Clinical trial NCT04992169: Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program
Official title: Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Parents
Keywords: Autism
Treatment
Intervention
Lead sponsor: University of California, Santa Barbara
Sponsor class: OTHER
First posted: 2021-08-05
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial with two arms.
Primary purpose: TREATMENT

Brief summary: This project will examine the feasibility, acceptability, and preliminary efficacy of using a smartphone app-based parent training program focused on early autism intervention strategies.

Detailed description: Despite scientific advances in treatment for autism spectrum disorder (ASD), most families across the United States do not have access to high quality autism services, let alone the best autism treatment models available. There are a number of reasons for this concerning reality, including the limited number of trained autism clinicians around the country, the rising cost of services, geographic distance from autism service providers, and difficulties in being able to effectively and efficiently train a large number of people in the latest treatment models.

This proposed project focuses on the Department of Defense Autism Research Program - Clinical Translational Research Award Area of Interests focused on Dissemination/Implementation of Clinically Validated Interventions and Behavioral Therapies for ASD Core Symptoms. These areas focus on effective strategies for taking what works (in this case, highly effective autism treatments shown to improve social communication and motivation in children with autism) and spreading or distributing these treatments so that they can benefit a much larger portion of the population. This is important, because a highly effective treatment is of little use if only people in a few areas can benefit from its effect, while the rest of the nation continues to use outdated, less effective strategies.

To accomplish the goal of distributing a highly effective intervention to the general public, this proposed study will take advantage of the wide-spread use of smartphones nationwide. This study proposes to develop and evaluate smartphone apps as a way to train parents of young children with ASD in an autism treatment model known as Pivotal Response Treatment (PRT). Families will be recruited nationwide to participate in this trial.

Pivotal Response Treatment is a well-known, scientifically supported treatment that focuses on using child motivation, play-based lessons, and parent involvement to target the language skills and social engagement of children with ASD. The core smartphone app will offer eight interactive lessons in PRT, consisting of video examples, slides, and brief quizzes. After each lesson, parents will be asked to record a brief video of themselves using PRT with their child, which is submitted within the app to the research team so that they can monitor their mastery of the strategies over time. The investigators will also ask parents to complete autism-related and developmental surveys before and after participation so that the research team can monitor how their child is improving.

Ultimately, the objective of this trial is to develop and test smartphone apps to deliver a highly effective autism intervention to families nationwide. The use of this technology will ensure that families can access gold standard autism treatment regardless of their geographic location, work schedules, or financial background. If successful, the investigators plan to conduct an even larger nationwide study and ultimately make the app available in smartphone app stores so that families everywhere can train themselves in this treatment approach.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of autism spectrum disorder
* Parent endorsements of significant language delay
* Between the ages of 1.0 and 4.5 years (12 and 54 months)
* Parents willing to complete intake and follow-up assessments, complete the eight weekly PRT lessons, record and submit parent-child PRT videos, and review these videos on a weekly basis.
* Access to an internet connection and an iOS smartphone or tablet that can supports the app and records video.

Exclusion Criteria:

* Significant medical conditions, seizures, and mental health concerns
* Non-English speaking
* Prior parent training in PRT or similar Naturalistic Developmental Behavioral Intervention

Primary outcomes:
measure: Change from Baseline in Parent Fidelity of Implementation of Pivotal Response Treatment (PRT) during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks
timeFrame: Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
Secondary outcomes:
measure: Change from Baseline in Frequency of Child Vocalizations/Word Use during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.
timeFrame: Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
measure: Change from Baseline in Percentage of Child Positive Affect during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.
timeFrame: Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
measure: Change from Baseline in MacArthur-Bates Communicative Development Inventory (CDI), Level I Short Form (Total Score) at 16 weeks
timeFrame: Baseline, 16 weeks (follow-up)
measure: Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Communication Domain) at 16 weeks
timeFrame: Baseline, 16 weeks (follow-up)
measure: Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Socialization Domain) at 16 weeks
timeFrame: Baseline, 16 weeks (follow-up)
measure: Change from Baseline in Social Responsiveness Scale, Second Edition (SRS-2; Total T-Score) at 16 weeks
timeFrame: Baseline, 16 weeks (follow-up)
Other outcomes:
measure: Change from Baseline in Percentage of Child Eye Contact during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.
timeFrame: Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
measure: Scale of Treatment Perceptions (Total Score)
timeFrame: 8 weeks
measure: Parent Adherence to Treatment and Competence Measure
timeFrame: 8 weeks
Locations:
city: Santa Barbara
country: United States
facility: University of California, Santa Barbara
state: California
Study officials:
affiliation: University of California, Santa Barbara
name: Ty Vernon
role: PRINCIPAL_INVESTIGATOR
References: