Clinical trial NCT05910502: Project AFECT (Autism Family Empowerment Coaching and Training Program)
Official title: Autism Family Empowerment Coaching and Training Program (AFECT): Evaluating a Parent Coaching and Family Navigation Program for New Autism Spectrum Disorder Diagnosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 1. Waitlist control
2. Participants in the control group will be offered the opportunity to participate in the intervention group if the child has not received any autism treatments 6 months after enrollment in this study.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-Efficacy
timeFrame: From enrollment to the end of intervention at 6 months
measure: Stress Level
timeFrame: From enrollment to the end of intervention at 6 months
Secondary outcomes:
measure: Child's Language Development
timeFrame: From enrollment to the end of intervention at 6 months
measure: Wait time to autism treatments
timeFrame: From enrollment to the end of intervention at 6 months
measure: Wait time to early intervention/special education
timeFrame: From enrollment to the end of intervention at 6 months
Other outcomes:
Locations:
city: Atherton
country: United States
facility: Gardner Packard Children's Health Center
state: California
city: Sunnyvale
country: United States
facility: Stanford Medicine Children's Health
state: California
Study officials:
affiliation: Stanford University
name: Heidi Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: