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)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Autism symptoms change (for ESDM analysis)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The DPICS rating - as part of the primary outcome - is the only measure that is masked
入排标准
- 年龄范围
- 24 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Insufficient German language skills of both parents to participate in the intervention
- •Severe hearing or visual impairment
- •Attention deficit hyperactivity disorder
- •Rett syndrome
- •Other rare, severe neurological disorders that interfere with therapy
结局指标
主要结局
Autism symptoms change (for ESDM analysis)
时间窗: 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)
时间窗: 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)
次要结局
- 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)
- Autism symptoms long-term change (for ESDM analysis)(Between baseline and 12-month FU)
- Developmental level change (for ESDM analysis)(Between baseline and 12-month FU)
- Disruptive behavior long-term 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)
- Disruptive behavior change (for ESDM analysis)(Between baseline and 12-month FU)
- Adaptive behavior change (for ESDM analysis)(Between baseline and 12-month FU)
- Adaptive behavior change (for PCIT-A analysis)(Between 4-month and 24-month FU)
- Social-emotional competence change (for PCIT-A analysis)(Between 4-month and 24-month FU)
- Parenting stress change (for PCIT-A analysis)(Between 4-month and 24-month FU)
- Non-verbal intelligence change (for ESDM analysis)(Between baseline and 12-month FU)
- Social-emotional competence change (for ESDM analysis)(Between baseline and 12-month FU)
- Parenting stress change (for ESDM analysis)(Between baseline and 12-month FU)
研究者
Bruno Rhiner
Head of Child and Adolescent Psychiatry
Psychiatrische Dienste Thurgau