Improving Caregiver Engagement in Early Interventions

July 13, 2026 updated by: University of California, Davis

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Weekly for 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
baseline, 6 months
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
Baseline, 6 months
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).
Baseline, 6 months
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).
6 months
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 months
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).
6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Baseline, 2nd and 4th months, 6 months
Frequency of contact
Time Frame: Baseline, weekly until exit at 6 months
Frequency of contact between the supporter and the caregiver
Baseline, weekly until exit at 6 months
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).
Baseline, 6 months
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.
Baseline, 6 months
Qualitative Interview
Time Frame: 6 months
Conduct semi-structured interviews with providers, caregivers, and supporters to examine the implementation outcomes.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Davis

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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