AutismNCT07500363
Improving Caregiver Engagement in Early Interventions
A study testing FANS-EI and Early Intervention in people with Autism, run by University of California, Davis at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Autism
- What is being tested?
- FANS-EI and Early Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Davis MIND Institute
Sacramento, California, 95817
Yue Yu, PhD, 916-734-8412, eeyu@health.ucdavis.edu
About this study
Official title: 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).
Read the 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.
- Conditions
- Autism
- Being tested
- FANS-EI, Early Intervention
- Keywords
- Early Intervention, Caregiver Mediated Interventions, caregiver engagement, mobile health, social support
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FANS-EIBehavioural
Social support related text messages delivered to supporters and caregivers; asynchronized educational materials for supporters.
Early InterventionBehavioural
Treatment as usual provided by community-based autism early intervention agencies
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Families receive early intervention as usual Receives: Behavioral: Early Intervention |
| FANS-EI | Experimental | 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. Receives: Behavioral: FANS-EI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent Participatory Engagement Measure
The 5-item Parent Participatory Engagement Measure (PPEM) examines caregiver comfort with, engagement and participation in the intervention.
Measured: Weekly for 6 months
Secondary outcomes (6)
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)
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start25 Mar 2026
- Primary completionApr 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500363
- Sponsor's protocol ID
- K23MH141316
- Other IDs
- K23MH141316
- Status last verified
- Jul 2026
- First submitted
- 9 Mar 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Caregiver Engagement in Early Interventions for Autistic Children Using a Mobile Health Approach
- ClinicalTrials.gov ID
- NCT07500363
- Acronym / sponsor ID
- K23MH141316
- Conditions
- Autism
- Keywords
- Early Intervention, Caregiver Mediated Interventions, caregiver engagement, mobile health, social support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Behavioral: Early InterventionFamilies receive early intervention as usual |
| FANS-EI | Experimental | Behavioral: FANS-EIFANS-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. |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FANS-EISocial support related text messages delivered to supporters and caregivers; asynchronized educational materials for supporters. | Behavioural | FANS-EI |
| Early InterventionTreatment as usual provided by community-based autism early intervention agencies | Behavioural | Treatment as usual |
Primary outcome
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.
6 secondary outcomes
Caregiver Buy-In to EI
Time frame: baseline, 6 months
Parenting Sense of Competence Scale
Time frame: Baseline, 6 months
Social Support Index
Time frame: Baseline, 6 months
Acceptability of Intervention Measure
Time frame: 6 months
Intervention Appropriateness Measure
Time frame: 6 months
Feasibility of Intervention Measure
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of California, Davis MIND Institute
Sacramento, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FANS-EI and Early Intervention in people with Autism, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent Participatory Engagement Measure (time frame: Weekly for 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.