Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism

Autism Spectrum Disorder Clinical Trial

— ATTAIN NAV  

Official title:

Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement With Mental Health Services for Youth With Autism

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05344378
• Other study ID #: 200147
• Secondary ID: 1R34MH120190-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This project, Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement with Mental Health Services for Youth with Autism (ATTAIN NAV) is focused on adapting and implementing family navigation in primary care settings to help accelerate and facilitate engagement in mental health and community services for children with autism and their families.

Description:

Efficient and effective access to and engagement with evidence-based mental health (MH) services for children with autism spectrum disorder (ASD) is critically needed but requires a tailored approach. This project is critical in establishing integrated and sustainable local capacity to provide evidence-based MH care for children (ages 4-16 years) with ASD+ (i.e., children with ASD and co-occurring psychiatric disorders). Specifically, the overarching goal of this mixed methods proposal is to collaboratively adapt Family Navigation (FN) content, navigator activities and training for children with ASD+, identify and design technology enhancements to FN that will target key mechanisms to impact implementation, service and clinical outcomes, key interrelated outcomes for implementation research. The research team will leverage existing partnerships with primary care practices and lay health worker organizations in San Diego County to establish a community-academic partnership that will guide adaptations to FN for children with ASD+ (Aim 1), co-design of the navigator-facing technology enhancements (Aim 2) and trial the adapted and technology-enhanced FN (Aim 3).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 190
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 16 Years

Eligibility

Inclusion Criteria:

Inclusion Criteria for Primary Care Providers

1. Employed as staff at participating primary care practice

2. Experience providing primary care to children with ASD

3. For Aim 3 only: Has at least five eligible children on current caseload

Inclusion Criteria for Child/Caregiver Participants (Aim 3 only)

1. Child age 4-16 years.

2. Child has a diagnosis of autism spectrum disorder documented in medical chart.

3. Child is receiving primary care at a participating primary care practice.

4. Child screens in the clinically significant range on the Pediatric Symptom Checklist at baseline.

5. Speaks English or Spanish.

6. Caregiver of an eligible child.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Behavioral Health
• Implementation Science
• Mental Health

Intervention

Behavioral:
• ATTAIN NAV Technology-Enhanced Family Navigation Model
The purpose of ATTAIN NAV is to test the impact of family navigation in multiple primary care clinics in Southern California for children with autism who have additional mental health needs. Family navigation includes: screening and behavioral health referral, supporting access to behavioral health services, engaging in evidence-based treatment, monitoring to achieve family goals, family strengthening, and connecting to concrete resources.

Locations

Country	Name	City	State
United States	UCSD	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Kaiser Permanente, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Broder-Fingert S, Stadnick NA, Hickey E, Goupil J, Diaz Lindhart Y, Feinberg E. Defining the core components of Family Navigation for autism spectrum disorder. Autism. 2020 Feb;24(2):526-530. doi: 10.1177/1362361319864079. Epub 2019 Jul 16. — View Citation

Stadnick NA, Martinez K, Aarons GA, Lee DA, Van Cleave J, Brookman-Frazee L. Pediatric Primary Care Perspectives on Integrated Mental Health Care for Autism. Acad Pediatr. 2020 Nov-Dec;20(8):1140-1147. doi: 10.1016/j.acap.2020.03.006. Epub 2020 Mar 20. — View Citation

Stadnick NA, Penalosa MG, Martinez K, Brookman-Frazee L, Gizzo DP, Sahms T, Kuelbs CL, Aarons GA. Pre-Implementation Organizational Environment Associated with Pediatric Integrated Care Readiness in Primary Care. Evid Based Pract Child Adolesc Ment Health. 2022;7(1):5-11. doi: 10.1080/23794925.2021.1875344. Epub 2021 Feb 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of Intervention Measure (AIM)	4-item questionnaire measure adapted for the ATTAIN NAV study to assess acceptability of the overall adapted FN intervention. Four-item measures of implementation outcomes that are considered indicators of implementation success. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Higher scores indicate a better outcome.	Distributed at study completion, an average of 1 year.
Primary	Feasibility of Intervention Measure (FIM)	4-item questionnaire measure adapted for the ATTAIN NAV study to assess feasibility of the overall adapted FN intervention. Four-item measures of implementation outcomes that are considered indicators of implementation success. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Higher scores indicate a better outcome.	Distributed at study completion, an average of 1 year.
Primary	Appropriateness of Intervention Measure (AIM)	4-item questionnaire measure adapted for the ATTAIN NAV study to assess appropriateness of the overall adapted FN intervention. Four-item measures of implementation outcomes that are considered indicators of implementation success. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scoring Instructions: Scales can be created for each measure by averaging responses. Scale values range from 1 to 5. No items need to be reverse coded. Higher scores indicate a better outcome.	Distributed at study completion, an average of 1 year.
Primary	the Navigation Satisfaction Tool (NAVSAT)	22 item questionnaire assess satisfaction with the relationship with the navigator and with the referred services to which the navigator facilitated access. Response scale: 1= Extremely Dissatisfied 2=Dissatisfied 3=Fairly Dissatisfied 4= Not dissatisfied nor satisfied 5= Fairly Satisfied 6= Satisfied 7= Extremely Satisfied. Higher scores indicate a better outcome.	Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
Primary	Navigator Fidelity	The investigators will adapt fidelity procedures (observational and self-report) from the navigator training curriculum used in MOST. Fidelity will be defined as demonstrating mastery on at least 80% of all components (e.g., navigator introduces purpose of navigation during initial contact, conducts assessment on barriers to attendance of first MH appointment). Fidelity will be measured at the completion of the navigator protocol for each family.	Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
Primary	Eyberg Child Behavior Inventory (ECBI)	The ECBI is a 36-item caregiver-report measure that assesses the frequency and intensity of child behavior problems. It has shown sensitivity to change over time. There are two scores: an Intensity score (frequency of behaviors) and a Problem (number of challenging behaviors) score. Both are converted into t-scores (M =50; SD=10). Scoring: on a 1-7 scale: How often does this occur with your child? ranging from (1) Never to (7) Always. There is a secondary scale that asks is this a problem for you? Yes/No.	Measured at the start and completion of family navigation services for each family, approximately week 0 and 4 months after enrolling.
Primary	Parent Activation Measure for Developmental Disabilities (PAM-DD)	This 13-item measure will be used to examine changes in caregiver knowledge, skill and confidence to manage their child. The PAM-DD also includes a rating scale of perceived caregiver activation level. The scale ranges from (1) strongly disagree to (4) strongly agree. A higher score indicates a more positive rating.	Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.
Primary	Parent Participation Engagement Measure	A 5-item parent-report measure of active caregiver engagement in youth mental health services. Each item assesses the frequency that a parent engaged in a participation behavior (e.g., asked questions, provided input, agreed with the plan) during a MH appointment on a 5-point scale ranging from (1) Not at all to (5) very much. To additionally capture family engagement, the investigators will track the number of contacts between the navigator and family during the interval between the PCP referral to navigation and the first completed MH appointment.	Measured at the completion of family navigation services for each family, approximately 4 months after enrolling.