Autism Spectrum DisorderNCT04992169
Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program
A study testing Smartphone-App Parent Training in Pivotal Response Treatment in people with Autism Spectrum Disorder and Parents, run by University of California, Santa Barbara at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 54 months
- Conditions the study is for
- Autism Spectrum Disorder, Parents
- What is being tested?
- Smartphone-App Parent Training in Pivotal Response Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 54 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Significant medical conditions, seizures, and mental health concerns
- Non-English speaking
- Prior parent training in PRT or similar Naturalistic Developmental Behavioral Intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Santa Barbara
Santa Barbara, California, 93106-9490
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder, Parents
- Being tested
- Smartphone-App Parent Training in Pivotal Response Treatment
- Keywords
- Autism, Treatment, Intervention
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-App Parent Training in Pivotal Response TreatmentBehavioural
Parents are trained in Pivotal Response Treatment, 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 autism. The core smartphone app will offer eight interactive lessons in PRT, consisting of video examples, slides, and brief quizzes.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone App with Video Self-Scoring Functionality | Experimental | In this condition, after parents video-record their delivery of the intervention, they watch their video and are taught to score their own performance/fidelity through question prompts built into the app. When they are finished, the app will offer feedback and follow-up lessons based on the PRT strategies they have not demonstrated consistently. Receives: Behavioral: Smartphone-App Parent Training in Pivotal Response Treatment |
| Smartphone App without Video Self-Scoring Functionality | Experimental | In this condition, after parents video-record their delivery of the intervention, they watch their own video but do not score their performance. Receives: Behavioral: Smartphone-App Parent Training in Pivotal Response Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Parent participants will record and submit a five-minute video of themselves using the PRT intervention strategies with their child using the clinical trial's smartphone app. Trained research assistants will behaviorally score each video using computer-based behavioral coding software (Noldus Observer XT) on a trial-by-trial basis for the presence or absence of each PRT intervention component, which include the use of: child choice, child attention, clear opportunities, contingent reinforcement, reinforcement of child response attempts, a balance of maintenance and acquisition tasks, and task variation. Total uses of these components will be divided by total uses + absences of these components to yield a percentage. The mean percentage of all components will be used as the primary outcome, with a range of 0% to 100% use of the PRT components.
Measured: Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
Secondary outcomes (6)
Change from Baseline in Frequency of Child Vocalizations/Word Use during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.
Parent participants will record and submit a five-minute video of themselves using the PRT intervention strategies with their child using the clinical trial's smartphone app. Trained research assistants will behaviorally score each video using computer-based behavioral coding software (Noldus Observer XT) on a continuous basis for the total frequency of child vocalizations and word use (both prompted and unprompted/spontaneous). The minimum number of vocalizations/words is 0 (no vocalizations or spoken words) and there is technically no maximum (although this is limited by the 5-minute duration of the video probe).
Measured: Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
Change from Baseline in Percentage of Child Positive Affect during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.
Parent participants will record and submit a five-minute video of themselves using the PRT intervention strategies with their child using the clinical trial's smartphone app. Trained research assistants will behaviorally score each video using computer-based behavioral coding software (Noldus Observer XT) on a continuous basis for the total duration of child positive affect (i.e. directed positive facial expressions - observable smiling and laughter). The minimum percentage is 0% (no positive affect) and the maximum is 100% (constant presence of positive affect).
Measured: Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
Change from Baseline in MacArthur-Bates Communicative Development Inventory (CDI), Level I Short Form (Total Score) at 16 weeks
The MacArthur-Bates CDI (Fenson et al., 2000) is a caregiver-reported measure of child expressive vocabulary use. Parents will complete a digital version of the CDI to obtain information on reported word usage and understanding.
Measured: Baseline, 16 weeks (follow-up)
Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Communication Domain) at 16 weeks
The Vineland-III (Sparrow et al., 2016) is a caregiver-completed measure of adaptive functioning in children. Parents will complete a digital version of the Communication Domain of the Vineland-III Parent/Caregiver Rating Form. Item responses are converted to Standard Scores with a mean of 100 and a Standard Deviation of 15.
Measured: Baseline, 16 weeks (follow-up)
Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Socialization Domain) at 16 weeks
The Vineland-III (Sparrow et al., 2016) is a caregiver-completed measure of adaptive functioning in children. Parents will complete a digital version of the Socialization Domain of the Vineland-III Parent/Caregiver Rating Form. Item responses are converted to Standard Scores with a mean of 100 and a Standard Deviation of 15.
Measured: Baseline, 16 weeks (follow-up)
Change from Baseline in Social Responsiveness Scale, Second Edition (SRS-2; Total T-Score) at 16 weeks
The SRS-2 (Constantino \& Gruber, 2007) is a caregiver-completed measure of a child's autism symptom severity. Parents will complete a digital version of the Toddler SRS-2. Item responses are converted to a SRS-2 T-score with a mean of 50 and a Standard Deviation of 10.
Measured: Baseline, 16 weeks (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start23 Aug 2021
- Primary completion30 Mar 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Clinical Trial with two arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Santa Barbara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ty Vernon, University of California, Santa Barbara
- Investigators
- Ty Vernon, Principal investigator, University of California, Santa Barbara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992169
- Sponsor's protocol ID
- 24-21-0034
- Status last verified
- Dec 2023
- First submitted
- 18 Jun 2021
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As part of the informed consent process, participants will consent to allow their deidentified data to be shared with National Database for Autism Research (NDAR).
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinicianless Training in Autism Treatment: An Adaptive Online Parent Education Program
- ClinicalTrials.gov ID
- NCT04992169
- Acronym / sponsor ID
- 24-21-0034
- Conditions
- Autism Spectrum Disorder, Parents
- Keywords
- Autism, Treatment, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of California, Santa BarbaraUniversity, hospital or other
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial with two arms.
| Arm | Type | Receives |
|---|---|---|
| Smartphone App with Video Self-Scoring Functionality | Experimental | Behavioral: Smartphone-App Parent Training in Pivotal Response TreatmentIn this condition, after parents video-record their delivery of the intervention, they watch their video and are taught to score their own performance/fidelity through question prompts built into the app. When they are finished, the app will offer feedback and follow-up lessons based on the PRT strategies they have not demonstrated consistently. |
| Smartphone App without Video Self-Scoring Functionality | Experimental | Behavioral: Smartphone-App Parent Training in Pivotal Response TreatmentIn this condition, after parents video-record their delivery of the intervention, they watch their own video but do not score their performance. |
Who may qualify
- Ages
- 12 to 54 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Significant medical conditions, seizures, and mental health concerns
- Non-English speaking
- Prior parent training in PRT or similar Naturalistic Developmental Behavioral Intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone-App Parent Training in Pivotal Response TreatmentParents are trained in Pivotal Response Treatment, 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 autism. The core smartphone app will offer eight interactive lessons in PRT, consisting of video examples, slides, and brief quizzes. | Behavioural | Smartphone App with Video Self-Scoring Functionality, Smartphone App without Video Self-Scoring Functionality |
Primary outcome
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
Time frame: Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
Parent participants will record and submit a five-minute video of themselves using the PRT intervention strategies with their child using the clinical trial's smartphone app. Trained research assistants will behaviorally score each video using computer-based behavioral coding software (Noldus Observer XT) on a trial-by-trial basis for the presence or absence of each PRT intervention component, which include the use of: child choice, child attention, clear opportunities, contingent reinforcement, reinforcement of child response attempts, a balance of maintenance and acquisition tasks, and task variation. Total uses of these components will be divided by total uses + absences of these components to yield a percentage. The mean percentage of all components will be used as the primary outcome, with a range of 0% to 100% use of the PRT components.
6 secondary outcomes
Change from Baseline in Frequency of Child Vocalizations/Word Use during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.
Time frame: Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
Change from Baseline in Percentage of Child Positive Affect during Behaviorally Coded Parent-Child Intervention Videos at 8 weeks, 16 weeks.
Time frame: Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)
Change from Baseline in MacArthur-Bates Communicative Development Inventory (CDI), Level I Short Form (Total Score) at 16 weeks
Time frame: Baseline, 16 weeks (follow-up)
Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Communication Domain) at 16 weeks
Time frame: Baseline, 16 weeks (follow-up)
Change from Baseline in Vineland Adaptive Behavior Scales, Third Edition (Standard Score on Socialization Domain) at 16 weeks
Time frame: Baseline, 16 weeks (follow-up)
Change from Baseline in Social Responsiveness Scale, Second Edition (SRS-2; Total T-Score) at 16 weeks
Time frame: Baseline, 16 weeks (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Yes. As part of the informed consent process, participants will consent to allow their deidentified data to be shared with National Database for Autism Research (NDAR).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ty Vernon principal investigator
University of California, Santa Barbara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-App Parent Training in Pivotal Response Treatment in people with Autism Spectrum Disorder and Parents, run by University of California, Santa Barbara at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline, 8 weeks (intervention completion), 16 weeks (follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.