Parent Coaching for Autism

(AFECT Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help parents of young children newly diagnosed with autism better understand the condition and find suitable treatments. It examines whether coaching and support can reduce parental stress, boost confidence, and enhance children's language skills. Parents with children aged 1 to 5 who are Hispanic/Latino or Black/African-American, have Medi-Cal, and live in certain California counties may qualify. Participants will complete surveys and work with a coach while researchers compare different groups to assess the effects of the Autism Family Empowerment Coaching and Training Program. As an unphased study, this trial offers families a unique opportunity to gain valuable support and insights into autism management.

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 prior data suggests that this parent coaching program is safe for families?

Research shows that the Autism Family Empowerment Coaching and Training Program, known as Project AFECT, assists parents after their child receives an autism diagnosis. The program provides parent coaching and family support.

Regarding safety, no reports of negative effects exist because the program involves coaching and guidance, not medication or medical procedures. This makes it a low-risk option for participants. Since it is not a drug or medical treatment, concerns like side effects or allergic reactions do not apply.

The program aims to reduce stress for parents and boost their confidence, indicating it is generally well-received. Participants typically engage in surveys and work with a coach to gain the full benefits of the program. This focus on empowerment and support suggests that the program is safe and designed to positively impact families. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Autism Family Empowerment Coaching and Training Program because it offers a fresh approach to supporting families of children with autism. Unlike traditional therapies that often focus directly on the child, this program empowers parents through coaching, giving them the tools and confidence to support their child's development. By involving parents more directly, the program aims to create a more supportive and effective environment for the child at home, potentially leading to better outcomes. This approach not only enhances parental skills but also strengthens the family unit, offering a holistic benefits that current options may not fully address.

What evidence suggests that Project AFECT is effective for autism?

Research has shown that parent coaching programs like Project AFECT, which participants in this trial will receive, effectively support families with children who have autism. Studies have found that these programs lower parents' stress and increase their confidence by offering guidance and support. Evidence also indicates that these programs facilitate access to early intervention services, reducing wait times for autism treatments. Additionally, early findings suggest that children whose parents receive coaching may develop better language skills. Overall, Project AFECT combines parent coaching and family guidance to improve outcomes for both parents and children. ^{1 2 3 5 6}

Who Is on the Research Team?

Heidi Feldman, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Coaching Group Experimental Treatment 1 Intervention

Coaching Group will receive Project AFECT intervention, in addition to 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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05910502

Project AFECT (Autism Family Empowerment Coaching ... This is a prospective clinical effectiveness study of Project AFECT, an intervention combining parent coaching and family navigation. Parents who meet inclusion ...

2. ctv.veeva.com ctv.veeva.com/study/project-afect-autism-family-empowerment-coaching-and-training-program

Project AFECT (Autism Family Empowerment Coaching and ... This is a prospective clinical effectiveness study of Project AFECT, an intervention combining parent coaching and family navigation. Parents ...

3. withpower.com withpower.com/trial/phase-autistic-disorder-5-2023-62fb3

Parent Coaching for Autism (AFECT Trial) The parent coach training program for toddlers at risk for autism spectrum disorder showed effective fidelity scores among early intervention providers, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317650/

Effectiveness of a Parent Empowerment Program for ... This study evaluated the effectiveness of a parent empowerment program combining parental training and motivational interviewing to support ...

5. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/p/NCT05910502.html

Project AFECT (Autism Family Empowerment Coaching and ... * Work with Project AFECT Coach. Researchers will compare control and intervention groups to see if Project AFECT leads to improved parent and child outcomes.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05910502/project-afect-autism-family-empowerment-coaching-and-training-program

Project AFECT (Autism Family Empowerment Coaching ... This is a prospective clinical effectiveness study of Project AFECT, an intervention combining parent coaching and family navigation. Parents ...