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NCT Number: NCT07500363

Improving Caregiver Engagement in Early Interventions

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).

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Key information

Age range

12 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis MIND Institute

Sacramento, California, 95817, United States

Location status: Recruiting

Location contact

Yue Yu, PhD

CONTACT

[email protected]

916-734-8412

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Providers' eligibility criteria

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

Caregiver/Child Dyads eligibility criteria

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

Treatment and study plan

FANS-EI

Behavioral

Social support related text messages delivered to supporters and caregivers; asynchronized educational materials for supporters.

Early Intervention

Behavioral

Treatment as usual provided by community-based autism early intervention agencies

Primary outcomes

  1. Parent Participatory Engagement Measure

    Time frame: Weekly for 6 months

    The 5-item Parent Participatory Engagement Measure (PPEM) examines caregiver comfort with, engagement and participation in the intervention.

Secondary outcomes

  1. Caregiver Buy-In to EI

    Time frame: baseline, 6 months

    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)

  2. Parenting Sense of Competence Scale

    Time frame: Baseline, 6 months

    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

  3. Social Support Index

    Time frame: Baseline, 6 months

    A 17-item measure of caregiver-reported social support, rated on a 5-point Likert scale (1=Strongly Disagree to 5=Strongly Agree).

  4. Acceptability of Intervention Measure

    Time frame: 6 months

    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).

  5. Intervention Appropriateness Measure

    Time frame: 6 months

    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. Feasibility of Intervention Measure

    Time frame: 6 months

    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).

Other outcomes

  1. Coaching Practices Rating Scales

    Time frame: Baseline, 2nd and 4th months, 6 months

    This measures practitioner use of coaching practices on a 5-point scale (1 = None of time to 5 = all of the time).

  2. Frequency of contact

    Time frame: Baseline, weekly until exit at 6 months

    Frequency of contact between the supporter and the caregiver

  3. Vineland Adaptive Behavior Scales-3

    Time frame: Baseline, 6 months

    This measures adaptive behaviors on a 3-point Likert scale (0 = never, 1 = sometimes, 2 = usually or often).

  4. MacArthur-Bates Communicative Development Inventory

    Time frame: Baseline, 6 months

    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.

  5. Qualitative Interview

    Time frame: 6 months

    Conduct semi-structured interviews with providers, caregivers, and supporters to examine the implementation outcomes.

  6. Usability of Intervention Measure

    Time frame: 6 months

    The 3-item Usability of Intervention Measure will be used to measure usability of FANS-EI using open ended questions.

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 30, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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