Violence in AdolescenceNCT05185453

Strengthening Adolescent-Adult Networks to Reduce Youth Violence

A study testing Strengthening Connections for Change and Job Readiness Training in people with Violence in Adolescence and Social Interaction, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 years and olderHealthy volunteers can take part
Conditions the study is for: Violence in Adolescence, Social Interaction, Coping Skills
What is being tested?: Strengthening Connections for Change and Job Readiness Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteUnited States
Study dates: 24 May 2022to 11 Jul 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Read the 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.

Conditions: Violence in Adolescence, Social Interaction, Coping Skills, Adolescent Behavior
Being tested: Strengthening Connections for Change, Job Readiness Training
Keywords: social networks, social support, violence prevention
Medical subject headings: Adolescent Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Strengthening Connections for ChangeBehavioural
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.
Job Readiness TrainingBehavioural
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.

Study groups in NCT05185453
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Job Readiness Training

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: end of program (12 weeks)

Secondary outcomes (1)

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.
Measured: end of program (12 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 202211 Jul 2023

First posted11 Jan 2022
Study start24 May 2022
Primary completion11 Jul 2023
Study completion11 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Violence in AdolescenceStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model 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. 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).
Masking: None (open label)
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05185453
Sponsor's protocol ID: STUDY21030140
Other IDs: 1K23HD098277-01
Status last verified: Jun 2024
First submitted: 22 Dec 2021
Last updated: 23 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The research team will not make individual participant data (IPD) available to other researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Violence in Adolescence trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Strengthening Adolescent-Adult Networks to Reduce Youth Violence
ClinicalTrials.gov ID: NCT05185453
Acronym / sponsor ID: STUDY21030140
Conditions: Violence in Adolescence, Social Interaction, Coping Skills, Adolescent Behavior
Keywords: social networks, social support, violence prevention
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 24 May 2022 (actual)
Primary completion: 11 Jul 2023 (actual)
Study completion: 11 Jul 2023 (actual)
First posted: 11 Jan 2022 (actual)
Results: Posted 23 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model 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. 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).

Arm	Type	Receives
Strengthening Connections for Change	Experimental	Behavioral: Strengthening Connections for ChangeStrengthening 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	Behavioral: Job Readiness TrainingJob 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.

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Strengthening Connections for ChangeStrengthening 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.	Behavioural	Strengthening Connections for Change
Job Readiness TrainingJob 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.	Behavioural	Job Readiness Training

Primary outcome

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.
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.

1 secondary outcome

Participant Satisfaction With Weekly Session Content Assessed by Researcher-generated Likert-scale Items
Time frame: end of program (12 weeks)

Results and safety

Results posted to the registry on 23 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Strengthening Connections for Change	45	32
Job Readiness Training	29	26

Primary outcome: Participant Attendance

Time frame: through intervention completion, 12 weeks. Number. Unit: proportion of sessions attended

Measure	Strengthening Connections for Change--YOUTH n = 34	Strengthening Connections for Change--ADULTS n = 11	Job Readiness Training--YOUTH n = 29
Value	0.62	0.49	0.71

Primary outcome: Participant Overall Satisfaction With Curriculum Content and Format Assessed by Researcher-generated Likert-scale Items

Time frame: end of program (12 weeks). Mean (Standard Deviation). Unit: score on a scale

Measure	Strengthening Connections for Change--YOUTH n = 34	Strengthening Connections for Change--ADULTS n = 11
Value	3.47 (1.00)	4.07 (0.70)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Strengthening Connections for Change--YOUTH	0 of 34 (0%)	0 of 34 (0%)	0 of 34
Strengthening Connections for Change--ADULTS	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Job Readiness Training	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. The research team will not make individual participant data (IPD) available to other researchers.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alison Culyba, MD PhD MPH principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Attendance (time frame: through intervention completion, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05185453.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.