Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT05910502
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2023-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Project AFECT (Autism Family Empowerment Coaching and Training Program)
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Autism Family Empowerment Coaching and Training Program (AFECT): Evaluating a Parent Coaching and Family Navigation Program for New Autism Spectrum Disorder Diagnosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AFECT
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.
* 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: