Investigation of Effectiveness of an Intensive Caregiver-involved Group- Based Naturalistic Developmental Behavioral Intervention Program for Autistic Preschoolers- A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Autism Parenting Stress Index
研究概览
简要总结
This is a study that investigate the feasibility, acceptability, and preliminary efficacy of NDBIs for autistic preschoolers delivered in a group-setting. The outcome measures assess the improvements in autistic symptoms, social communication, play skills, group behaviors, adaptation, and parent stress.
详细描述
Autism spectrum disorder (ASD) is characterized by persistent social communication deficits and restricted behaviors. Global prevalence is 1-2%, with 1% in Taiwan. Social interaction obstacles and repetitive behaviors impact ASD individuals in various contexts, emphasizing the need for effective interventions. Current treatments focus on behavioral approaches, particularly Naturalistic Developmental Behavioral Interventions (NDBIs). NDBIs improve social engagement, cognitive development, and language skills. Parent-mediated intervention (PMI) enhances treatment effectiveness and reduces parenting stress. However, many NDBIs are conducted in one-on-one settings, limiting feasibility, especially in schools. Group-based interventions are beneficial and more feasible in the communities, but limited research exists. In Taiwan, early interventions, covered by National Health Insurance, lack intensity and parent involvement. The study aims to establish an intensive, parent-involved, group-based NDBIs program. The pilot randomized controlled trial will assess its feasibility, acceptability, and preliminary efficacy in improving autistic symptoms, social and play skills, group behaviors, general adaptation, and reducing parenting stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically diagnosed as Autism Spectrum Disorder
- •aged 2-6 years old
- •one of caregivers is able to participate treatment sessions.
排除标准
- •having other major diseases.
研究组 & 干预措施
experimental group
ASD preschoolers who receive group-based NDBIs intervention (aged 2-6y)
干预措施: Group-based Naturalistic Developmental Behavioral Intervention (Behavioral)
experimental group
ASD preschoolers who receive group-based NDBIs intervention (aged 2-6y)
干预措施: ASD Diagnosis (Behavioral)
active control group
ASD preschoolers who receive one-on-one NDBIs intervention (aged 2-6y)
干预措施: One-on-one Naturalistic Developmental Behavioral Intervention (Behavioral)
active control group
ASD preschoolers who receive one-on-one NDBIs intervention (aged 2-6y)
干预措施: ASD Diagnosis (Behavioral)
结局指标
主要结局
Autism Parenting Stress Index
时间窗: 5 minutes
This questionnaire is used to gauge parental stress from the perspective of parents or caregivers of young children with autism. The test items are grouped into three categories: fundamental social difficulties (item 1,2,11,12,13), challenging behavior management (item 3,4,5,6), and physical concerns (item 7,8,9,10). The total score ranges from 0 to 52, with 0 indicating not stressful, 1 indicating sometimes creates stress, 2 indicating often creates stress, 3 indicating very stressful on a daily basis, and 5 indicating so stressful sometimes we feel we can't cope.
Mullen Early Scale Learning
时间窗: 50 minutes
A comprehensive measure of cognitive functioning for infants and preschool children from birth to 68 months, consisting of five subscales: gross motor, visual reception, fine motor, receptive language, and expressive language. The maximum raw score is 50 and will be transformed into T score based on the child's age, which can then be used to determine the percentile rank and scale age equivalent.
Structured Play Assessment
时间窗: 30 minutes
A semi-structured assessment used to measure children's spontaneous play acts. The two indicators are the play diversity and the play complexity. The play acts are hierarchically ordered into 16 play levels. Play diversity represents the number of types of play acts are displayed, while play complexity refers to the highest level of the child's play acts.
Preschool and Kindergarten Behavior Scale-Second Edition
时间窗: 15 minutes
It is a parent-report or teacher-report questionnaire targeting young children's behaviors in preschools, consisting of social skills scale and problem behavior scale. The social skills scale consists of 34 likert-scaled item (0-3), with a higher score indicating better social skills. The problem behavior scale consists of 42 likert-scaled item (0-3), with a higher score indicating more severe problem behaviors.
Autism Treatment Evaluation Checklist
时间窗: 10 minutes
The Autism Treatment Evaluation Checklist (ATEC) is a tool with 77 items (likert-scaled 0-3) designed to evaluate treatment effectiveness for individuals with autism. It comprises four subscales: Speech/Language Communication, Sociability, Sensory/Cognitive Awareness, and Health/Physical Behavior. The reduced scores represented the improvement in these areas.The total score of the ATEC ranges from 0 to 180, with a higher score indicating greater severity of autism symptoms.
Vineland Adaptive Behavior Scales - Third Edition, Chinese Version (VABS-3)
时间窗: 20 minutes
It is a widely used and well validated measurement for assessing adaptive behaviors in individuals, rated by caregivers and teachers. It consists of 4 domains: communication, daily living skills, socialization, and motor skills. These domains encompass 11 subdomains, including receptive, expressive, written, personal, domestic, community, interpersonal relationships, play and leisure, coping skills, gross motor, and fine motor. The raw scores will be transformed to standard score ranged from 20 to 140 with a higher number representing better adaptation.
Family Empowerment Scale
时间窗: 5 minutes
It is a 5-point caregiver-reported questionnaire consisting of 34 items, which is used to measure the family empowerment in caregiving for children with special needs. The score ranges from 34-170, with a higher score representing a high level of empowerment.
Individual Growth and Development Indicators
时间窗: 15 minutes
A play-based observational measure assessing communication, motor function, sociability, and problem solving in toddlers. In this study, we will use the subscale sociability (Early social indicator). The ESI lasts for 6-minutes while key communication skills and social skills will be counted as number, the rate of key skills (per-minute) will be generated and used for analysis.
Treatment fidelity
时间窗: 10 minutes
The treatment fidelity is used to assess the feasibility of the program. A 10-minutes clip of the treatment session will be coded according to NDBI-Fi or adapted NDBI-Fi.
Attendance rate
时间窗: 5 minutes
The attendance rate is used to evaluate the acceptability of the program for participating families
The completion of the assessment
时间窗: 5 minutes
The completion of the assessment would be investigated by checking whether all the outcome measures are completed by the assessors or caregivers.
次要结局
- Repetitive Behavior Scale-Revised(10 minutes)
- Assessment of Preschool Children's Participation(20 minutes)
- Autism Stigma and Knowledge Questionnaire(10 minutes)
- Child Behavior Checklist(20 minutes)
- Autism Treatment Evaluation Checklist(10 minutes)
- Family Empowerment Scale(5 minutes)
- Autism Parenting Stress Index(5 minutes)