Clinical trial NCT06019377: 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
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Portland State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-08-31
Enrollment: 106
Sex: ALL
Minimum age (years): 16
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 8-module group psychoeducational curriculum model
Primary purpose: PREVENTION

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.

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=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. 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.

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)

Primary outcomes:
measure: Cognitive control and coping flexibility
timeFrame: immediately after program completion, 6 months after program completion
measure: Help-seeking intentions
timeFrame: immediately after program completion, 6 months after program completion
Secondary outcomes:
measure: Barriers to seeking help
timeFrame: immediately after program completion, 6 months after program completion
measure: Self-efficacy and empowerment specific to mental health
timeFrame: immediately after program completion, 6 months after program completion
measure: Coping self-efficacy
timeFrame: immediately after program completion, 6 months after program completion
Other outcomes:
measure: Domains for psychiatric diagnoses
timeFrame: immediately after program completion, 6 months after program completion
measure: Mental health service use
timeFrame: immediately after program completion, 6 months after program completion
measure: Depression and anxiety
timeFrame: immediately after program completion, 6 months after program completion
measure: Post-traumatic stress disorder symptoms
timeFrame: immediately after program completion, 6 months after program completion
Locations:
city: Portland
country: United States
facility: Portland State University
state: Oregon
Study officials:
affiliation: Portland State University
name: Jennifer Blakeslee, PhD,MSW,BS
role: PRINCIPAL_INVESTIGATOR
References: