search
Back to results

Intervention to Enhance Coping and Help-seeking Among Youth in Foster Care

Primary Purpose

Adolescent Behavior, Psychosocial Functioning, Coping Behavior

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stronger Youth Networks and Coping (SYNC)
Sponsored by
Portland State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adolescent Behavior focused on measuring Mental health, Help-seeking, Coping, Youth, Foster care, Near-peer, Independent living

Eligibility Criteria

16 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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)

Sites / Locations

  • Portland State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Services-as-usual

Arm Description

The Intervention group receives the SYNC intervention in addition to typical child welfare services (i.e., services as usual). The SYNC intervention includes 10 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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Barriers to seeking help
Barriers to Adolescent Seeking Help - Brief (BASH-B; 11 items with 7-pt response scale ranging from 1 'strongly disagree' to 7 'strongly agree agree', youth report) assesses perceived autonomy and fears related to seeking help for mental health issues. Average scores can range from 1 to 7, with higher scores indicating more (worse) barriers.
Self-efficacy and empowerment specific to mental health
Youth Efficacy/Empowerment Scale-Mental Health (MH) (23 items with 5-pt response scale ranging from 1 'Always or almost always' to 5 'Never or almost never', youth report) assesses extent to which youth manages mental health and directs their own mental health services. Average scores can range from 1 to 5, with higher scores indicating more (better) efficacy and empowerment around mental health services.
Coping self-efficacy
Coping Self-Efficacy Scale (26 items with response scale ranging from 0 'I cannot do this at all' to 10 'Certain I can do this', youth report) assesses use of problem-focused, support-seeking, & positive reframing coping strategies. Average scores can range from 1 to 10, with higher scores indicating more (better) coping self-efficacy.

Full Information

First Posted
August 18, 2023
Last Updated
August 24, 2023
Sponsor
Portland State University
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT06019377
Brief Title
Intervention to Enhance Coping and Help-seeking Among Youth in Foster Care
Official Title
Pilot Testing an Intervention to Enhance Coping and Increase Mental Health Help-seeking Among Transition-age Youth in Foster Care
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Portland State University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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=16). 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.
Detailed Description
Young people transitioning from the foster care system have elevated risk for a range of mental health diagnoses that for many are exacerbated by psychosocial coping difficulties, sparse support networks, and service disengagement. This population is less prepared to cope with mental health challenges and more likely to have negative perspectives on help- seeking, increasing the risk of unmet treatment needs as service use rapidly declines following the exit from foster care. Our long-term goal is to 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. SYNC results from intervention development to design a novel program using evidence- based cognitive change methods, including adapting the Coping Effectiveness Training (CET) curriculum for foster youth. SYNC is designed for delivery by service providers in federally-funded Independent Living Programs (ILPs) accessed by most foster youth in the US. Initial feedback from foster youth, service providers, and our advisory panel confirmed the acceptability of SYNC curriculum topics (e.g., stress and coping, navigating services) and program strategy (e.g., groups co-facilitated by "near-peer" young adults with foster care and mental health care experience). 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 RCT of SYNC is feasible in the intended service context. Our first specific 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=16). 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. The demonstration of target engagement with initial evidence of efficacy, plus standardized intervention materials and a feasible research protocol, will prepare us for an effectiveness trial (R01) of a model that is expected to be widely transferable for implementation across the country, and one that can ultimately be adapted for other youth service settings (e.g., juvenile justice) and subgroups (e.g., lesbian, gay, bisexual, transgender, queer [LGBTQ], youth of color), expanding long-term public health impact.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Behavior, Psychosocial Functioning, Coping Behavior, Help-Seeking Behavior, Utilization, Health Care, Depression, Anxiety, Stress Disorders, Post-Traumatic, Emotion Regulation, Child Welfare
Keywords
Mental health, Help-seeking, Coping, Youth, Foster care, Near-peer, Independent living

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
10-module group psychoeducational curriculum model
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The Intervention group receives the SYNC intervention in addition to typical child welfare services (i.e., services as usual). The SYNC intervention includes 10 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.
Arm Title
Services-as-usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stronger Youth Networks and Coping (SYNC)
Intervention Description
SYNC is a 10-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.
Primary Outcome Measure Information:
Title
Cognitive control and coping flexibility
Description
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.
Time Frame
immediately after program completion, 6 months after program completion
Title
Help-seeking intentions
Description
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.
Time Frame
immediately after program completion, 6 months after program completion
Secondary Outcome Measure Information:
Title
Barriers to seeking help
Description
Barriers to Adolescent Seeking Help - Brief (BASH-B; 11 items with 7-pt response scale ranging from 1 'strongly disagree' to 7 'strongly agree agree', youth report) assesses perceived autonomy and fears related to seeking help for mental health issues. Average scores can range from 1 to 7, with higher scores indicating more (worse) barriers.
Time Frame
immediately after program completion, 6 months after program completion
Title
Self-efficacy and empowerment specific to mental health
Description
Youth Efficacy/Empowerment Scale-Mental Health (MH) (23 items with 5-pt response scale ranging from 1 'Always or almost always' to 5 'Never or almost never', youth report) assesses extent to which youth manages mental health and directs their own mental health services. Average scores can range from 1 to 5, with higher scores indicating more (better) efficacy and empowerment around mental health services.
Time Frame
immediately after program completion, 6 months after program completion
Title
Coping self-efficacy
Description
Coping Self-Efficacy Scale (26 items with response scale ranging from 0 'I cannot do this at all' to 10 'Certain I can do this', youth report) assesses use of problem-focused, support-seeking, & positive reframing coping strategies. Average scores can range from 1 to 10, with higher scores indicating more (better) coping self-efficacy.
Time Frame
immediately after program completion, 6 months after program completion
Other Pre-specified Outcome Measures:
Title
Domains for psychiatric diagnoses
Description
Diagnosis and Statistican Manual, Fifth Edition (DSM-5) Self-Rated Level 1 Cross-Cutting Symptom Measure (25 items with yes/no responses, youth report) assesses mental health domains (past 2 weeks) that are important across psychiatric diagnoses including depression, substance use, anxiety, somatic symptoms, sleep problems). Total scores can range from 0 to 25, with higher scores indicating more (worse) psychiatric symptoms.
Time Frame
immediately after program completion, 6 months after program completion
Title
Mental health service use
Description
Service Assessment for Children and Adolescents (4 items with yes/no responses, youth report) assesses service use in past 3 months: Outpatient (counseling, therapy, support group), residential treatment, inpatient hospitalization, psychotropic medication. Total scores can range from 0 to 4, with higher scores indicating more (better) service usage.
Time Frame
immediately after program completion, 6 months after program completion
Title
Depression and anxiety
Description
Revised Children's Anxiety and Depression Scale (RCADS; 25 items with 4-pt response scale ranging from 1 'Never' to 4 'Always', youth report) assesses recent anxiety and depression symptoms. Average scores can range from 1 to 4, with higher scores indicating more (worse) symptoms of anxiety and depression.
Time Frame
immediately after program completion, 6 months after program completion
Title
Post-traumatic stress disorder symptoms
Description
The Post-traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5; 17 items with 5-pt response scale ranging from 0 'Not at all' to 4 'Extremely', youth report) assess the prevalence of various post-traumatic stress disorder (PTSD) symptoms (e.g., difficulty concentrating, loss of interest in activities, trouble falling or staying asleep). Average scores can range from 1 to 5, with higher scores indicating more (worse) PTSD symptoms.
Time Frame
immediately after program completion, 6 months after program completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Blakeslee, PhD,MSW,BS
Phone
5037258389
Email
jblakes@pdx.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca A Miller, M.Ed, BA
Organizational Affiliation
Portland State University
Official's Role
Study Director
Facility Information:
Facility Name
Portland State University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Blakeslee, PhD,MSW,BS
Phone
503-725-8389
Email
jblakes@pdx.edu
First Name & Middle Initial & Last Name & Degree
Brianne H Kothari, PhD,MA,BA
First Name & Middle Initial & Last Name & Degree
Carrie J Furrer, PhD,MS,BA

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intervention to Enhance Coping and Help-seeking Among Youth in Foster Care

We'll reach out to this number within 24 hrs