Clinical trial NCT04722783: Effect of ESDM and PCIT-A in Autism Spectrum Disorder
Official title: Effect of Early Start Denver Model and Autism-adapted Parent-Child Interaction Therapy on Autism Symptoms and Disruptive Behavior in Toddlers and Preschool Children with Autism Spectrum Disorder (TAFF Pilot Study)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Parent-Child Interaction Therapy
Early Start Denver Model
Autism Spectrum Disorder
Disruptive behavior
Autism Symptoms
Toddlers
Preschool children
Lead sponsor: Psychiatrische Dienste Thurgau
Sponsor class: OTHER
Collaborators: name: West Virginia University
name: University of Arkansas
First posted: 2021-01-25
Enrollment: 24
Sex: ALL
Minimum age (years): 24
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This is a pilot, practical clinical trial with a single-blind, mixed randomized and non-randomized controlled factorial design within a monocentric setup
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Disruptive behavior change (for PCIT-A analysis)
timeFrame: Between 4-month and 12-month FU
measure: Autism symptoms change (for ESDM analysis)
timeFrame: Between baseline to 4 month FU
Secondary outcomes:
measure: Disruptive behavior long-term change (for PCIT-A analysis)
timeFrame: Between 4-month and 24-month FU
measure: Autism symptoms change (for PCIT-A analysis)
timeFrame: Between 4-month and 24-month FU
measure: Developmental level change (for PCIT-A analysis)
timeFrame: Between 4-month and 24-month FU
measure: Non-verbal Intelligence change (for PCIT-A analysis)
timeFrame: Between 4-month and 24-month FU
measure: Adaptive behavior change (for PCIT-A analysis)
timeFrame: Between 4-month and 24-month FU
measure: Social-emotional competence change (for PCIT-A analysis)
timeFrame: Between 4-month and 24-month FU
measure: Parenting stress change (for PCIT-A analysis)
timeFrame: Between 4-month and 24-month FU
measure: Autism symptoms long-term change (for ESDM analysis)
timeFrame: Between baseline and 12-month FU
measure: Disruptive behavior change (for ESDM analysis)
timeFrame: Between baseline and 12-month FU
measure: Developmental level change (for ESDM analysis)
timeFrame: Between baseline and 12-month FU
measure: Non-verbal intelligence change (for ESDM analysis)
timeFrame: Between baseline and 12-month FU
measure: Adaptive behavior change (for ESDM analysis)
timeFrame: Between baseline and 12-month FU
measure: Social-emotional competence change (for ESDM analysis)
timeFrame: Between baseline and 12-month FU
measure: Parenting stress change (for ESDM analysis)
timeFrame: Between baseline and 12-month FU
Other outcomes:
measure: Disruptive behavior change within the PCIT-A subsample
timeFrame: Between 4-month and 24-month FU
measure: Autism symptoms change within the subsample that started with the ESDM intervention
timeFrame: Between baseline and 24-month FU
measure: Age-standardized long-term effect in all outcomes within the ESDM/PCIT-A subsample
timeFrame: Between baseline and 24-month FU
Locations:
city: Münsterlingen
country: Switzerland
facility: Psychiatric Services of Thurgovia
state: Thurgau
Study officials:
affiliation: Psychiatric Services of Thurgovia
name: Bruno Rhiner, Dr med
role: PRINCIPAL_INVESTIGATOR
References: