Effect of ESDM and PCIT-A in Autism Spectrum Disorder
- Conditions
- Autism Spectrum Disorder
- Interventions
- Behavioral: Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A)Behavioral: Early special needs education (ESNE)Behavioral: Early Start Denver Model (ESDM) interventionBehavioral: 1-hour ESDM
- Registration Number
- NCT04722783
- Lead Sponsor
- Bruno Rhiner
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description PCIT-A and active control for ESDM Early special needs education (ESNE) Participants receive after 4 month PCIT-A for 8 months and early special needs education as an active control for ESDM. ESDM and PCIT-A Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A) Participants in this arm receive 2 years ESDM and after 4 months PCIT-A for 8 months (see Study Protocol, Figure 2). ESDM and PCIT-A Early Start Denver Model (ESDM) intervention Participants in this arm receive 2 years ESDM and after 4 months PCIT-A for 8 months (see Study Protocol, Figure 2). Active control for ESDM and PCIT-A Early special needs education (ESNE) Participants receive early special needs education as an active control for ESDM and PCIT-A. ESDM and active control for PCIT-A 1-hour ESDM 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 ESDM and active control for PCIT-A Early Start Denver Model (ESDM) intervention 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 PCIT-A and active control for ESDM Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A) Participants receive after 4 month PCIT-A for 8 months and early special needs education as an active control for ESDM.
- Primary Outcome Measures
Name Time Method Autism symptoms change (for ESDM analysis) Between baseline to 4 month FU 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)
Disruptive behavior change (for PCIT-A analysis) Between 4-month and 12-month FU 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)
- Secondary Outcome Measures
Name Time Method Autism symptoms change (for PCIT-A analysis) Between 4-month and 24-month FU Change from 4-month to 12-month FU and to 24-month FU in Quantitative Checklist for Autism in Toddlers score (parent-reported, range: 0-100 points; higher scores mean a worse outcome)
Developmental level change (for PCIT-A analysis) Between 4-month and 24-month FU Change from 4-month to 12-month and to 24-month FU in Entwicklungstest für Kinder von 6 Monaten bis 6 Jahren (engl.: Developmental Test for Children from 6 months to 6 years; behavioral and parent-reported measure, composite score of all 6 domains; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Autism symptoms long-term change (for ESDM analysis) Between baseline and 12-month FU Change from baseline to 12-month FU in Quantitative Checklist for Autism in Toddlers score (parent-reported, range: 0-100 points; higher scores mean a worse outcome)
Developmental level change (for ESDM analysis) Between baseline and 12-month FU Change from baseline to 4-month FU and from baseline to 12-month FU in Entwicklungstest für Kinder von 6 Monaten bis 6 Jahren (engl.: Developmental Test for Children from 6 months to 6 years; behavioral and parent-reported measure, composite score of all 6 domains; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Disruptive behavior long-term change (for PCIT-A analysis) Between 4-month and 24-month FU Change from 4-month to 24-month 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)
Non-verbal Intelligence change (for PCIT-A analysis) Between 4-month and 24-month FU Change from 4-month to 12-month and to 24-month FU in Snijders-Oomen Non-verbal intelligence test revised 2-8 - puzzle subtest; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Disruptive behavior change (for ESDM analysis) Between baseline and 12-month FU Change from baseline to 4-month FU and from baseline to 12-month 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)
Adaptive behavior change (for ESDM analysis) Between baseline and 12-month FU Change from baseline to 4-month FU and from baseline to 12-month FU in Vineland Adaptive Behavior Scale (composite score of the three domains communication, daily living skills, socialization; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Adaptive behavior change (for PCIT-A analysis) Between 4-month and 24-month FU Change from 4-month to 12-month and to 24-month FU in Vineland Adaptive Behavior Scale (composite score of the three domains communication, daily living skills, socialization; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Social-emotional competence change (for PCIT-A analysis) Between 4-month and 24-month FU Change from 4-month to 12-month and to 24-month FU in Devereux Early Childhood Assessment (18 to 36 months version; (composite score of the three domains attachement/relationships, initiative, self-regulation; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Parenting stress change (for PCIT-A analysis) Between 4-month and 24-month FU Change from 4-month to 12-month FU and to 24-month FU in Eltern-Belastungs-Inventar (engl.: Parenting Stress Index; composite score of 12 subscales, z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a worse outcome)
Non-verbal intelligence change (for ESDM analysis) Between baseline and 12-month FU Change from baseline to 4-month FU and from baseline to 12-month FU in Snijders-Oomen Non-verbal intelligence test revised 2-8 - puzzle subtest; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Social-emotional competence change (for ESDM analysis) Between baseline and 12-month FU Change from baseline to 4-month FU and from baseline to 12-month FU in Devereux Early Childhood Assessment (18 to 36 months version; (composite score of the three domains attachement/relationships, initiative, self-regulation; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Parenting stress change (for ESDM analysis) Between baseline and 12-month FU Change from baseline to 4-month FU and from baseline to 12-month FU in Eltern-Belastungs-Inventar (engl.: Parenting Stress Index; composite score of 12 subscales, z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a worse outcome)
Trial Locations
- Locations (1)
Psychiatric Services of Thurgovia
🇨🇭Münsterlingen, Thurgau, Switzerland