Project AFECT (Autism Family Empowerment Coaching and Training Program)

Autism Spectrum Disorder Clinical Trial

— AFECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910502
• Other study ID #: IRB#69103
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: October 2023
• Source: Stanford University
• Contact: Ingrid Lin, MD
• Phone: 650-725-0555
• Email: ingridyl[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Participants in the control group will receive treatment as usual. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 60 Months

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Gardner Packard Children's Health Center	Atherton	California
United States	Stanford Medicine Children's Health	Sunnyvale	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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).	From enrollment to the end of intervention at 6 months
Secondary	Wait time to autism treatments	Time from initial autism diagnosis to start of applied behavior analysis (ABA) therapy	From enrollment to the end of intervention at 6 months
Secondary	Wait time 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)	From enrollment to the end of intervention at 6 months