Project AFECT (Autism Family Empowerment Coaching and Training Program) (AFECT)

January 2, 2026 updated by: Heidi M. Feldman, Stanford University

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).

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • 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
      • Atherton, California, United States, 94027
        • Gardner Packard Children's Health Center
      • Sunnyvale, California, United States, 94087
        • Stanford Medicine Children's Health

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

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1. Parents of children just diagnosed with autism (with or without other diagnoses) who are:

  1. Age greater than 1 and up to 5 years old;
  2. Hispanic/Latino OR Black/African-American OR have Medi-Cal as primary health insurance; AND
  3. 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).

Exclusion Criteria:

  • Non-legal guardians or foster parents who provide care to children newly diagnosed with autism.
  • Parents of children without diagnosis of autism.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coaching Group
Coaching Group will receive Project AFECT intervention, in addition to treatment as usual.
Behavioral: Autism Family Empowerment Coaching and Training Program
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.
Other Names:
  • Project AFECT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From enrollment to the end of intervention at 6 months
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).
From enrollment to the end of intervention at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child's Language Development
Time Frame: From enrollment to the end of intervention at 6 months
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).
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
Time from initial autism diagnosis to start of applied behavior analysis (ABA) therapy
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
Time from initial autism diagnosis to assessment for early intervention/special education and development of Individualized Family Service Plan (IFSP)/Individualized Education Program (IEP)
From enrollment to the end of intervention at 6 months

Collaborators and Investigators

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

Sponsor

Stanford University

Collaborators

California Department of Developmental Services

Investigators

  • Principal Investigator: Heidi Feldman, MD, PhD, Stanford University

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)

September 19, 2023

Primary Completion (Actual)

December 12, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#69103

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After conclusion of this study and publication of the main findings, de-identified data will be placed in a public repository.

IPD Sharing Time Frame

June 30, 2026 to June 30, 2031

IPD Sharing Access Criteria

To be determined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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