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Clinical Trials/NCT05910502
NCT05910502
Active, Not Recruiting
N/A

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

Stanford University2 sites in 1 country200 target enrollmentSeptember 19, 2023

Overview

Phase
N/A
Intervention
Autism Family Empowerment Coaching and Training Program
Conditions
Autism Spectrum Disorder
Sponsor
Stanford University
Enrollment
200
Locations
2
Primary Endpoint
Stress Level
Status
Active, Not Recruiting
Last Updated
3 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 19, 2023
End Date
December 31, 2026
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heidi M. Feldman

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

Stanford University

Eligibility Criteria

Inclusion Criteria

  • 1\. 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.

Arms & Interventions

Coaching Group

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

Intervention: Autism Family Empowerment Coaching and Training Program

Outcomes

Primary Outcomes

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).

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).

Secondary Outcomes

  • 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 Sites (2)

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