An exploratory study on the effectiveness of Pivotal Response Treatment and a robot-based Pivotal Response Treatment on social and communicative skills in children with autism spectrum disorder

An exploratory study on the effectiveness of Pivotal Response Treatment and a robot-based Pivotal Response Treatment on social and communicative skills in children with autism spectrum disorder - PicASSo

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41835

Enrollment

Registered

2015-01-08

Start date

2015-06-01

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

autism autism spectrum disorder

Interventions

The study consists of 3 intervention conditions, to which participants are cluster-randomly assigned: 1) Robot-based PRT, on top of care-as-usual (robot therapy condition): includes 20 sessions, o

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: -aged 3-8 years at start of the intervention -clinically diagnosed with ASD, confirmed by the Autism Diagnostic Observation Schedule. -a total intelligence quotient of > 70 -ability to speak single words at least -at least one parent speaks Dutch to the child at home

Exclusion criteria

Exclusion criteria: -medication dosages cannot be fixed during the study -having received PRT earlier

Design outcomes

Primary

Measure	Time frame
1) Clinically significant response (reduction of more than 25%) on the Social Responsiveness Scale (SRS): improvement in social and communicative skills in the child*s natural environment (generalization of skills), rated by a parent and teacher of the child. 2) Clinically significant response on the CGI: improvement in mental health (score much improved or very much improved), rated by a child psychiatrist, blind to the intervention conditions. 3) Significant decrease on the ADOS severity score: decrease in ASD symptoms	—

Measure

Time frame

1) Clinically significant response (reduction of more than 25%) on the Social Responsiveness Scale (SRS): improvement in social and communicative skills in the child*s natural environment (generalization of skills), rated by a parent and teacher of the child. 2) Clinically significant response on the CGI: improvement in mental health (score much improved or very much improved), rated by a child psychiatrist, blind to the intervention conditions. 3) Significant decrease on the ADOS severity score: decrease in ASD symptoms

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Secondary

Measure	Time frame
1) Improvement in communicative skills during PRT interventions: specific communicative skills that are targeted by the PRT with the level of help (prompts) that is needed by the child to perform these skills are assessed in the Robot-based PRT condition and PRT condition. A 15-minute PRT screening scenario is developed and simulated at 4 measurement points. 2) Spontaneous appropriate behaviour in learning moments during PRT: in the robot-based PRT sessions and PRT sessions, a percentage is calculated for the amount of learning moments the child shows spontaneous appropriate behaviour in. 3) Child-rearing pressure experienced by parents: this is assessed with a digital questionnaire called the "OBVL", at 4 moments in the study 4) Likability of the robot by the child: after each session that involves the robot within the robot-based PRT condition, the child is asked how much he or she likes the robot using a 5-point VAS line. 5) Child's affect during robot-based PRT sessions: before and after each session involving the robot within the robot-based PRT condition, the child is asked how he or she feels at that moment using a 5-point VAS line. 6) Salivary cortisol, oxytocin and testosterone: Before and after PRT session 1, 10 and 20, the child is asked to gently spit in a plastic tube.	—

Measure

Time frame

1) Improvement in communicative skills during PRT interventions: specific communicative skills that are targeted by the PRT with the level of help (prompts) that is needed by the child to perform these skills are assessed in the Robot-based PRT condition and PRT condition. A 15-minute PRT screening scenario is developed and simulated at 4 measurement points. 2) Spontaneous appropriate behaviour in learning moments during PRT: in the robot-based PRT sessions and PRT sessions, a percentage is calculated for the amount of learning moments the child shows spontaneous appropriate behaviour in. 3) Child-rearing pressure experienced by parents: this is assessed with a digital questionnaire called the "OBVL", at 4 moments in the study 4) Likability of the robot by the child: after each session that involves the robot within the robot-based PRT condition, the child is asked how much he or she likes the robot using a 5-point VAS line. 5) Child's affect during robot-based PRT sessions: before and after each session involving the robot within the robot-based PRT condition, the child is asked how he or she feels at that moment using a 5-point VAS line. 6) Salivary cortisol, oxytocin and testosterone: Before and after PRT session 1, 10 and 20, the child is asked to gently spit in a plastic tube.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)