NCT06019377

Brief Summary

This study will deploy a scalable secondary prevention program that leverages existing foster youth transition services to improve mental health functioning and service use before and after exiting foster care. Our short-term objective is to remotely test a group intervention called Stronger Youth Networks and Coping (SYNC) that targets cognitive schemas influencing stress responses, including mental health help-seeking and service engagement, among foster youth with behavioral health risk. SYNC aims to increase youth capacity to appraise stress and regulate emotional responses, to flexibly select adaptive coping strategies, and to promote informal and formal help-seeking as an effective coping strategy. The proposed aims will establish whether the 10-module program engages the targeted proximal mechanisms with a signal of efficacy on clinically-relevant outcomes, and whether a fully-powered randomized control trial (RCT) of SYNC is feasible in the intended service context. Our first aim is to refine our SYNC curriculum and training materials, prior to testing SYNC in a remote single-arm trial with two cohorts of 8-10 Oregon foster youth aged 16-20 (N=26). Our second aim is to conduct a remote two-arm individually-randomized group treatment trial with Oregon foster youth aged 16-20 with indicated behavioral health risk (N=80) to examine: (a) intervention group change on proximal mechanisms of coping self-efficacy and help-seeking attitudes, compared to services-as-usual at post-intervention and 6-month follow-up: and (b) association between the mechanisms and targeted outcomes, including emotional regulation, coping behaviors, mental health service use, and symptoms of depression, anxiety, and PTSD. Our third aim is to refine and standardize the intervention and research protocol for an effectiveness trial, including confirming transferability with national stakeholders.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress90%
Apr 2024Aug 2026

First Submitted

Initial submission to the registry

August 18, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

August 18, 2023

Last Update Submit

February 25, 2025

Conditions

Keywords

Mental healthHelp-seekingCopingYouthFoster careNear-peerIndependent living

Outcome Measures

Primary Outcomes (2)

  • Cognitive control and coping flexibility

    Cognitive Control and Flexibility Questionnaire (CCFQ; 18 items with 7-pt Likert-type response scale ranging from 1 'strongly disagree' to 7 'strongly agree', youth report) assesses cognitive control over emotion; and appraisal and coping flexibility. Average scores can range from 1 to 7, with higher scores indicating more (better) control and flexibility.

    immediately after program completion, 6 months after program completion

  • Help-seeking intentions

    General Help Seeking Questionnaire (22 items with 7-pt response scale ranging from 1 'Extremely unlikely' to 7 'Extremely likely', youth report) assesses intentions to seek help in the event of a personal or emotional problem and if having suicidal thoughts. Average scores can range from 1 to 7, with higher scores indicating more (better) help-seeking intentions.

    immediately after program completion, 6 months after program completion

Secondary Outcomes (3)

  • Barriers to seeking help

    immediately after program completion, 6 months after program completion

  • Self-efficacy and empowerment specific to mental health

    immediately after program completion, 6 months after program completion

  • Coping self-efficacy

    immediately after program completion, 6 months after program completion

Other Outcomes (4)

  • Domains for psychiatric diagnoses

    immediately after program completion, 6 months after program completion

  • Mental health service use

    immediately after program completion, 6 months after program completion

  • Depression and anxiety

    immediately after program completion, 6 months after program completion

  • +1 more other outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

The Intervention group receives the SYNC intervention in addition to typical child welfare services (i.e., services as usual). The SYNC intervention includes 8 weekly remote (videoconference) 90-minute sessions delivered by a facilitator and a near-peer young adult aged 20-26, both with lived experience in child welfare.

Behavioral: Stronger Youth Networks and Coping (SYNC)

Services-as-usual

NO INTERVENTION

The Services-as-usual (SAU) group receives typical child welfare services, which include ILP, or federally funded transition planning (e.g., identifying and supporting youth education and employment goals) and life skills (e.g., budgeting, renting an apartment, insurance) services typically delivered through a mix of classes, group activities, and/or individual skill-building with a paraprofessional service provider.

Interventions

SYNC is a 8-module online curriculum adapted from evidence-based cognitive change methods, including Coping Effectiveness Training (CET), co-facilitated by service providers in Independent Living Programs (ILPs; federally-funded transition skill-building services accessed by most foster youth in the US) and near-peers (have lived experience in foster care). SYNC aims to increase youth capacity to appraise stress and regulate emotional responses, to flexibly select adaptive coping strategies, and to specifically promote informal and formal help-seeking as an effective coping strategy.

Intervention

Eligibility Criteria

Age16 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Eligible to receive federally-funded transition-related services in Oregon (ages 16-20 and in foster care at least 90 days after they turned age 14),
  • Indicated behavioral health risk. Behavioral health risk is indicated by child welfare administrative indicators of lifetime behavioral health need or service involvement (DSM diagnoses, psychotropic medication, emotional-behavioral disability, congregate care/residential placement)

You may not qualify if:

  • Inability to actively participate in the intervention, including you who are: non-English speaking, significantly developmentally disabled, or where participation is otherwise contraindicated (e.g., youth is in crisis, youth is in a placement that will not allow for participation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Portland State University

Portland, Oregon, 97201, United States

RECRUITING

MeSH Terms

Conditions

Adolescent BehaviorHelp-Seeking BehaviorPatient Acceptance of Health CareDepressionAnxiety DisordersStress Disorders, Post-TraumaticEmotional RegulationPsychological Well-Being

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

BehaviorSocial BehaviorTreatment Adherence and ComplianceHealth BehaviorBehavioral SymptomsMental DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersSelf-ControlPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jennifer Blakeslee, PhD,MSW,BS

    Portland State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Blakeslee, PhD,MSW,BS

CONTACT

Rebecca A Miller, M.Ed, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 8-module group psychoeducational curriculum model
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

August 18, 2023

First Posted

August 31, 2023

Study Start

April 22, 2024

Primary Completion

March 31, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations