Behavioral Therapy for Autism
(M-PRT-IS Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Disqualifiers: Non-english speaking, Reside outside US, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.
Will I have to stop taking my current medications?
The trial requires that participants have stable medication for at least two weeks with no expected changes, so you can continue taking your current medications as long as they are stable.
What data supports the effectiveness of the treatment Modified Pivotal Response Treatment, Pivotal Response Treatment, PRT, Natural Language Paradigm (NLP) for autism?
Research shows that Pivotal Response Treatment (PRT) helps improve communication and social skills in children with autism. Studies also indicate that the Natural Language Paradigm (NLP) can increase speech in autistic children when used by trained parents at home.
12345Is Pivotal Response Treatment (PRT) safe for humans?
The research on Pivotal Response Treatment (PRT) for autism spectrum disorder does not report any safety concerns, suggesting it is generally safe for use in humans.
34567How is Modified Pivotal Response Treatment (PRT) different from other autism treatments?
Modified Pivotal Response Treatment (PRT) is unique because it uses a naturalistic approach, focusing on motivation and child-led interactions in everyday settings, unlike more structured methods like traditional applied behavior analysis (ABA). This approach has been shown to improve communication and social skills more effectively by incorporating natural reinforcers and allowing children to initiate interactions.
458910Eligibility Criteria
This trial is for young people with autism who have a hard time dealing with changes in their routine. They should score high on a specific test for this behavior, be stable on current treatments for two weeks, live in the U.S., and both they and their parents must speak English.Inclusion Criteria
I am over 18 and my child is between 4 and 17 years old.
English-speaking parent and youth able to consistently participate in study procedures
I have been diagnosed with ASD or suspected to have ASD, confirmed by ADI-R.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a 12-week behavioral intervention program delivered via telemedicine, consisting of parent-training and parent-mediated intervention
12 weeks
12 visits (virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 weeks
Participant Groups
The study tests a 12-week program to help autistic youth cope better with change. It involves parent training and child-focused activities delivered online for one hour each week.
1Treatment groups
Experimental Treatment
Group I: Remote (Telehealth) Intervention ProgramExperimental Treatment1 Intervention
Modified Pivotal Response Treatment is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Pivotal Response Treatment for:
- Autism Spectrum Disorder (ASD)
- Insistence on Sameness
🇪🇺 Approved in European Union as Pivotal Response Treatment for:
- Autism Spectrum Disorder (ASD)
🇨🇦 Approved in Canada as Pivotal Response Treatment for:
- Autism Spectrum Disorder (ASD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
401 Quarry Road (Remote Study)Stanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
References
Using Pivotal Response Treatment to Improve Language Functions of Autistic Children in Special Schools: A Randomized Controlled Trial. [2023]Language difficulties exert profound negative effects on the cognitive and social development of autistic children. Pivotal Response Treatment (PRT) is a promising intervention for improving social communication in autistic children, but there is a lack of a comprehensive examination of language functions. This study aimed to investigate the effectiveness of PRT in promoting the primary language functions (requesting, labeling, repeating, responding) defined by (Skinner, B. F. (1957). Verbal behavior. Martino Publishing.) theory of verbal behavior in autistic children. Thirty autistic children were randomly divided into the PRT group (Mage = 6.20, SDage = 1.21) and control group (Mage = 6.07, SDage = 1.49). The PRT group were provided with an 8-week training of the PRT motivation component in addition to treatment as usual (TAU) in their schools, whereas the control group only received TAU. Parents of the PRT group were also trained to practice the PRT motivation procedures at home. The PRT group demonstrated greater improvements in all four measured language functions compared to the control group. The improvement in language functions in the PRT group was generalized and maintained at the follow-up assessment. In addition, the PRT intervention enhanced untargeted social and communicative functioning, cognition, motor skills, imitation, and adaptive behaviors in the autistic children. In conclusion, language intervention using the motivation component of PRT is effective in promoting language functions as well as widespread untargeted cognitive and social functions in autistic children.
Feasibility and Acceptability of Delivering Pivotal Response Treatment for Autism Spectrum Disorder via Telehealth: Pilot Pre-Post Study. [2023]Pivotal response treatment (PRT), an evidence-based and parent-delivered intervention, is designed to improve social communication in autistic individuals.
Toward optimal outcome following pivotal response treatment: a case series. [2020]There is a growing literature on children with autism spectrum disorder (ASD) who respond favorably to behavioral treatment, which is often termed "optimal outcome." Rates and definitions of optimal outcome vary widely. The current case series describes an empirically validated behavioral treatment approach called Pivotal Response Treatment (PRT). We present two preschool-aged children who received an intensive course of PRT and seem to be on a trajectory toward potential optimal outcome. Understanding response to treatment and predictors of response is crucial, not necessarily to predict who may succeed, but to individualize medicine and match children with customized treatment programs that will be best tailored to their unique and varied needs.
Pivotal response treatment for children with autism spectrum disorder: a systematic review of research quality. [2018]Research has indicated support for pivotal response treatment (PRT) as an effective, efficacious and naturalistic intervention for communication and social functioning of children with autism spectrum disorder (ASD). Previously not undertaken, this article describes a systematic evaluation of the adherence of PRT research studies to standards of ASD research quality.
Training parents to use the natural language paradigm to increase their autistic children's speech. [2019]Parents of four nonverbal and four echolalic autistic children were trained to increase their children's speech by using the Natural Language Paradigm (NLP), a loosely structured procedure conducted in a play environment with a variety of toys. Parents were initially trained to use the NLP in a clinic setting, with subsequent parent-child speech sessions occurring at home. The results indicated that following training, parents increased the frequency with which they required their children to speak (i.e., modeled words and phrases, prompted answers to questions). Correspondingly, all children increased the frequency of their verbalizations in three nontraining settings. Thus, the NLP appears to be an efficacious program for parents to learn and use in the home to increase their children's speech.
Improvements in social and adaptive functioning following short-duration PRT program: a clinical replication. [2021]Pivotal Response Treatment (PRT) is an empirically validated behavioral treatment for individuals with autism spectrum disorders (ASD). The purpose of the current study was to assess the efficacy of PRT for ten cognitively-able preschool-aged children with ASD in the context of a short-duration (4-month) treatment model. Most research on PRT used individual behavioral goals as outcome measures, but the current study utilized standardized assessments of broader-based social communication and adaptive skills. The children made substantial gains; however, magnitude and consistency of response across measures were variable. The results provide additional support for the efficacy of PRT as well as evidence for improvements in higher-order social communication and adaptive skill development within the context of a short-duration PRT model.
Pivotal Response Treatment for School-Aged Children and Adolescents with Autism Spectrum Disorder: A Randomized Controlled Trial. [2021]Pivotal Response Treatment (PRT) is promising for children with Autism Spectrum Disorder (ASD), but more methodologically robust designed studies are needed. In this randomized controlled trial, forty-four children with ASD, aged 9-15 years, were randomly allocated to PRT (n = 22) or treatment-as-usual (TAU; n = 22). Measurements were obtained after 12- and 20-weeks treatment, and 2-month follow-up. PRT resulted in significant greater improvements on parent-rated social-communicative skills after 12 weeks treatment (p = .004, partial η2 = 0.22), compared to TAU. Furthermore, larger gains in PRT compared to TAU were observed on blindly rated global functioning, and parent-rated adaptive socialization skills and attention problems. Implications for clinical practice and suggestions for future research are discussed.
A randomized clinical trial comparison between pivotal response treatment (PRT) and structured applied behavior analysis (ABA) intervention for children with autism. [2021]Accumulating studies are documenting specific motivational variables that, when combined into a naturalistic teaching paradigm, can positively influence the effectiveness of interventions for children with autism spectrum disorder (ASD). The purpose of this study was to compare two applied behavior analysis (ABA) intervention procedures, a naturalistic approach, pivotal response treatment (PRT) with a structured ABA approach in a school setting. A randomized clinical trial design using two groups of children, matched according to age, sex and mean length of utterance was used to compare the interventions. The data showed that the PRT approach was significantly more effective in improving targeted and untargeted areas after 3 months of intervention. The results are discussed in terms of variables that produce more rapid improvements in communication for children with ASD.
Comparisons of discrete-trial and normalized behavioral language intervention for young children with autism. [2019]This critical review examined a series of 10 controlled studies in which traditional operant behavioral procedures were compared with more recently developed normalized interventions for teaching language to young children with autism. Main characteristics of the older treatments include highly structured direct teaching sessions of discrete trials, teacher initiation, artificial reinforcers, and response shaping. Normalized interventions consist of loosely structured sessions of indirect teaching with everyday situations, child initiation, natural reinforcers, and liberal criteria for presentation of reinforcers. The main conclusion was that in all eight studies with language criterion responses, normalized language training was more effective than discrete-trial training. Furthermore, in both studies that assessed parental affect, normalized treatment yielded more positive affect than discrete-trial training.
Naturalistic teaching approach to develop spontaneous vocalizations and augmented communication in children with autism spectrum disorder. [2021]Naturalistic developmental behavioral interventions (NDBI) have been shown to facilitate the development of spontaneous language in individuals with speech and language impairment. Several meta-analyses have reported a small number of studies that utilized naturalistic teaching approaches combined with augmentative and alternative communication (AAC) interventions to develop requesting skills in individuals with autism spectrum disorder (ASD). Therefore, the main purpose of this study was to determine whether a natural language paradigm (NLP) and time delay is effective in expanding vocal and augmented requesting skills in three children with ASD between the ages of 4 and 6 years. A concurrent multiple baseline design across participants was used to evaluate the effectiveness of the intervention. The results of the study demonstrated that the participants were successful in emitting vocal requests when both modalities were available and NLP combined with time delay was effective in increasing spontaneous vocal requests in all participants.