Project AFECT (Autism Family Empowerment Coaching and Training Program)

NCT ID: NCT05910502

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-19

Study Completion Date

2026-12-31

Brief Summary

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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

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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

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Autism Spectrum Disorder Autism Autism Spectrum Disorders Autistic Disorder Autistic Spectrum Disorder Autistic Spectrum Disorders Autistic Disorders Spectrum

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Coaching Group

Coaching Group will receive Project AFECT intervention, in addition to treatment as usual.

Group Type EXPERIMENTAL

Autism Family Empowerment Coaching and Training Program

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Project AFECT

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

60 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Heidi M. Feldman

Professor of Developmental and Behavioral Pediatrics, Stanford University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heidi Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Gardner Packard Children's Health Center

Atherton, California, United States

Site Status

Stanford Medicine Children's Health

Sunnyvale, California, United States

Site Status

Countries

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United States

Other Identifiers

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IRB#69103

Identifier Type: -

Identifier Source: org_study_id

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