Improving Caregiver Engagement in Early Interventions

Improving Caregiver Engagement in Early Interventions for Autistic Children Using a Mobile Health Approach

The goal of this study is to test the effectiveness of the FANS-EI program in supporting caregiver engagement in caregiver-mediated early interventions for young children with autism. This study also examines caregiver-perceived social support and self-efficacy and FANS-EI implementation outcomes (feasibility, acceptability, appropriateness).

Study Overview

• Status: Not yet recruiting
• Conditions: Autism
• Intervention / Treatment: Behavioral: Early Intervention; Behavioral: FANS-EI

Detailed Description

Caregiver involvement in early intervention (EI) goal setting and intervention delivery aligns with Part C of the Individuals with Disabilities Education Act (IDEA) guidelines. Active participation from caregivers significantly influences intervention adherence and ultimately affects child outcomes. When caregivers struggle with obtaining a diagnosis and early intervention services, low caregiver engagement can further exacerbate these challenges. In fact, the attrition rate for parent-mediated early interventions for autism ranges from 35% to 62%. Therefore, it is crucial to develop effective strategies for supporting caregiver engagement in autism early intervention. This study aims to examine the effectiveness of a social-support enhancement program, called Family/Friend Network Support for Early Intervention (FANS-EI), designed to improve caregiver engagement in community-based autism EI. This program has been adapted in collaboration with community partners from a text-based program that has successfully increased engagement and patient outcomes in diabetes treatment. Families of toddlers diagnosed with autism or a high likelihood of autism, will either receive EI as usual or FANS-EI plus EI. FANS-EI utilizes a strengths-based approach, leveraging existing family and friend support networks. Supporters, alongside caregivers, will receive information about autism or social communication development, along with text messages from the research team. These messages are designed to foster interactions between supporters and caregivers, providing emotional, informational, and educational support. The project will examine caregiver-perceived social support, self-efficacy, and implementation outcomes. Ultimately, the goal is to enhance caregiver engagement, maximizing the benefits of early interventions for both caregivers and their autistic children. This project would help further the knowledge of improving caregiver engagement in community-partnered research while addressing the persistent challenges in service utilization and child outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis MIND Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Providers' eligibility criteria

1. currently providing early intervention services, including a caregiver-coaching component
2. having at least 1 child in the autism service classification on their caseload.

Caregiver/Child Dyads eligibility criteria

1. child is 12-60 months of age at the time of enrollment
2. child has a diagnosis or high likelihood of autism
3. a family/friend supporter of the caregiver is willing to be part of the study
4. caregivers and supporters speak English

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as usual; Families receive early intervention as usual	Behavioral: Early Intervention; Treatment as usual provided by community-based autism early intervention agencies
Experimental: FANS-EI; FANS-EI supporters and caregivers will receive text messages from the research team three times a week. The messages to supporters mirror the caregiver messages and will include educational/motivational messages. Supporter will receive asynchronized general educational materials about autism (including characteristics of autism, understanding child's behaviors, etc.). Supporters will have the option, but will not be required, to attend EI sessions with the family if the family agrees.	Behavioral: FANS-EI; Social support related text messages delivered to supporters and caregivers; asynchronized educational materials for supporters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent Participatory Engagement Measure	The 5-item Parent Participatory Engagement Measure (PPEM) examines caregiver comfort with, engagement and participation in the intervention.	Weekly for 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Buy-In to EI	The extent to which caregivers value the changes called for by the EI, believe the EI is good for their child, and believe that the EI creates positive change in their child) on a 6-point Likert scale (1 = Strongly Disagree to 6 = Strongly Agree)	baseline, 6 months
Parenting Sense of Competence Scale	A 17-item caregiver self-report questionnaire measures the degree to which caregivers feel competent and confident in parenting their children (i.e., efficacy) and their satisfaction with parenting. Items are rated on a 6-point Likert scale	Baseline, 6 months
Social Support Index	A 17-item measure of caregiver-reported social support, rated on a 5-point Likert scale (1=Strongly Disagree to 5=Strongly Agree).	Baseline, 6 months
Acceptability of Intervention Measure	The 5-item Acceptability of Intervention Measure (AIM) will be used to measure acceptability of FANS-EI on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).	6 months
Intervention Appropriateness Measure	The 4-item Intervention Appropriateness Measure (IAM) will be used to measure appropriateness of FANS-EI on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).	6 months
Feasibility of Intervention Measure	The 4-item Feasibility of Intervention Measure (FIM) will be used to measure feasibility of FANS-EI on a 5-point Likert scale (1 = completely disagree to 5 = completely agree).	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coaching Practices Rating Scales	This measures practitioner use of coaching practices on a 5-point scale (1 = None of time to 5 = all of the time).	Baseline, 2nd and 4th months, 6 months
Frequency of contact	Frequency of contact between the supporter and the caregiver	Baseline, weekly until exit at 6 months
Vineland Adaptive Behavior Scales-3	This measures adaptive behaviors on a 3-point Likert scale (0 = never, 1 = sometimes, 2 = usually or often).	Baseline, 6 months
MacArthur-Bates Communicative Development Inventory	MacArthur-Bates Communicative Development Inventory (CDI) assesses caregiver-reported communicative development in young children (8 - 37 months), including vocabulary, gesture, and emergence and expansion of grammatical features.	Baseline, 6 months
Qualitative Interview	Conduct semi-structured interviews with providers, caregivers, and supporters to examine the implementation outcomes.	6 months
Usability of Intervention Measure	The 3-item Usability of Intervention Measure will be used to measure usability of FANS-EI using open ended questions.	6 months

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): March 30, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: mobile health; social support; Early Intervention; Caregiver Mediated Interventions; caregiver engagement
• Additional Relevant MeSH Terms: Autism Spectrum Disorder; Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Early Intervention, Educational
• Other Study ID Numbers: K23MH141316 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No