Parent Coaching for Autism

(AFECT Trial)

Recruiting at 1 trial location

Overseen By Ingrid Lin, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-legal guardians, No autism diagnosis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

120 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Autism Family Empowerment Coaching and Training Program for autism?

Research shows that parent-mediated early interventions, which include parent coaching, can significantly improve children's cognitive abilities, social skills, and behavior, as well as boost parents' confidence and engagement in treatment. This suggests that programs like the Autism Family Empowerment Coaching and Training Program, which focus on empowering and coaching parents, may be effective in supporting children with autism. ^{1 2 3 4 5}

Is parent coaching for autism safe for families?

The studies on parent coaching for autism, such as SAFE and FAUT-E, indicate that these programs are generally safe and well-received by parents, with no increase in parental stress reported. ^{4 6 7 8 9}

How is the Autism Family Empowerment Coaching and Training Program different from other treatments for autism?

This treatment is unique because it focuses on empowering parents through coaching, teaching them techniques to improve their child's functioning, which is often underutilized in community settings. Unlike other treatments that may directly target the child, this program emphasizes parent involvement and aims to enhance parental self-efficacy and engagement. ^{1 4 5 10 11}

What is the purpose of this trial?

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.

Research Team

Heidi Feldman, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for parents of children aged 1-5, recently diagnosed with autism, who are Hispanic/Latino, Black/African-American or have Medi-Cal insurance in certain California counties. It's not for non-legal guardians or foster parents of children without an autism diagnosis.

Inclusion Criteria

Parents of children just diagnosed with autism (with or without other diagnoses) who are Hispanic/Latino OR Black/African-American OR have Medi-Cal as primary health insurance

My child, recently diagnosed with autism, is between 1 and 5 years old.

Parents of children just diagnosed with autism (with or without other diagnoses) who 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

Parents of children without diagnosis of autism

I care for a child newly diagnosed with autism, but I am not their legal guardian or foster parent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive Project AFECT intervention, including parent coaching and family navigation, in addition to treatment as usual

6 months

3 visits (virtual) at enrollment, 3 months, and 6 months

Follow-up

Participants are monitored for changes in parental stress, self-efficacy, and child's language development

4 weeks

Treatment Details

Interventions

• Autism Family Empowerment Coaching and Training Program

Trial Overview The study tests a program called Project AFECT that aims to empower and coach families after an autism diagnosis. It will assess if this coaching reduces parental stress, improves confidence, speeds up referrals to services and enhances language skills in the children.

Participant Groups

Group I: Coaching Group Experimental Treatment 1 Intervention

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

Group II: Treatment As Usual Group Active Control 1 Intervention

This group will receive treatment as usual.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

California Department of Developmental Services

Collaborator

Trials

1

Recruited

120+

Findings from Research

The parent coach training program for toddlers at risk for autism spectrum disorder showed effective fidelity scores among early intervention providers, indicating that the training was generally successful, although there was variability in performance among trainees.

Key factors for successful implementation included a supportive agency environment and readiness for change, while barriers such as time constraints and technology challenges were noted, highlighting the need for tailored support in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Coaches in Community Agencies to Support Parents of Children with Suspected Autism: Outcomes, Facilitators, and Barriers. Mirenda, P., Smith, V., Colozzo, P., et al.[2022]

Early intervention for children with autism spectrum disorder (ASD) has seen significant growth, focusing primarily on child outcomes like language acquisition, but there is a need to also consider family outcomes such as quality of life and parent self-efficacy.

Parent buy-in is crucial for the success of parent-mediated interventions, highlighting the importance of evaluating and improving family outcomes to ensure the sustainability and effectiveness of these interventions in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remembering parents in parent-mediated early intervention: An approach to examining impact on parents and families. Wainer, AL., Hepburn, S., McMahon Griffith, E.[2019]

An evaluation framework for parent education and training programs in autism spectrum disorder (ASD) was developed through a consensus-building workshop with 14 stakeholders, including experts and parents, highlighting the need for structured program selection.

Key components of the framework include themes such as 'Outcomes' (impact on parents, children, families, and communities) and 'Processes and Procedures' (focusing on accessibility and acceptability), which can help guide clinicians, researchers, and policymakers in implementing effective ASD programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing an Evaluation Framework for Parent Education and Training in Autism Spectrum Disorder: Results of a Multi-stakeholder Process. Dawson-Squibb, JJ., de Vries, PJ.[2020]

Parent-mediated early interventions for children with autism spectrum disorder (ASD) can significantly enhance children's cognitive, social, and behavioral skills, but community-based clinicians often do not utilize parent coaching effectively.

This study aims to develop and test a toolkit of strategies to improve the use of parent coaching by early intervention clinicians, with initial phases focusing on understanding current practices and barriers, ultimately leading to a pilot test with nine clinicians and parent-child dyads.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent empowerment and coaching in early intervention: study protocol for a feasibility study. Pellecchia, M., Beidas, RS., Mandell, DS., et al.[2022]

In a study involving 18 children with Autism Spectrum Disorder, those who received 12 weeks of Parental Coaching showed significantly greater improvements in developmental skills compared to a control group that did not receive any specialized training.

The Parental Coaching, based on the Early Start Denver Model, enhanced not only the children's skills in areas like communication and social interaction but also improved the quality of parent-child interactions, suggesting it as an effective early intervention strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of early parental coaching in the autism spectrum disorder. Malucelli, ERS., Antoniuk, SA., Carvalho, NO.[2022]

The feasibility study involved 34 families of children with autism and demonstrated that the Systemic Autism-related Family Enabling (SAFE) intervention is acceptable and can be effectively delivered by NHS staff, with 88% retention of families throughout the study.

Families receiving SAFE showed a significant reduction in scores on the primary outcome measure (SCORE-15), indicating positive changes in family dynamics and suggesting that SAFE could be a beneficial treatment for families of children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAFE, a new therapeutic intervention for families of children with autism: a randomised controlled feasibility trial. McKenzie, R., Dallos, R., Stedmon, J., et al.[2021]

The SAFE (Systemic Autism-related Family Enabling) intervention is a new family therapy designed specifically for families of children with autism, aiming to provide comprehensive support and improve mental health outcomes for family members.

This study will assess the feasibility of a randomized controlled trial involving families of children aged 3-16 years, focusing on various outcomes such as child behavior, parent-child attachment, and mental health, with data collected at baseline and 32 weeks post-allocation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAFE, a new therapeutic intervention for families of children with autism: study protocol for a feasibility randomised controlled trial. McKenzie, R., Dallos, R., Stedmon, J., et al.[2023]

A psychoeducational parent training program for parents of autistic children showed high satisfaction among participants and positive effects on parent-child interactions after a 3-month follow-up.

The training, which included education on autism and child management skills, involved 24 parents and was conducted over three sessions, indicating its potential effectiveness in improving family dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development and evaluation of a psychoeducational parent group training program for families with autistic children]. Probst, P.[2014]

The FAUT-E parent training program significantly improved children's behavior, as evidenced by a medium effect size on the Aberrant Behavior Checklist after the intervention and at a follow-up three months later, indicating its efficacy in managing behaviors associated with autism spectrum disorder.

The training was easy to implement and did not increase parental stress, suggesting it is a safe and practical option for parents of children newly diagnosed with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Post Effects of the Psychoeducational, Autism-Specific Parent Training FAUT-E. Medda, JE., Kitzerow, J., Schlitt, S., et al.[2021]

Clinicians working with families of young autistic children showed varying intentions to use different core components of parent coaching, with the strongest intention to demonstrate intervention strategies to parents.

The study found that psychological factors like attitudes and self-efficacy significantly influenced clinicians' intentions to use specific coaching components, suggesting that tailored implementation strategies could enhance the effectiveness of parent coaching interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician Intentions to use the Components of Parent Coaching Within Community Early Intervention Systems. Lawson, GM., Mandell, DS., Tomczuk, L., et al.[2023]

A qualitative analysis involving interviews and focus groups with 26 community providers revealed that policies and monitoring significantly influence the likelihood of offering parent coaching to families of Medicaid-enrolled autistic children.

Logistical challenges and provider perceptions of parent readiness also play crucial roles in the decision-making process, suggesting that improving these factors could enhance the equitable delivery of parent coaching services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that influence clinical decisions about offering parent coaching for autistic youth served within the Medicaid system. Straiton, D., Frost, K., Ingersoll, B.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Training Coaches in Community Agencies to Support Parents of Children with Suspected Autism: Outcomes, Facilitators, and Barriers. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Remembering parents in parent-mediated early intervention: An approach to examining impact on parents and families. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Developing an Evaluation Framework for Parent Education and Training in Autism Spectrum Disorder: Results of a Multi-stakeholder Process. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Parent empowerment and coaching in early intervention: study protocol for a feasibility study. [2022]

5. Brazil pubmed.ncbi.nlm.nih.gov

The effectiveness of early parental coaching in the autism spectrum disorder. [2022]

6. England pubmed.ncbi.nlm.nih.gov

SAFE, a new therapeutic intervention for families of children with autism: a randomised controlled feasibility trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

SAFE, a new therapeutic intervention for families of children with autism: study protocol for a feasibility randomised controlled trial. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

[Development and evaluation of a psychoeducational parent group training program for families with autistic children]. [2014]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Pre-Post Effects of the Psychoeducational, Autism-Specific Parent Training FAUT-E. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Clinician Intentions to use the Components of Parent Coaching Within Community Early Intervention Systems. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Factors that influence clinical decisions about offering parent coaching for autistic youth served within the Medicaid system. [2023]