Effect of ESDM and PCIT-A in Autism Spectrum Disorder

NCT04722783 | Terminated

• 2 other identifiers: Protocol_PDT_010_TAFF2020-02787 (EKOS 20/223)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Parent-Child Interaction Therapy; Early Start Denver Model; Autism Spectrum Disorder; Disruptive behavior; Autism Symptoms; Toddlers; Preschool children

Outcome Measures

Primary Outcomes (2)

• Disruptive behavior change (for PCIT-A analysis)

  Change from 4-month to 12-month Follow-Up (FU) in a composite score of Dyadic Parent-Child Interaction Coding System percentage compliance score and Eyberg Child Behavior Inventory intensity score (objective and parent-reported disruptive behavior; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a worse outcome)

  Between 4-month and 12-month FU

• Autism symptoms change (for ESDM analysis)

  Change from baseline to 4-month FU in Quantitative Checklist for Autism in Toddlers score (parent-reported, range: 0-100 points; higher scores mean a worse outcome)

  Between baseline to 4 month FU

Secondary Outcomes (14)

• Disruptive behavior long-term change (for PCIT-A analysis)

  Between 4-month and 24-month FU

• Autism symptoms change (for PCIT-A analysis)

  Between 4-month and 24-month FU

• Developmental level change (for PCIT-A analysis)

  Between 4-month and 24-month FU

• Non-verbal Intelligence change (for PCIT-A analysis)

  Between 4-month and 24-month FU

• Adaptive behavior change (for PCIT-A analysis)

  Between 4-month and 24-month FU

Other Outcomes (3)

• Disruptive behavior change within the PCIT-A subsample

  Between 4-month and 24-month FU

• Autism symptoms change within the subsample that started with the ESDM intervention

  Between baseline and 24-month FU

• Age-standardized long-term effect in all outcomes within the ESDM/PCIT-A subsample

  Between baseline and 24-month FU

Study Arms (4)

ESDM and PCIT-A

EXPERIMENTAL

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

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

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

Behavioral: Early Start Denver Model (ESDM) intervention; Behavioral: 1-hour ESDM

PCIT-A and active control for ESDM

EXPERIMENTAL

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

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

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

Behavioral: Early special needs education (ESNE)

Interventions

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

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).

Also known as: Intervention I

ESDM and PCIT-A; PCIT-A and active control for ESDM

Early Start Denver Model (ESDM) intervention BEHAVIORAL

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).

Also known as: Intervention II

ESDM and PCIT-A; ESDM and active control for PCIT-A

1-hour ESDM BEHAVIORAL

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).

Also known as: Active control for Intervention I

ESDM and active control for PCIT-A

Early special needs education (ESNE) BEHAVIORAL

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).

Also known as: Active control for Intervention II

Active control for ESDM and PCIT-A; PCIT-A and active control for ESDM

Eligibility Criteria

• Age: 24 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bruno Rhiner: lead
• West Virginia University: collaborator
• University of Arkansas: collaborator

Study Sites (1)

Psychiatric Services of Thurgovia

Münsterlingen, Thurgau, 8596, Switzerland

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Problem Behavior

Interventions

Methods

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Bruno Rhiner, Dr med

  Psychiatric Services of Thurgovia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The DPICS rating - as part of the primary outcome - is the only measure that is masked
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Child and Adolescent Psychiatry

Model Details: This is a pilot, practical clinical trial with a single-blind, mixed randomized and non-randomized controlled factorial design within a monocentric setup

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 25, 2021
• Study Start: January 14, 2021
• Primary Completion: September 18, 2024
• Study Completion: October 21, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-06

Locations

CH (1)