Effect of ESDM and PCIT-A in Autism Spectrum Disorder (TAFF)

Bruno Rhiner

Status: Terminated

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Early special needs education (ESNE); Behavioral: 1-hour ESDM; Behavioral: Early Start Denver Model (ESDM) intervention; Behavioral: Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A)

Study type: Interventional

Funder types: Other

Identifiers

NCT04722783

Protocol_PDT_010_TAFF

2020-02787 (EKOS 20/223) (Other Identifier)

Details and patient eligibility

About

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.

Full 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 für Autismus und Frühförderung [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.

Enrollment: 24 patients

Sex: All

Ages: 24 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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24 participants in 4 patient groups

ESDM and PCIT-A

Experimental group

Description:

Participants in this arm receive 2 years ESDM and after 4 months PCIT-A for 8 months (see Study Protocol, Figure 2).

Treatment:

Behavioral: Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A)

Behavioral: Early Start Denver Model (ESDM) intervention

ESDM and active control for PCIT-A

Experimental group

Description:

Participants in this arm receive 2 years ESDM and after 4 months 1h-ESDM as active control instead of 1h-PCIT-A for 8 months

Treatment:

Behavioral: Early Start Denver Model (ESDM) intervention

Behavioral: 1-hour ESDM

PCIT-A and active control for ESDM

Experimental group

Description:

Participants receive after 4 month PCIT-A for 8 months and early special needs education as an active control for ESDM.

Treatment:

Behavioral: Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A)

Behavioral: Early special needs education (ESNE)

Active control for ESDM and PCIT-A

Active Comparator group

Description:

Participants receive early special needs education as an active control for ESDM and PCIT-A.

Treatment:

Behavioral: Early special needs education (ESNE)