Effectiveness of Caregiver-involved Group-based NDBIs Intervention for Autistic Preschoolers
- Conditions
- Autism Spectrum Disorder
- Interventions
- Behavioral: One-on-one Naturalistic Developmental Behavioral InterventionBehavioral: Group-based Naturalistic Developmental Behavioral InterventionBehavioral: ASD Diagnosis
- Registration Number
- NCT06221943
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
This is a study that investigate the effectiveness of NDBIs for autistic preschoolers delivered in group-settings and one-on-one settings. The outcome measures assess the improvements in autistic symptoms, social communication, play skills, group behaviors, adaptation, and parent stress.
- Detailed Description
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 randomized controlled trial will assess its effectiveness in improving autistic symptoms, social and play skills, group behaviors, general adaptation, and reducing parenting stress.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- clinically diagnosed as Autism Spectrum Disorder
- aged 2-6 years old
- one of caregivers is able to participate treatment sessions.
- having other major diseases.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description active control group One-on-one Naturalistic Developmental Behavioral Intervention ASD preschoolers who receive one-on-one NDBIs intervention (aged 2-6y) experimental group ASD Diagnosis ASD preschoolers who receive group-based NDBIs intervention (aged 2-6y) active control group ASD Diagnosis ASD preschoolers who receive one-on-one NDBIs intervention (aged 2-6y) experimental group Group-based Naturalistic Developmental Behavioral Intervention ASD preschoolers who receive group-based NDBIs intervention (aged 2-6y)
- Primary Outcome Measures
Name Time Method Autism Parenting Stress Index 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 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 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 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 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) 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 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 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 of communication (Early communication indicator) and sociability (Early social indicator). Each measure 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.
- Secondary Outcome Measures
Name Time Method Repetitive Behavior Scale-Revised 10 minutes It is a tool used to assess repetitive behaviors in individuals with autism spectrum disorder. It includes 43 items (likert-scaled 0-3) divided into six subscales: Stereotyped Behavior, Self-Injurious Behavior, Compulsive Behavior, Ritualistic Behavior, Sameness Behavior, and Restricted Interests, offering a comprehensive evaluation of repetitive behaviors.
Assessment of Preschool Children's Participation 20 minutes It measures participation in children aged 2 to 5 years and 11 months. It captures involvement in play, skill development, active physical recreation, and social activities, providing a comprehensive view of their engagement in these crucial developmental areas. It assesses the diversity and frequency of the participated activities.
Autism Stigma and Knowledge Questionnaire 10 minutes This questionnaire assesses public perceptions and understanding of autism. It includes 49 items measuring stigma, misconceptions, and accurate knowledge about autism spectrum disorder. Parents will indicate their agreement or disagreement with each statement. Of these items, 30 are correct statements, and 19 are incorrect statements, helping identify areas where educational interventions are needed to improve awareness and reduce stigma in the community.
Child Behavior Checklist 20 minutes This parent-reported questionnaire is a comprehensive assessment tool for identifying behavioral and emotional problems in children. It includes 100 items (scored 0-3) covering multiple domains such as anxiety, depression, social issues, and aggressive behavior, providing a detailed profile of the child's psychological functioning. The score ranges from 0-200, with a higher score representing higher concern of behavior problems.
Trial Locations
- Locations (1)
National Taiwan University Hospital Yunlin Branch
🇨🇳Douliu, Taiwan