NCT05185453

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 24, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 23, 2024

Completed
Last Updated

August 23, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

December 22, 2021

Results QC Date

June 26, 2024

Last Update Submit

August 20, 2024

Conditions

Keywords

social networkssocial supportviolence prevention

Outcome Measures

Primary Outcomes (2)

  • 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)

Secondary Outcomes (1)

  • Participant Satisfaction With Weekly Session Content Assessed by Researcher-generated Likert-scale Items

    end of program (12 weeks)

Other Outcomes (6)

  • Change in Social Network Composition

    Baseline, end of program (12 weeks)

  • Change in Violence Perpetration

    Baseline, end of program (12 weeks)

  • Change in Violence Victimization

    Baseline, end of program (12 weeks)

  • +3 more other outcomes

Study Arms (2)

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.

Behavioral: Strengthening Connections for Change

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.

Behavioral: Job Readiness Training

Interventions

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.

Strengthening Connections for Change

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.

Job Readiness Training

Eligibility Criteria

Age13 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipants 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.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Youth:
  • Participants must be ages 13-17 (inclusive)
  • Participants must speak English
  • Adults
  • Participants must be ages 18 or older
  • Participants must speak English

You may not qualify if:

  • Youth:
  • Not ages 13-17 (inclusive)
  • Do not speak English
  • Adults
  • Less than 18 years of age
  • Do not speak English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Dr. Alison Culyba
Organization
University of Pittsburgh

Study Officials

  • Alison Culyba, MD PhD MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 11, 2022

Study Start

May 24, 2022

Primary Completion

July 11, 2023

Study Completion

July 11, 2023

Last Updated

August 23, 2024

Results First Posted

August 23, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

The research team will not make individual participant data (IPD) available to other researchers.

Locations