Autism Spectrum DisorderAFECTNCT05910502
Project AFECT (Autism Family Empowerment Coaching and Training Program)
A study testing Autism Family Empowerment Coaching and Training Program in people with Autism Spectrum Disorder and Autism, run by Stanford University at 2 sites in United States.
Trial summary
The goal of this clinical trial is to learn about the journey of families after their child's diagnosis of autism and to help parents understand autism and get the right treatments for their child. Read more about this study
- Who is it for?
- Ages 12 to 60 months
- Conditions the study is for
- Autism Spectrum Disorder, Autism, Autism Spectrum Disorders
- What is being tested?
- Autism Family Empowerment Coaching and Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Sep 2023to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Parents of children just diagnosed with autism (with or without other diagnoses) who are:
- Age greater than 1 and up to 5 years old;
- Hispanic/Latino OR Black/African-American OR have Medi-Cal as primary health insurance; AND
- Live in one of the following counties in California (Alameda, Contra Costa, Marin, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa Clara, Santa Cruz, Solano, or Sonoma).
Who cannot join
- Non-legal guardians or foster parents who provide care to children newly diagnosed with autism.
- Parents of children without diagnosis of autism.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Gardner Packard Children's Health Center
Atherton, California, 94027
Stanford Medicine Children's Health
Sunnyvale, California, 94087
About this study
Official title: Autism Family Empowerment Coaching and Training Program (AFECT): Evaluating a Parent Coaching and Family Navigation Program for New Autism Spectrum Disorder Diagnosis
The goal of this clinical trial is to learn about the journey of families after their child's diagnosis of autism and to help parents understand autism and get the right treatments for their child. This study is for parents of children just diagnosed with autism who are:
- Age greater than 1 and up to 5 years old;
- Hispanic/Latino OR Black/African-American OR have Medi-Cal as primary health insurance; AND
- Live in one of the following counties in California (Alameda, Contra Costa, Marin, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa Clara, Santa Cruz, Solano, or Sonoma).
Read more
The main questions it aims to answer are:
- Whether parent coaching through Project AFECT leads to decreased parental stress and increased parental confidence;
- Whether family navigation through Project AFECT leads to increased number of referrals to early intervention and educational services and reduced wait times to autism treatments;
- Whether children whose parents receive Project AFECT intervention show increased language skills compared to children whose parents did not receive intervention.
Participants will be asked to:
- Complete surveys at enrollment and 3 and 6 months later.
- Work with Project AFECT Coach.
Researchers will compare control and intervention groups to see if Project AFECT leads to improved parent and child outcomes.
Read the detailed description
This is a prospective clinical effectiveness study of Project AFECT, an intervention combining parent coaching and family navigation. Parents who meet inclusion criteria will be invited to participate in this study at the time of their child's autism diagnosis at Stanford Medicine Children's Health.
In addition to treatment as usual, participants in the intervention group will be connected with Project AFECT Coaches who will provide: Coaching to (1) assure parents understand diagnosis, (2) assist parents in finding accurate, current information about autism, (3) guide parents to free online autism training resources, (4) empower parents to evaluate child's intervention plan holistically, and (5) provide emotional support to reduce stress; Navigation to (1) help family access autism treatments, and (2) connect to early intervention and educational services.
- Conditions
- Autism Spectrum Disorder, Autism, Autism Spectrum Disorders, Autistic Disorder, Autistic Spectrum Disorder, Autistic Spectrum Disorders
- Being tested
- Autism Family Empowerment Coaching and Training Program
- Keywords
- Parent Coaching, Family Navigation, Parent Training, Parent Stress, Parent Self-Efficacy, Service Navigation
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autism Family Empowerment Coaching and Training ProgramBehavioural
Also called Project AFECT
Participants in the intervention group will be connected with Project AFECT Coaches who will provide: Coaching to (1) assure parents understand diagnosis, (2) assist parents in finding accurate, current information about autism, (3) guide parents to free online autism training resources, (4) empower parents to evaluate child's intervention plan holistically, and (5) provide emotional support to reduce stress; Navigation to (1) help family access autism treatments, and (2) connect to early intervention and educational services.
| Study group | Role | What they receive |
|---|---|---|
| Coaching Group | Experimental | Coaching Group will receive Project AFECT intervention, in addition to treatment as usual. Receives: Behavioral: Autism Family Empowerment Coaching and Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Efficacy
Mean change from baseline in parental self-efficacy measured using Autism-Specific Parenting Self-Efficacy Scale (PSEaS). Overall possible scores on the scale range from 17 - 85. The higher the score, the higher the measured level of parental self-efficacy (better outcome).
Measured: From enrollment to the end of intervention at 6 months
Stress Level
Mean change from baseline in parental stress level measured using Parental Stress Scale (PSS). Overall possible scores on the scale range from 18 - 90. The higher the score, the higher the measured level of parental stress (worse outcome).
Measured: From enrollment to the end of intervention at 6 months
Secondary outcomes (3)
Child's Language Development
Scores using MacArthur-Bates Communicative Development Inventory - Words and Gestures. For comparison between groups, we will be utilizing the raw scores. Overall possible raw scores range from 0 - 396. The higher the raw score, the higher the number of words understood and produced by the child (better outcome).
Measured: From enrollment to the end of intervention at 6 months
Access to autism treatments
Time from initial autism diagnosis to start of applied behavior analysis (ABA) therapy
Measured: From enrollment to the end of intervention at 6 months
Access to early intervention/special education
Time from initial autism diagnosis to assessment for early intervention/special education and development of Individualized Family Service Plan (IFSP)/Individualized Education Program (IEP)
Measured: From enrollment to the end of intervention at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start19 Sep 2023
- Primary completion12 Dec 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi M. Feldman, Stanford University
- Investigators
- Heidi Feldman, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05910502
- Sponsor's protocol ID
- IRB#69103
- Acronym
- AFECT
- Status last verified
- Sep 2026
- First submitted
- 9 Jun 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. This study collects sensitive self-reported data on parental stress, family functioning, and child characteristics, which are inherently personal in nature. Participants were not consented for broader data sharing beyond the purposes of this specific research project, making IPD sharing inconsistent with the informed consent agreements under which data were collected. Aggregate results and findings will be made available through peer-reviewed publication.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Family Empowerment Coaching and Training Program (AFECT): Evaluating a Parent Coaching and Family Navigation Program for New Autism Spectrum Disorder Diagnosis
- ClinicalTrials.gov ID
- NCT05910502
- Acronym / sponsor ID
- AFECT / IRB#69103
- Conditions
- Autism Spectrum Disorder, Autism, Autism Spectrum Disorders, Autistic Disorder, Autistic Spectrum Disorder, Autistic Spectrum Disorders
- Keywords
- Parent Coaching, Family Navigation, Parent Training, Parent Stress, Parent Self-Efficacy, Service Navigation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 18 Jun 2023 (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 clinical trial is to learn about the journey of families after their child's diagnosis of autism and to help parents understand autism and get the right treatments for their child. This study is for parents of children just diagnosed with autism who are:
- Age greater than 1 and up to 5 years old;
- Hispanic/Latino OR Black/African-American OR have Medi-Cal as primary health insurance; AND
- Live in one of the following counties in California (Alameda, Contra Costa, Marin, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa Clara, Santa Cruz, Solano, or Sonoma).
The main questions it aims to answer are:
- Whether parent coaching through Project AFECT leads to decreased parental stress and increased parental confidence;
- Whether family navigation through Project AFECT leads to increased number of referrals to early intervention and educational services and reduced wait times to autism treatments;
- Whether children whose parents receive Project AFECT intervention show increased language skills compared to children whose parents did not receive intervention.
Participants will be asked to:
- Complete surveys at enrollment and 3 and 6 months later.
- Work with Project AFECT Coach.
Researchers will compare control and intervention groups to see if Project AFECT leads to improved parent and child outcomes.
Detailed description
This is a prospective clinical effectiveness study of Project AFECT, an intervention combining parent coaching and family navigation. Parents who meet inclusion criteria will be invited to participate in this study at the time of their child's autism diagnosis at Stanford Medicine Children's Health.
In addition to treatment as usual, participants in the intervention group will be connected with Project AFECT Coaches who will provide: Coaching to (1) assure parents understand diagnosis, (2) assist parents in finding accurate, current information about autism, (3) guide parents to free online autism training resources, (4) empower parents to evaluate child's intervention plan holistically, and (5) provide emotional support to reduce stress; Navigation to (1) help family access autism treatments, and (2) connect to early intervention and educational services.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coaching Group | Experimental | Behavioral: Autism Family Empowerment Coaching and Training ProgramCoaching Group will receive Project AFECT intervention, in addition to treatment as usual. |
Who may qualify
- Ages
- 12 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 1. Parents of children just diagnosed with autism (with or without other diagnoses) who are:
- Age greater than 1 and up to 5 years old;
- Hispanic/Latino OR Black/African-American OR have Medi-Cal as primary health insurance; AND
- Live in one of the following counties in California (Alameda, Contra Costa, Marin, Monterey, Napa, San Benito, San Francisco, San Mateo, Santa Clara, Santa Cruz, Solano, or Sonoma).
Key exclusion criteria (2 listed)
- Non-legal guardians or foster parents who provide care to children newly diagnosed with autism.
- Parents of children without diagnosis of autism.
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 |
|---|---|---|
| Autism Family Empowerment Coaching and Training ProgramAlso: Project AFECTParticipants in the intervention group will be connected with Project AFECT Coaches who will provide: Coaching to (1) assure parents understand diagnosis, (2) assist parents in finding accurate, current information about autism, (3) guide parents to free online autism training resources, (4) empower parents to evaluate child's intervention plan holistically, and (5) provide emotional support to reduce stress; Navigation to (1) help family access autism treatments, and (2) connect to early intervention and educational services. | Behavioural | Coaching Group |
Primary outcome
Self-Efficacy
Time frame: From enrollment to the end of intervention at 6 months
Mean change from baseline in parental self-efficacy measured using Autism-Specific Parenting Self-Efficacy Scale (PSEaS). Overall possible scores on the scale range from 17 - 85. The higher the score, the higher the measured level of parental self-efficacy (better outcome).
Stress Level
Time frame: From enrollment to the end of intervention at 6 months
Mean change from baseline in parental stress level measured using Parental Stress Scale (PSS). Overall possible scores on the scale range from 18 - 90. The higher the score, the higher the measured level of parental stress (worse outcome).
3 secondary outcomes
Child's Language Development
Time frame: From enrollment to the end of intervention at 6 months
Access to autism treatments
Time frame: From enrollment to the end of intervention at 6 months
Access to early intervention/special education
Time frame: From enrollment to the end of intervention at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. This study collects sensitive self-reported data on parental stress, family functioning, and child characteristics, which are inherently personal in nature. Participants were not consented for broader data sharing beyond the purposes of this specific research project, making IPD sharing inconsistent with the informed consent agreements under which data were collected. Aggregate results and findings will be made available through peer-reviewed publication.
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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. This study is not recruiting at the moment.
Heidi Feldman, MD, PhD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autism Family Empowerment Coaching and Training Program in people with Autism Spectrum Disorder and Autism, run by Stanford University at 2 sites 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?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Efficacy (time frame: From enrollment to the end of intervention at 6 months). The study lists 2 primary outcomes in all. 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 17 Sep 2026.