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Effectiveness of Pivotal Response Treatment: Plasticity of emotion regulation in young children.

Effectiveness of Pivotal Response Treatment: Plasticity of emotion regulation in young children. - Plasticity of emotion regulation in young children.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON39370
Enrollment
90
Registered
2013-04-24
Start date
2013-07-15
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Autism Autism Spectrum Disorders

Interventions

Children with autism and their parents will all (eventually) receive PRT. The duration and amount of treatment sessions is equal for all participants, i.e., children and their parents will go to the

Sponsors

Universiteit Leiden
Lead Sponsor

Eligibility

Age
2 Years to 11 Years

Inclusion criteria

Inclusion criteria: General inclusion criteria include age between 3 and 6 years old, voluntary participation, Dutch or English speaking and a signed informed consent from parents or official caretakers. For the ASD groups additional inclusion criteria are an independent clinical diagnosis of autism according to the DSM-IV criteria that will be confirmed with an ADI-R and ADOS at the start of this study, intelligence quotient above 50, no neurological condition (i.e. epilepsy), severe head trauma with loss of consciousness and / or metabolic diseases.

Exclusion criteria

Exclusion criteria: General exclusion criteria are: - IQ

Design outcomes

Primary

MeasureTime frame
The main study outcome is the change in overall functioning of children with ASD, due to the PRT intervention, as expressed in scores on questionnaires and behavioral observations. We aim to predict these changes in overall functioning from child and parent characteristics on three different measurement levels. Physiological measures, as expressed in heart rate, skin conductance, and salivary cortisol. Cognitive measures, as expressed in intellectual functioning, social cognition, language and executive functioning. And finally, involving behavioral measures as expressed in questionnaires and behavioral observations. For a detailed overview on all the study parameters (categorized by measurement level and by child- or parent characteristics), and their abbreviations, see Table 3 of the research protocol.

Secondary

MeasureTime frame
Child*s background information: The parent will fill in a questionnaire concerning overall psychopathology (CBCL). This questionnaire will be used as a categorical screener for general problem behavior that might cause or mask differences on variables of interest and therefore need to be controlled for. Parent*s background information: Parents will fill in a questionnaire concerning their motivation for their present situation to change (PMI). In addition a psychiatric structured interview will be administered with mother (MINI-plus) to screen for possible overall psychopathology.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)