Clinical trial NCT04029220: Navigation and Parent Peer Support to Promote Access
Official title: Navigation and Parent Peer Support to Promote Access and Retention of Children in Mental Health Services
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Disorder, Child
Mental Health
Family Health
Keywords: Patient Navigation
Mental Health Services
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Washington
name: University of Pittsburgh
name: Uplift Wyoming
name: Allegheny Family Network
name: Family-Run Executive Director Leadership Association
name: Oregon Family Support Network
First posted: 2019-07-23
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will employ a randomized trial to provide a preliminary test of the impact of Parent Peer Navigation (PPN) on key caregiver and child outcomes. We will recruit children and families through schools and through those families contacting Family Run Organizations directly in Pennsylvania and Wyoming, who will then be referred randomly to either a (1) Family Support Organization or Service (FSO) that provides only information and referrals by staff who are not family members with lived experience or (2) one of the FROs (Allegheny Family Network in Pennsylvania or UPLIFT in Wyoming) that provides PPN by family members with lived experience..
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Nearly one in five children in the United States has a mental health problem that interferes with daily functioning and requires intervention, and yet less than 50% of children who need mental health care receive any services. Families and especially from low-income and ethnically diverse backgrounds, experience a range of barriers to engaging in services for their children including: lack of recognition of problems and knowledge of available treatments, connecting to services, trust in providers, stigma; low income and ethnically diverse populations are especially affected by these barriers. In this work, the investigators propose to carry out initial testing of a research- and theory-based model of Parent Peer Navigation services to help engage families with children with significant but pre-clinical problems in mental health services in order to prevent future poorer outcomes for children, who otherwise may never receive services, or only receive services when their mental health issues become severely debilitating for themselves and their family.

Detailed description: Parent peer navigation (PPN), provided by other caregivers who have lived experience raising a youth with mental health conditions, holds promise as a service that can aid in improving both youth and caregiver outcomes by overcoming system- and individual-level barriers to care. This proposed study will support initial testing of a research- and theory- based Parent Peer Navigation (PPN) model created by one of the nation's leading advocacy organizations for caregivers of children and youth with mental health challenges, the federally funded Family-Run Executive Directors Leadership Association. This model, called the National Parent Peer Support Practice Model (Practice Model) has an associated training program and aims to effectively engage parents/caregivers in necessary treatment for their children by helping them connect with assessment, treatment and community-based resources and prepare them to independently navigate the child serving system, community-based resources, and ongoing opportunities for support once the PPN provider is no longer involved. The Practice Model incorporates five theory- and research-based components of support: (1) information/educational, (2) instructional/skills development; (3) emotional/ affirming, (4) instrumental; and (5) advocacy. The study will focus on children in early stages of impairment as a result of mental health challenges for which prevention of further disability is possible. It will take advantage of implementation of the Practice Model through two non-profit family-run organizations (FROs) and will occur in three phases, beginning with preparatory work to develop recruitment strategies in collaboration with local schools, formalize implementation outcomes (acceptability, appropriateness, feasibility, fidelity) and other measures followed by a Feasibility Study to finalize recruitment, procedures and measurement frames. Finally, in Phase 3, the investigators will conduct a cluster randomized trial to provide a preliminary test of the impact of the Practice Model on key caregiver and child outcomes. Children who are experiencing mental health challenges but have not had exposure to formal mental health services will be identified by collaborating schools and FROs/FSOs and referred for family support. Consenting families will be randomly assigned to a treatment group who will receive PPN services based on the Practice Model from participating FROs, or a comparison group who will be referred to a Family Support Organization which provide other types of resources (e.g., referrals, information). The investigators predict that youth and parents receiving PPN will show significantly greater rates of access, engagement and retention in services as compared to the comparison group. The investigators also predict that at 6 months following PPN onset, children in the treatment group will exhibit improved social/emotional functioning and that parents in the treatment group will exhibit increased empowerment and decreased parenting stress, as compared to those in the comparison group.

Eligibility criteria: Inclusion Criteria:

PPN provider:

* Over the age of 18 years
* Has experience in providing PPN services to families
* Has lived experience of having a child with mental health challenges
* Employed by the collaborating Family Run Organization

Parents/Caregivers:

* Over the age of 18 years,
* Have a child aged 1-13 with significant mental health symptoms and impairment but who has had no formal mental health treatment

Child:

* Aged 1-13 years
* Has significant mental health symptoms and impairment
* Has had no formal mental health treatment

Exclusion Criteria:

PPN provider:

* None

Parent:

* His or her child is in crisis needing more intense levels of care
* His or her child has been living continuously with parent for less than one year

Child:

* In crisis needed more intense levels of care
* Has been living continuously with parent for less than one year

Primary outcomes:
measure: Change in Services Assessment for Children and Adolescents (SACA)
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Working Alliance Inventory - Short Form (WAI-S): Change is being assessed
timeFrame: Baseline, 3 months, 6 months
measure: Family Journey Assessment (FJA): Change is being assessed
timeFrame: Baseline, 3 months, 6 months
measure: Family Empowerment Scale (FES): Change is being assessed
timeFrame: Baseline, 3 months, 6 months
measure: Social Support Questionnaire (SSQ): Change is being assessed
timeFrame: Baseline, 3 months, 6 months
measure: The Revised Short Form of the Caregiver Strain Questionnaire (CSQ):Change is being assessed
timeFrame: Baseline, 3 months, 6 months
measure: Hope Scale: Change is being assessed
timeFrame: Baseline, 3 months, 6 months
measure: School attendance: Change is being assessed
timeFrame: Baseline, 3 months, 6 months
measure: School suspension: Change is being assessed
timeFrame: Baseline, 3 months, 6 months
measure: School expulsion: Change is being assessed
timeFrame: Baseline, 3 months, 6 months
measure: Strengths and Difficulties Questionnaire (SDQ): Change is being assessed
timeFrame: Baseline, 3 months, 6 months
measure: Youth Top Problems: Change is being assessed
timeFrame: Baseline, 3 months, 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado School of Medicine
state: Colorado
city: Salem
country: United States
facility: Oregon Family Support Network
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny Family Network
state: Pennsylvania
city: Cheyenne
country: United States
facility: Uplift Wyoming
state: Wyoming
Study officials:
affiliation: University of Colorado, Denver
name: Bruno J. Anthony, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anthony BJ, Serkin C, Kahn N, Troxel M, Shank J. Tracking progress in peer-delivered family-to-family support. Psychol Serv. 2019 Aug;16(3):388-401. doi: 10.1037/ser0000256. Epub 2018 Nov 1.