Strengthening Adolescent-Adult Networks to Reduce Youth Violence

August 20, 2024 updated by: Alison Culyba, University of Pittsburgh
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Youth:

  • Participants must be ages 13-17 (inclusive)
  • Participants must speak English

Adults

  • Participants must be ages 18 or older
  • Participants must speak English

Exclusion Criteria:

Youth:

  • Not ages 13-17 (inclusive)
  • Do not speak English

Adults

  • Less than 18 years of age
  • Do not speak English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Behavioral: 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.
Experimental: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participant Attendance
Time Frame: through intervention completion, 12 weeks
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
Time Frame: end of program (12 weeks)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant Satisfaction With Weekly Session Content Assessed by Researcher-generated Likert-scale Items
Time Frame: end of program (12 weeks)
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.
end of program (12 weeks)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Social Network Composition
Time Frame: Baseline, end of program (12 weeks)
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)
Change in Violence Perpetration
Time Frame: Baseline, end of program (12 weeks)
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
Time Frame: Baseline, end of program (12 weeks)
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
Time Frame: Baseline, end of program (12 weeks)
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
Time Frame: Baseline, end of program (12 weeks)
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
Time Frame: Baseline, end of program (12 weeks)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pittsburgh

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health (NIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alison Culyba, MD PhD MPH, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 24, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY21030140
  • 1K23HD098277-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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