NCT04029220

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

July 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

February 18, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

August 17, 2022

Status Verified

August 1, 2022

Enrollment Period

2.9 years

First QC Date

July 17, 2019

Last Update Submit

August 15, 2022

Conditions

Mental Disorder, ChildMental HealthFamily Health

Keywords

Patient NavigationMental Health Services

Outcome Measures

Primary Outcomes (1)

  • Change in Services Assessment for Children and Adolescents (SACA)

    The Brief Form of the Services Assessment for Children and Adolescents (SACA) obtains for each service setting, information about the specific type of service used, provider, duration and frequency of use, and reason for use. Questions are asked not only about child involvement but those aspects of the service that require parent involvement.

    Baseline, 3 months and 6 months

Secondary Outcomes (11)

  • Working Alliance Inventory - Short Form (WAI-S): Change is being assessed

    Baseline, 3 months, 6 months

  • Family Journey Assessment (FJA): Change is being assessed

    Baseline, 3 months, 6 months

  • Family Empowerment Scale (FES): Change is being assessed

    Baseline, 3 months, 6 months

  • Social Support Questionnaire (SSQ): Change is being assessed

    Baseline, 3 months, 6 months

  • The Revised Short Form of the Caregiver Strain Questionnaire (CSQ):Change is being assessed

    Baseline, 3 months, 6 months

  • +6 more secondary outcomes

Study Arms (2)

Parent Peer Navigation (PPN) by Family Run Organization

EXPERIMENTAL

In this arm, families receive PPN services from a trained provider with lived experience whose role is 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 is no longer involved. PPN providers use the foundational competencies and skills to educate, inform and support families who are just entering the child-serving systems due to emerging behavioral health issues of their child.

Behavioral: Parent Peer Navigation

Resources provided by Family Support Organization

ACTIVE COMPARATOR

The active comparator is service provided by Family Support Organizations (FSOs), which provide information and resources for families about disabilities, special education and other services as well as workshops and parent support groups. Unlike PPN services, FSO staff members are not "veteran caregivers" of a child with mental health challenges, do not provide personalized service delivery, do not provide a comprehensive assessment of family needs, and do not prepare families to make use of services through support for their initial and continued involvement in them. Finally, whereas PPNs participate in comprehensive training and coaching, training for FSO staff tends to be more general and consists primarily of being aware of local resources to which families may be referred.

Behavioral: Parent Peer Navigation

Interventions

Parent Peer NavigationBEHAVIORAL

Parent Peer Navigation (PPN) is implemented by trained providers with lived experience, who are supported by training and coaching protocols. The role of PPN provider is to engage caregivers in necessary treatment for their children and prepare them to independently navigate the child serving system, community-based resources, and ongoing opportunities for support. PPN providers will support families who are just entering he child-serving systems for 6 months on a weekly basis during which they will: help link families with formal and informal supports; instill confidence and coping skills; assist in the development of goals and crisis plans; and serve as an advocate for resolution of issues. Also, the PPN provider helps the family to learn to navigate systems and advocate for their needs, prepares families for meetings and treatment sessions, helps identify ways for parents to practice self-care; and promotes family choice and shared decision making.

Parent Peer Navigation (PPN) by Family Run OrganizationResources provided by Family Support Organization

Eligibility Criteria

Age1 Year - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Colorado School of Medicine

Aurora, Colorado, 80045-7106, United States

RECRUITING

Oregon Family Support Network

Salem, Oregon, 97302, United States

NOT YET RECRUITING

Allegheny Family Network

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Uplift Wyoming

Cheyenne, Wyoming, 82001, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30382742BACKGROUND

MeSH Terms

Conditions

Neurodevelopmental DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehavior

Study Officials

  • Bruno J. Anthony, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Anthony

CONTACT

1-800-624-6553bruno.anthony@ucdenver.edu

Tennyson Dahlman, BA

CONTACT

1-800-624-6553tennyson.dahlman@cuanchutz.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Staff supporting on-line data collection will not be aware of arm participation
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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..
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 23, 2019

Study Start

February 18, 2020

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

August 17, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(4)