Telehealth vs In-Person Behavior Therapy for Autism
Recruiting in Palo Alto (17 mi)
+1 other location
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2 & 3
Recruiting
Sponsor: Stanford University
Disqualifiers: Severe behavior, Sensory impairment, Genetic condition, others
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of the research is to determine whether parent-mediated behavior therapy for challenging behavior commonly displayed by children with autism spectrum disorder (ASD) can be as effective when delivered via telehealth as when delivered in-person.
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 data supports the effectiveness of the treatment Parent-Mediated Behavior Therapy for Autism?
Research shows that both self-directed and therapist-assisted telehealth parent-mediated interventions can improve language and social skills in children with autism. Therapist-assisted programs may offer additional benefits, such as better parent intervention fidelity and improved social skills in children.
12345Is parent-mediated behavior therapy safe for humans?
Parent-mediated behavior therapy, including telehealth versions, is generally considered safe for humans. Studies have shown that parents and children benefit from these interventions, with improvements in skills and satisfaction, and no significant safety concerns have been reported.
24678How is Parent-Mediated Behavior Therapy for autism different from other treatments?
Parent-Mediated Behavior Therapy is unique because it involves training parents to deliver therapy to their children, which can be done through telehealth, making it more accessible. This approach empowers parents to be active participants in their child's treatment, potentially improving intervention fidelity and parent-child interactions, especially when therapist assistance is provided.
12349Eligibility Criteria
This trial is for children aged 3 to 5 with Autism Spectrum Disorder (ASD) who show challenging behavior daily. It's also for their English-speaking parents or caregivers, who can manage these behaviors safely and commit to a 12-week treatment program.Inclusion Criteria
The child has been diagnosed with ASD (autism) and has a diagnostic report confirming the diagnosis.
My child's main caregiver can help with the treatment for 12 weeks.
I can safely manage my child's difficult behavior during the study.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Parent-mediated behavior therapy delivered via telehealth or in-person
4 weeks
Weekly sessions (telehealth or in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing if parent-mediated behavior therapy for kids with ASD can work just as well over telehealth as it does in person. Parents will be trained to help manage their child's challenging behaviors.
3Treatment groups
Active Control
Placebo Group
Group I: In-person treatmentActive Control1 Intervention
Group II: Telehealth-enabled treatmentActive Control1 Intervention
Group III: PsychoeducationPlacebo Group1 Intervention
Parent-Mediated Behavior Therapy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Parent-Mediated Behavioral Treatment for:
- Autism Spectrum Disorder (ASD) - Challenging Behaviors
🇪🇺 Approved in European Union as Parent-Mediated Behavioural Therapy for:
- Autism Spectrum Disorder (ASD) - Challenging Behaviors
- Improvement of Adaptive Functioning
🇨🇦 Approved in Canada as Parent-Mediated Intervention for:
- Autism Spectrum Disorder (ASD) - Challenging Behaviors
- Enhancement of Parent-Child Interaction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Behavior Change InstituteAlamogordo, NM
Stanford UniversityStanford, CA
Loading ...
Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
United States Department of DefenseCollaborator
Behavior Change InstituteCollaborator
References
The impact of a telehealth platform on ABA-based parent training targeting social communication in children with autism spectrum disorder. [2022]Interventions based upon applied behaviour analysis (ABA) have been shown to be best practice for children with autism spectrum disorder. However, in many parts of the world there is a shortage of appropriately trained behaviour analysts. Telehealth is a potential solution to increasing access to ABA. Our study assessed the use of telehealth to provide parent training in naturalistic teaching strategies designed to increase child communication skills. Five parent child dyads took part in the training, utilising didactic training and synchronous coaching. Parents could be trained to a high level of fidelity and viewed the training favourably. Children showed variable gains in communication and improved positive affect. The project was cost effective in comparison with traditional training models.
Comparison of a Self-Directed and Therapist-Assisted Telehealth Parent-Mediated Intervention for Children with ASD: A Pilot RCT. [2022]This pilot RCT compared the effect of a self-directed and therapist-assisted telehealth-based parent-mediated intervention for young children with ASD. Families were randomly assigned to a self-directed or therapist-assisted program. Parents in both groups improved their intervention fidelity, self-efficacy, stress, and positive perceptions of their child; however, the therapist-assisted group had greater gains in parent fidelity and positive perceptions of child. Children in both groups improved on language measures, with a trend towards greater gains during a parent-child interaction for the therapist-assisted group. Only the children in the therapist-assisted group improved in social skills. Both models show promise for delivering parent-mediated intervention; however, therapist assistance provided an added benefit for some outcomes. A full-scale comparative efficacy trial is warranted.
Relative Efficacy of Self-directed and Therapist-assisted Telehealth Models of a Parent-mediated Intervention for Autism: Examining Effects on Parent Intervention Fidelity, Well-being, and Program Engagement. [2023]Although there is growing interest in telehealth to deliver parent-mediated intervention for autistic children, empirical evaluations are limited, and little is known regarding the relative benefits of self-directed and therapist-assisted telehealth interventions. This study examined the effect of self-directed and therapist-assisted ImPACT Online on parent learning and well-being, moderators of treatment, and predictors of program engagement.
Parent Engagement With a Telehealth-Based Parent-Mediated Intervention Program for Children With Autism Spectrum Disorders: Predictors of Program Use and Parent Outcomes. [2022]There has been growing interest in using telehealth to increase access to parent-mediated interventions for children with ASD. However, little is known about how parents engage with such programs.
Clinical outcomes of children with ASD - Preliminary findings from a 18 month follow up study. [2021]Parent-mediated intervention for children with Autism Spectrum Disorder (ASD) is a critical component to deliver evidence-based interventions in resource-limited settings. There is a need for methodologically rigorous longitudinal and follow-up studies of children with ASD to understand clinical outcome and developmental trajectories.
Video-Feedback Approach Improves Parental Compliance to Early Behavioral Interventions in Children with Autism Spectrum Disorders during the COVID-19 Pandemic: A Pilot Investigation. [2022]In the field of autism intervention, a large amount of evidence has demonstrated that parent-mediated interventions are effective in promoting a child's learning and parent caring skills. Furthermore, remote delivery treatments are feasible and can represent a promising opportunity to reach families at distance with positive results. Recently, the sudden outbreak of COVID-19 dramatically disrupted intervention services for autism and forced an immediate reorganization of the territory services toward tele-assisted intervention programs, according to professional and local resources. Our study aimed to conduct a retrospective pilot exploratory investigation on parental compliance, participation, and satisfaction in relation to three different telehealth intervention modalities, such as video feedback, live streaming, and psychoeducation, implemented in the context of a public community setting delivering early autism intervention during the COVID-19 emergency. We found that parents who attended video feedback expressed the highest rate of compliance and participation, while parental psychoeducation showed significantly lower compliance and the highest drop-out rate. Regardless of the tele-assistance modality, all the participants expressed satisfaction with the telehealth experience, finding it useful and effective. Potential benefits and advantages of different remote modalities with reference to parent involvement and effectiveness are important aspects to be taken into account and should be further investigated in future studies.
Managing Autism Spectrum Disorder in the Face of Pandemic Using Internet-Based Parent-Mediated Interventions: A Systematic Review of Randomized Controlled Trials. [2022]ASD is a neurodevelopmental disorder that is primarily treated with psychosocial intervention. However, it is costly and requires extensive resources to be effective. This inaccessibility is also further worsened by the ongoing COVID-19 pandemic, making the shift to a digital approach a sensible option. Among the available ASD therapies, parent-mediated interventions (PMIs) have a broad application and lower implementation cost. Hence, this systematic review aims to evaluate the potential that telehealth-based PMI holds and explore its feasibility throughout the COVID-19 pandemic. To build up this study, a systematic search through PubMed, Scopus, ProQuest, Wiley, and Cochrane was performed until 14 January 2021. Using the preferred Reporting Items for Systematic Review and Meta-Analysis guidelines, we ultimately included six studies in the review. Each study was evaluated utilizing the Cochrane Risk of Bias (ROB)-2 tool. Generally, parents' outcomes (knowledge, satisfaction, and compliance) were higher in intervention group (E-learning) compared to control (standard treatment or wait-list). Children also showed some improvements in social skill, communication skill, and intelligence after receiving the treatment. In addition, coaching or therapist sessions were found to be crucial as adjuvant to support parents during the intervention. In conclusion, internet-based parent-mediated interventions are promising and recommended for managing ASD patients, in the face of pandemic. However, more variety in study locations is also needed, particularly in low- and middle-income countries, to tackle the knowledge and clinical application gap. Further research should be conducted with a uniform measurement tool to achieve the same perception and reliable pooled analysis.
Systematic review of factors that may influence the outcomes and generalizability of parent-mediated interventions for young children with autism spectrum disorder. [2020]Parent mediated interventions have the potential to positively influence the interactions and developmental outcomes of children with autism spectrum disorder (ASD). However, a range of factors relating to children, parents and caregivers, and study design may impact on outcomes and thus the generalizability of these interventions to the broader community. The objective of this review was to examine factors that may influence the feasibility, appropriateness, effectiveness, and generalizability of parent mediated interventions for children with ASD. We conducted a systematic review, yielding 41 articles. There was substantial variability in the intervention type, intensity, and study quality. Notably, 46 different inclusion/exclusion criteria were reported across studies including factors relating to children's development, access to other services, comorbidities, parental factors, and access to the intervention. Fifteen articles included examination of 45 different factors potentially associated with, or influencing, intervention outcomes including child (e.g., language skills, ASD severity, cognition) and parent (e.g., adherence and fidelity, education) factors. Although there is clear evidence for an increasingly sophisticated (e.g., systematic phased research for some interventions) and diverse (e.g., studies in geographical diverse contexts including low-resource communities) approach to research examining parent mediated interventions, there remains a need for improved study quality and measurement consistency in research, including a detailed examination of factors that may predict, moderate, and mediate intervention effectiveness for children and their parents. Autism Res 2019, 12: 1304-1321. © 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Parent mediated interventions-in which parents adapt their own behavior or deliver interventions to help their children learn-appear to be effective for some children with autism spectrum disorder. In this review, we identified a range of child, parent, and study design factors that may influence intervention outcomes and ultimately the uptake of these approaches in the community. We suggest that research in this area could be further improved by ensuring that studies include diverse groups of children and parents, and by using study designs that help to establish not only if interventions work, but for whom they work best and why.
Behavioral Parent Training via Telehealth for Autistic Children: Further Exploration of Feasibility During the COVID-19 Pandemic. [2023]Many autistic children exhibit challenging and disruptive behaviors that can present challenges for both children and their families by interfering with acquisition of adaptive skills and affecting family and peer relationships. Behavioral parent training (BPT) is an evidence-based approach to reducing autistic children's disruptive behavior, but many families face a number of barriers to accessing BPT, such as availability of BPT in their community, and transportation and scheduling challenges. Therefore, we sought to explore the feasibility and promise of effectiveness of adapting an established BPT program to a telehealth format during the COVID-19 pandemic.