Autism Spectrum Disorder
Conditions
Keywords
Autism, Naturalistic Developmental Behavioral Intervention, Effectiveness
Brief summary
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.
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 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.
Interventions
BEHAVIORALGroup-based Naturalistic Developmental Behavioral Intervention
Naturalistic Developmental Behavioral Intervention (Utilized NDBI-Fi as the fidelity criteria of the intervention) provided in a group setting.
BEHAVIORALOne-on-one Naturalistic Developmental Behavioral Intervention
Naturalistic Developmental Behavioral Intervention (Utilized NDBI-Fi as the fidelity criteria of the intervention) provided in an one-on-one setting
BEHAVIORALASD Diagnosis
Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* clinically diagnosed as Autism Spectrum Disorder * aged 2-6 years old * one of caregivers is able to participate treatment sessions.
Exclusion criteria
* having other major diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
| Treatment fidelity | 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 | 5 minutes | The attendance rate is used to evaluate the acceptability of the program for participating families |
| The completion of the assessment | 5 minutes | The completion of the assessment would be investigated by checking whether all the outcome measures are completed by the assessors or caregivers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Taiwan
Outcome results
None listed