Telehealth Parent Coaching for Autism

Overseen By Rachel Reetzke, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Disqualifiers: Non-English, Foster care, others

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

Compensation: Varies

Number of Visits: 24

Duration: 12 weeks

188 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young children with autism or social communication delays improve their social-communication skills through parent coaching. It compares two coaching methods: one delivered in-person and the other via telehealth, to determine if the online approach is equally effective. The trial seeks children diagnosed with autism or notable social communication delays who can walk independently, among other specific criteria. Families living within 40 miles of a Kennedy Krieger Institute site, whose child uses some intentional nonverbal or verbal communication daily, may find this a good fit. Participants will receive coaching over 8-12 weeks, with two sessions each week. As an unphased trial, this study offers families a chance to contribute to important research that could enhance future interventions for children with autism.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that telehealth parent coaching is safe for young children with ASD or social communication delays?

In previous studies, families found telehealth parent coaching easy to handle. Research has shown that using Naturalistic Developmental Behavioral Interventions (NDBIs) through telehealth effectively supports young children with autism. No serious problems have been reported with this approach.

Similarly, in-person coaching for parents, using the same NDBI methods, proved safe and effective. A study with 126 families showed that children made meaningful progress without major safety concerns. Both telehealth and in-person coaching aim to help parents safely support their child's communication skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two innovative coaching methods for parents of toddlers with autism spectrum disorder (ASD) or social communication delays. Unlike traditional in-person therapies that require frequent clinic visits, this trial includes Telehealth Parent Coaching (TC), where trained coaches join families remotely via a secure platform, offering flexibility and convenience. Additionally, both the in-person and telehealth approaches employ the NDBI (Naturalistic Developmental Behavioral Interventions) strategy, which is integrated into daily routines, making it easier for families to incorporate these therapeutic techniques into everyday life. By comparing these methods, researchers hope to determine the most effective way to support parental involvement in enhancing their children's social-communication skills.

What evidence suggests that this trial's treatments could be effective for improving social-communication symptoms in young children with ASD?

Research has shown that both online (telehealth) and face-to-face parent coaching can improve social and communication skills in young children with autism. In this trial, participants will join either the Telehealth Parent Coaching (TC) arm or the In-person Coaching (IPC) arm. One study found that online coaching helps parents use everyday activities to enhance their child's communication. These methods have been well-received and have benefited young children with autism. Similarly, face-to-face coaching using the same strategies has also improved children's communication skills. Both approaches aim to empower parents to support their child's development, suggesting that online coaching could be as effective as in-person sessions. ^{2 3 6 7 8}

Who Is on the Research Team?

Rebecca Landa, PhD

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Rachel Reetzke, PhD

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Are You a Good Fit for This Trial?

This trial is for young children aged 18-33 months with mild-to-moderate Autism Spectrum Disorder (ASD), as confirmed by specific diagnostic tools. They should not have other neurological, genetic, or severe sensory-motor conditions and must be able to walk and communicate intentionally. The family must speak English, live within 30 miles of the study center, and not receive more than 15 hours of treatment per week.

Inclusion Criteria

I have been diagnosed with Autism Spectrum Disorder by a clinician.

My child meets the criteria for ASD based on ADOS.

Gestational age of 36-42 weeks

Exclusion Criteria

My caregiver will not wear a mask during visits.

Child lives in foster care

I am currently undergoing more than 15 hours of treatment per week.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either telehealth or in-person parent coaching sessions to improve social-communication skills in children with ASD

12 weeks

24 sessions (2 per week)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Early Achievements- Parent Coaching Intervention

Trial Overview The study tests if parent coaching for ASD via telehealth is just as effective as in-person coaching. It focuses on improving core social-communication skills in toddlers through a method called Early Achievements-Parent Coaching Intervention delivered remotely.

How Is the Trial Designed?

Group I: In-person Coaching(IPC) Active Control 1 Intervention

A family-centered, collaborative coaching approach, Practice-Based Coaching (Snyder et al., 2015), will be used. Coaches will use an NDBI coaching curriculum to support parents in targeting child social-communication skills during interactions with their toddlers with ASD or social communication delays. The duration of the coaching period is 8-12 weeks with sessions 2 times per week. Parents will be coached to implement NDBI strategies during daily routines with their young child with ASD following the coach and parent NDBI manuals developed in the primary principal investigator's lab. Coaching will be delivered in families' homes by trained study coaches to support parent implementation of NDBI strategies during daily life activities with their toddler with ASD or social communication delays.

Group II: Telehealth Parent Coaching (TC) Active Control 1 Intervention

A family-centered, collaborative coaching approach, Practice-Based Coaching (Snyder et al., 2015), will be used. Coaches will use an NDBI coaching curriculum to support parents in targeting the child social-communication skills during interactions with their toddlers with ASD or social communication delays. The duration of the coaching period is 8-12 weeks with 2 sessions per week. Parents will be coached to implement NDBI strategies during daily routines with their young child with ASD or social communication delays following the coach and parent NDBI manuals developed in the primary principal investigator's lab. Trained study coaches will join families in their homes remotely via Kennedy Krieger Institute's secure Zoom password-protected account to provide coaching.

Who Is Running the Clinical Trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Lead Sponsor

Trials

93

Recruited

25,200+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Johns Hopkins Bloomberg School of Public Health

Collaborator

Trials

441

Recruited

2,157,000+

Published Research Related to This Trial

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]

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]

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]

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]

In a study of 25 early intervention sessions for children with autism, providers showed low overall use of effective parent coaching techniques, indicating a need for improvement in training.

When coaching was provided, it primarily involved limited strategies like collaboration and in-vivo feedback, suggesting that targeted training on specific coaching components could enhance the effectiveness of parent-mediated interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent Coaching in Early Intervention for Autism Spectrum Disorder: A Brief Report. Pellecchia, M., Mandell, DS., Beidas, RS., et al.[2023]

Telehealth can effectively train parents in naturalistic teaching strategies to enhance communication skills in children with autism, as demonstrated in a study with five parent-child dyads.

Parents achieved high fidelity in training and reported positive experiences, while children showed variable improvements in communication and increased positive affect, making this approach a cost-effective alternative to traditional training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a telehealth platform on ABA-based parent training targeting social communication in children with autism spectrum disorder. Ferguson, J., Dounavi, K., Craig, EA.[2022]

The two-tiered Parent Early Start Denver Model (P-ESDM) intervention showed that all participating parents improved their use of ESDM strategies after group coaching, indicating the effectiveness of parent-led interventions for young autistic children.

Children exhibited positive changes in engagement, imitation, and communication skills, with significant relationships found between how well parents implemented ESDM strategies and the children's developmental outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a Two-Tiered Parent Coaching Intervention for Young Autistic Children Using the Early Start Denver Model. van Noorden, LE., Sigafoos, J., Waddington, HL.[2022]

The study demonstrated that telehealth can effectively support parents in implementing communication interventions for young children with neurodevelopmental disorders, specifically autism spectrum disorders and Rett syndrome.

All three children in the study successfully acquired targeted communication skills through parent-implemented functional communication training, highlighting the potential of remote coaching in enhancing early communication development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication Intervention for Young Children with Severe Neurodevelopmental Disabilities Via Telehealth. Simacek, J., Dimian, AF., McComas, JJ.[2019]

A study involving 13 families showed that parent training in the Naturalistic Developmental Behavioral Intervention, Project ImPACT, is feasible and positively received in community settings.

Parents reported finding value in their involvement in the intervention, perceiving benefits for their children, which highlights the importance of parent engagement in early autism interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent perceptions of an adapted evidence-based practice for toddlers with autism in a community setting. Stahmer, AC., Brookman-Frazee, L., Rieth, SR., et al.[2018]

Telehealth has proven effective for delivering pediatric occupational therapy, especially through remote parent coaching, which benefits both parents and infants.

In a study assessing the fidelity of a telehealth-delivered autism screening tool, parents adhered to the fidelity checklist 82% of the time, suggesting that this approach is valid for remote assessments in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment Fidelity of Parents Implementing a Standardized Telehealth Infant Autism Screener. Phillips, AQ., Campi, E., Talbott, MR., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10469633/

Parent Coaching in Early Intervention for Autism Spectrum ... This study evaluated providers' use of parent coaching in an early intervention system. Twenty-five early intervention sessions were coded for fidelity.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05176808

Telehealth Parent-Implemented Intervention for Young ... The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD ...

3. clinicaltrial.be clinicaltrial.be/en/details/34964?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Telehealth Parent-Implemented Intervention for Young Chil... In-person Coaching(IPC)​​ Coaches will use an NDBI coaching curriculum to support parents in targeting child social-communication skills during ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4513196/

Naturalistic Developmental Behavioral Interventions This publication, and subsequent studies demonstrating efficacy of early intervention led to two main trends in the provision of autism early intervention.

5. scholarworks.utrgv.edu scholarworks.utrgv.edu/cgi/viewcontent.cgi?article=1324&context=psy_fac

Parents Coaching in Naturalistic Interventions to Improve ... The results indicated a functional relation between the intervention and parent strategy implementation and improvement of children's targeted communication ...

6. withpower.com withpower.com/trial/phase-autism-spectrum-disorder-2022-cc509

Telehealth Parent Coaching for Autism The primary objective of this research study is to improve outcomes involving core social-communication symptoms for young children with ASD or social ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02469870

Study Details | NCT02469870 | ASD Parent Trainer: Online ... The evaluation of the program efficacy will be conducted via a randomized control study with 136 parents of children aged 3-8 who have autism. Investigators ...

8. prweb.com prweb.com/releases/126-family-study-shows-parent-led-therapy-achieves-developmental-progress-in-11-minute-sessions-302598117.html

126-Family Study Shows Parent-Led Therapy Achieves ... A two-year study of 126 families found that children achieved meaningful developmental progress—an average of 23.4 skills mastered—through ...