Strengthening Connections offers leadership development coupled with strengths-based youth violence prevention programming. Strengthening Connections for Change: Strengthening Connections for Change is a 12-session curriculum designed to strengthen adolescent-adult support networks, build leadership skills, foster community engagement, and challenge attitudes and behaviors that foster violence involvement. During the program, youth ages 13-17 years invite their self-identified key adult supports to jointly participate in programming including youth-focused, adult-focused and jointly focused activities. Towards the end of programming participants design and carry out a community project to strengthen intergenerational connections and promote community engagement. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Culyba | University of Pittsburgh | 412-692-6056 | alison.culyba@chp.edu |
Not provided
| 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 | May 1, 2022 | May 29, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
This pilot community-partnered cluster-randomized trial will examine the feasibility and acceptability of a social network-based youth violence prevention program called Strengthening Connections for Change for youth ages 13-17 and their key adult supports. The study will be located in four lower resource Pittsburgh, Pennsylvania neighborhoods ('clusters') randomized to receive either the Strengthening Connections for Change program (i.e. intervention neighborhoods, n=2) or to a job skills training program (i.e. control neighborhoods, n=2).
Not provided
Not provided
Not provided
Not provided
|
| Job Readiness Training | Behavioral | Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth. |
|
| end of program (12 weeks) |
| Change in Violence Perpetration |
Summary score of past 30-day youth violence perpetration adapted from the Aggressive Behavior--SAGE Baseline survey (9 items, each measured on a 5-point frequency scale from 0 times to 7 or more times). Violence perpetration items will be added to create a summary violence perpetration score with 1 point for each response of at least 1 time (possible range: 0-9; lower score indicates better outcome). |
| Baseline, end of program (12 weeks) |
| Change in Violence Victimization | Summary score of past 30-day youth violence victimization adapted from the Victimization--Problem Behavior Frequency Scale (9 items, each measured on a 5-point frequency scale from 0 times to 7 or more times). Violence victimization items will be added to create a summary violence victimization score with 1 point for each response of at least 1 time (possible range: 0-9; lower score indicates better outcome). | Baseline, end of program (12 weeks) |
| Change in Attitudes Towards Violence | Modified from the Children's Perception of Environmental Violence Scale, 6 items assessed on 5-point Likert scale, calculated as a mean score (possible range 1-5; lower score indicates better outcome). | Baseline, end of program (12 weeks) |
| Change in Coping | Modified from the Healthy Pathways Child-Report Scales: Active Coping Scale, 7 items assessed on 5-point Likert scale, calculated as a mean score (possible range 1-5; higher score indicates better outcome). | Baseline, end of program (12 weeks) |
| Change in Future Orientation | Modified from the California Healthy Kids Survey, 7 items assessed on 5-point Likert scale, calculated as a mean score (possible range 1-5; higher score indicates better outcome). | Baseline, end of program (12 weeks) |
| BG001 | Strengthening Connections for Change--Adults | During the Strengthening Connections for Change program, youth invite their self-identified key adult supports to jointly participate in programming including youth-focused, adult-focused and jointly focused activities. |
| BG002 | Job Readiness Training--Youth | Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth. Participants receive a 12 session job readiness training with linkages to businesses and employment opportunities. Discussions include a wide range of topics related to career exploration and job readiness. Job Readiness Training: Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Self-identified gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Strengthening Connections for Change--ADULTS | Strengthening Connections for Change uses a group discussion format with activities that explore identity, adolescent-adult relationships, social networks, and community engagement. Youth invite their self-identified key adult supports to jointly participate in programming and curriculum includes youth-focused, adult-focused and jointly focused activities designed to build leadership skills, enhance intergenerational networks, challenge attitudes towards violence and retaliation, and reduce violence involvement. Through 12 sessions (2 hours/session) delivered weekly, Strengthening Connections offers leadership development coupled with strengths-based youth violence prevention programming. Strengthening Connections for Change: Strengthening Connections for Change is a 12-session curriculum designed to strengthen adolescent-adult support networks, build leadership skills, foster community engagement, and challenge attitudes and behaviors that foster violence involvement. During the program, youth ages 13-17 years invite their self-identified key adult supports to jointly participate in programming including youth-focused, adult-focused and jointly focused activities. Towards the end of programming participants design and carry out a community project to strengthen intergenerational connections and promote community engagement. |
| OG002 | Job Readiness Training--YOUTH | Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth. Participants receive a 12 session job readiness training with linkages to businesses and employment opportunities. Discussions include a wide range of topics related to career exploration and job readiness. Job Readiness Training: Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth. |
|
|
| Primary | Participant Overall Satisfaction With Curriculum Content and Format Assessed by Researcher-generated Likert-scale Items | At the end of the program, participants will be asked about how satisfied they were overall with the topics discussed and format of the program using 5-point Likert scale items. Means score will be calculated across the items (possible range: 1-5; higher score means higher satisfaction). This data was collected for the Strengthening Connections for change intervention groups only. | Posted | Mean | Standard Deviation | score on a scale | end of program (12 weeks) | neighborhoods | neighborhoods |
|
|
|
| Secondary | Participant Satisfaction With Weekly Session Content Assessed by Researcher-generated Likert-scale Items | At the end of each of the 12 sessions, participants will be asked about how satisfied they were with the topics discussed for that session using 5-point Likert scale items. A mean score will be calculated by taking the average of the responses on session forms completed by each youth across all time points (i.e., Session 1 Mean Score + Session 2 Mean Score + Session 3 Mean score +.../ 12 sessions) (possible range: 1-5; higher score means higher satisfaction). This data was collected for the Strengthening Connections for change intervention groups only. | Posted | Mean | Standard Deviation | score on a scale | end of program (12 weeks) | neighborhoods | neighborhoods |
|
|
|
| Other Pre-specified | Change in Social Network Composition | Participants will complete an abbreviated social network survey that asks them to identify key sources of emotional and instrumental support, and to characterize the nature of these relationships (network size, network density, mean link strength). | Not Posted | Baseline, end of program (12 weeks) | Participants |
| Other Pre-specified | Change in Violence Perpetration | Summary score of past 30-day youth violence perpetration adapted from the Aggressive Behavior--SAGE Baseline survey (9 items, each measured on a 5-point frequency scale from 0 times to 7 or more times). Violence perpetration items will be added to create a summary violence perpetration score with 1 point for each response of at least 1 time (possible range: 0-9; lower score indicates better outcome). | Not Posted | Baseline, end of program (12 weeks) | Participants |
| Other Pre-specified | Change in Violence Victimization | Summary score of past 30-day youth violence victimization adapted from the Victimization--Problem Behavior Frequency Scale (9 items, each measured on a 5-point frequency scale from 0 times to 7 or more times). Violence victimization items will be added to create a summary violence victimization score with 1 point for each response of at least 1 time (possible range: 0-9; lower score indicates better outcome). | Not Posted | Baseline, end of program (12 weeks) | Participants |
| Other Pre-specified | Change in Attitudes Towards Violence | Modified from the Children's Perception of Environmental Violence Scale, 6 items assessed on 5-point Likert scale, calculated as a mean score (possible range 1-5; lower score indicates better outcome). | Not Posted | Baseline, end of program (12 weeks) | Participants |
| Other Pre-specified | Change in Coping | Modified from the Healthy Pathways Child-Report Scales: Active Coping Scale, 7 items assessed on 5-point Likert scale, calculated as a mean score (possible range 1-5; higher score indicates better outcome). | Not Posted | Baseline, end of program (12 weeks) | Participants |
| Other Pre-specified | Change in Future Orientation | Modified from the California Healthy Kids Survey, 7 items assessed on 5-point Likert scale, calculated as a mean score (possible range 1-5; higher score indicates better outcome). | Not Posted | Baseline, end of program (12 weeks) | Participants |
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Strengthening Connections for Change--ADULTS | Strengthening Connections for Change uses a group discussion format with activities that explore identity, adolescent-adult relationships, social networks, and community engagement. Youth invite their self-identified key adult supports to jointly participate in programming and curriculum includes youth-focused, adult-focused and jointly focused activities designed to build leadership skills, enhance intergenerational networks, challenge attitudes towards violence and retaliation, and reduce violence involvement. Through 12 sessions (2 hours/session) delivered weekly, Strengthening Connections offers leadership development coupled with strengths-based youth violence prevention programming. Strengthening Connections for Change: Strengthening Connections for Change is a 12-session curriculum designed to strengthen adolescent-adult support networks, build leadership skills, foster community engagement, and challenge attitudes and behaviors that foster violence involvement. During the program, youth ages 13-17 years invite their self-identified key adult supports to jointly participate in programming including youth-focused, adult-focused and jointly focused activities. Towards the end of programming participants design and carry out a community project to strengthen intergenerational connections and promote community engagement. | 0 | 11 | 0 | 11 | 0 | 11 |
| EG002 | Job Readiness Training | Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth. Participants receive a 12 session job readiness training with linkages to businesses and employment opportunities. Discussions include a wide range of topics related to career exploration and job readiness. Job Readiness Training: Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth. | 0 | 29 | 0 | 29 | 0 | 29 |
Not provided
Not provided