Project AFECT (Autism Family Empowerment Coaching and Training Program)

NCT05910502 | Active Not Recruiting

• 1 other identifier: IRB#69103
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

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

Keywords

Parent Coaching; Family Navigation; Parent Training; Parent Stress; Parent Self-Efficacy; Service Navigation

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  From enrollment to the end of intervention at 6 months

Secondary Outcomes (3)

• Child's Language Development

  From enrollment to the end of intervention at 6 months

• Access to autism treatments

  From enrollment to the end of intervention at 6 months

• Access to early intervention/special education

  From enrollment to the end of intervention at 6 months

Study Arms (1)

Coaching Group

EXPERIMENTAL

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

Behavioral: Autism Family Empowerment Coaching and Training Program

Interventions

Autism Family Empowerment Coaching and Training Program 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.

Also known as: Project AFECT

Coaching Group

Eligibility Criteria

• Age: 12 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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).

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (2)

Gardner Packard Children's Health Center

Atherton, California, 94027, United States

Location

Stanford Medicine Children's Health

Sunnyvale, California, 94087, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Child Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Heidi Feldman, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Developmental and Behavioral Pediatrics, Stanford University School of Medicine

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: September 19, 2023
• Primary Completion: December 12, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)