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Active, Not Recruiting

NCT Number: NCT05910502

Project AFECT (Autism Family Empowerment Coaching and Training Program)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

12 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gardner Packard Children's Health Center, Atherton, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

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.

Other names: Project AFECT

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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).

  2. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Autism Family Empowerment Coaching and Training Program (AFECT): Evaluating a Parent Coaching and Family Navigation Program for New Autism Spectrum Disorder Diagnosis

Acronym: AFECT

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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