Effect of ESDM and PCIT-A in Autism Spectrum Disorder

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.

Conditions

• Autism Spectrum Disorder

Interventions

BEHAVIORAL

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

PCIT is a behavioral family therapy approach emphasizing the integration of traditional child play therapy techniques within a behavioral framework of parent-child therapy and was developed by Eyberg (1988). It is based on attachment theory, social learning theory, and parenting styles theory. Recently, the intervention was adapted to children with ASD by our team (McNeil, Quetsch, \& Anderson, 2019). PCIT-A will last about 8 months, 1 day per week, 60min per day (see Study Protocol, Fig. 2).

BEHAVIORAL

Early Start Denver Model (ESDM) intervention

ESDM intervention provides intensive teaching by trained therapists and parents during natural play and relationship-focused daily routines. It is evidence-based and uses principles of developmental psychology and applied behavior analysis. It was designed for toddlers and preschoolers with autism spectrum disorder by Rogers and Dawson (2010). The first intensive part of ESDM intervention (20h per week) will last 40 weeks of intervention within a period of 12 months. It includes 2 days per week for 6h a day clinic therapy, and 5 days per week for 1h homework tasks, and 2 days per week for 1.5h an early special needs education at home. After the first 12 months, children receive the second lower intensity part of ESDM (7 hours per week). It includes 1 days every two weeks 1h day clinic therapy, and 5 days per week for 1h homework tasks, and 1 days per week for 1.5h an early special needs education at home (see Study Protocol, Fig. 2).

BEHAVIORAL

1-hour ESDM

The active control group for PCIT-A stays in the ESDM day clinic therapy for the 12 hours per week while the PCIT-A group will receive 11 hours of ESDM day clinic therapy and 1 hour PCIT-A per week (see Study Protocol, Fig. 2).

BEHAVIORAL

Early special needs education (ESNE)

The wait-list control group will receive early special needs education. It consists of a 90-minute visit at participants' homes once a week by an employee educated in early special needs education. As soon as space in ESDM is available children will receive the ESDM intervention (stepped-wedge design, see Study Protocol, Fig. 2).

Sponsors & Collaborators

• West Virginia University

  collaborator OTHER

• University of Arkansas

  collaborator OTHER

• Bruno Rhiner

  lead OTHER

Principal Investigators

• Bruno Rhiner, Dr med · Psychiatric Services of Thurgovia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

24 Months

Max Age

59 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-14

Primary Completion

2024-09-18

Completion

2024-10-21

Countries

• Switzerland

Study Locations