Effect of ESDM and PCIT-A in Autism Spectrum Disorder

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    28
  • sponsor
    Bruno Rhiner
Updated on 15 February 2021

Summary

Children with ASD often show disruptive behaviors. However, interventions that were specifically designed to improve these symptoms have not been sufficiently investigated, especially in children with level 1 to level 3 ASD. PCIT has large effects on externalizing behavior problems in children with disruptive behavior disorders. Recently PCIT was adapted for children with autism spectrum disorder (PCIT-A). ESDM is an evidence-based treatment for ASD but has not been investigated in combination with PCIT-A.

As primary aims, the investigators assess a) the effect of PCIT-A on disruptive behavior and b) the effect of ESDM on autism symptoms in toddlers and preschool children with ASD level 1 to 3. As secondary aims, the investigators evaluate a) the maintenance of the effect of PCIT-A one year after the end of intervention and b) the effect of both interventions on secondary outcomes (developmental level, intelligence, adaptive behavior, and parenting stress), c) the combined intervention effect of PCIT-A and ESDM depending on intervention overlap periods.

Description

Autism spectrum disorder (ASD) is a life-long neurodevelopmental disorder with recognizable symptoms often beginning between one and two years of age and an estimated prevalence of about 0.6%. Both social communication deficits, and restrictive and repetitive behavior depict the core symptoms of ASD.

ESDM is an evidence-based treatment for ASD. A recent meta-analysis comprising 12 studies show favorable effects of ESDM on cognition and language with a moderate effect size, in contrast to control groups. ESDM showed to become cost-efficient within a few years after treatment as a result of less use of other health care services in the years following the intervention.

Children with ASD often show disruptive behaviors such as angry outbursts, irritability, aggressive and oppositional behaviors. However, interventions that were specifically designed to improve these symptoms have not been sufficiently investigated, especially in children with level 1 to level 3 ASD. PCIT has large effects on externalizing behavior problems in children with disruptive behavior disorders. Recently, PCIT was adapted for children with autism spectrum disorder (PCIT-A).

As primary aims of the so-called TAFF (Tagesklinik fr Autismus und Frhfrderung [Day Clinic for Autism and Early Intervention]) pilot study, the investigators assess a) the effect of PCIT-A on disruptive behavior and b) the effect of ESDM on autism symptoms in toddlers and preschool children with ASD level 1 to 3. As secondary aims, the investigators evaluate a) the maintenance of the effect of PCIT-A one year after the end of intervention and b) the effect of both interventions on secondary outcomes (developmental level, intelligence, adaptive behavior, and parenting stress), c) the combined intervention effect of PCIT-A and ESDM depending on intervention overlap periods.

Details
Condition Pervasive developmental disorder, Autism Spectrum Disorder (ASD), Autism Spectrum Disorder, Autism Spectrum Disorder (ASD), autism spectrum disorders
Treatment Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A), Early Start Denver Model (ESDM) intervention, 1-hour ESDM, Early special needs education (ESNE)
Clinical Study IdentifierNCT04722783
SponsorBruno Rhiner
Last Modified on15 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

ASD level 1 to 3
Time commitment of at least one parent (including homework and traveling time)
Willingness of one parent to be the study informant over the whole study period

Exclusion Criteria

Insufficient German language skills of both parents to participate in the intervention
Severe hearing or visual impairment
Attention deficit hyperactivity disorder
Epilepsy
Rett syndrome
Other rare, severe neurological disorders that interfere with therapy
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