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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | ASD preschoolers who receive group-based NDBIs intervention (aged 2-6y) |
|
| active control group | Active Comparator | ASD preschoolers who receive one-on-one NDBIs intervention (aged 2-6y) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group-based Naturalistic Developmental Behavioral Intervention | Behavioral | Naturalistic Developmental Behavioral Intervention (Utilized NDBI-Fi as the fidelity criteria of the intervention) provided in a group setting. |
| Measure | Description | Time Frame |
|---|---|---|
| Mullen Early Scale Learning | 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. | 50 minutes |
| Individual Growth and Development Indicators | 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. | 15 minutes |
| Vineland Adaptive Behavior Scales - Third Edition, Chinese Version (VABS-3) | 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. | 20 minutes |
| Treatment fidelity | 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. | 10 minutes |
| Attendance rate |
| Measure | Description | Time Frame |
|---|---|---|
| Child Behavior Checklist | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Structured Play Assessment | Structured Play assessment is a semi-structured assessment used to measure children's spontaneous play acts. The assessor will interact with the child following a structured play routine and evaluate the play actions. 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital Yunlin Branch | Douliu | Taiwan |
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| One-on-one Naturalistic Developmental Behavioral Intervention | Behavioral | Naturalistic Developmental Behavioral Intervention (Utilized NDBI-Fi as the fidelity criteria of the intervention) provided in an one-on-one setting |
|
| ASD Diagnosis | Behavioral | Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS) |
|
The attendance rate is used to evaluate the acceptability of the program for participating families
| 5 minutes |
| The completion of the assessment | The completion of the assessment would be investigated by checking whether all the outcome measures are completed by the assessors or caregivers. | 5 minutes |
| 20 minutes |
| Autism Treatment Evaluation Checklist | 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. | 10 minutes |
| Family Empowerment Scale | 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. | 5 minutes |
| Autism Parenting Stress Index | 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. | 5 minutes |
| 30 minutes |
| Repetitive Behavior Scale-Revised | 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. | 10 minutes |
| Assessment of Preschool Children's Participation | This questionnaire 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. | 20 minutes |
| Preschool and Kindergarten Behavior Scale-Second Edition | 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. | 15 minutes |
| Autism Stigma and Knowledge Questionnaire | 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. | 10 minutes |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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