Project AFECT (Autism Family Empowerment Coaching and Training Program)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Autism Spectrum Disorder, Autism, Autism Spectrum Disorders, Autistic Disorder, Autistic Spectrum Disorder, Autistic Spectrum Disorders, Autistic Disorders Spectrum

Intervention / Treatment
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* Behavioral: Autism Family Empowerment Coaching and Training Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 60 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Waitlist control 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Treatment As Usual Group<br>This group will receive treatment as usual. | |
| Experimental: Coaching Group<br>Coaching Group will receive Project AFECT intervention, in addition to treatment as usual. | Behavioral: Autism Family Empowerment Coaching and Training Program<br>* 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.<br>* Other names: Project AFECT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Family Navigation, Parent Coaching, Parent Training, Parent Stress, Parent Self-Efficacy, Service Navigation