Autism Spectrum DisorderNCT06221943
Effectiveness of Caregiver-involved Group-based NDBIs Intervention for Autistic Preschoolers
A study testing Group-based Naturalistic Developmental Behavioral Intervention, One-on-one Naturalistic Developmental Behavioral Intervention and ASD Diagnosis in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Group-based Naturalistic Developmental Behavioral Intervention, One-on-one Naturalistic Developmental Behavioral Intervention and ASD Diagnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinically diagnosed as Autism Spectrum Disorder
- aged 2-6 years old
- one of caregivers is able to participate treatment sessions.
Who cannot join
- having other major diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Effectiveness of an Intensive Caregiver-involved Group- Based Naturalistic Developmental Behavioral Intervention Program for Autistic Preschoolers- A Pilot Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Group-based Naturalistic Developmental Behavioral Intervention, One-on-one Naturalistic Developmental Behavioral Intervention, ASD Diagnosis
- Keywords
- Autism, Naturalistic Developmental Behavioral Intervention, Effectiveness
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based Naturalistic Developmental Behavioral InterventionBehavioural
Naturalistic Developmental Behavioral Intervention (Utilized NDBI-Fi as the fidelity criteria of the intervention) provided in a group setting.
One-on-one Naturalistic Developmental Behavioral InterventionBehavioural
Naturalistic Developmental Behavioral Intervention (Utilized NDBI-Fi as the fidelity criteria of the intervention) provided in an one-on-one setting
ASD DiagnosisBehavioural
Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | ASD preschoolers who receive group-based NDBIs intervention (aged 2-6y) Receives: Behavioral: Group-based Naturalistic Developmental Behavioral Intervention; Behavioral: ASD Diagnosis |
| active control group | Active comparator | ASD preschoolers who receive one-on-one NDBIs intervention (aged 2-6y) Receives: Behavioral: One-on-one Naturalistic Developmental Behavioral Intervention; Behavioral: ASD Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 10 minutes
Attendance rate
The attendance rate is used to evaluate the acceptability of the program for participating families
Measured: 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.
Measured: 5 minutes
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jan 2024
- Primary completion20 Mar 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221943
- Sponsor's protocol ID
- 202310088RIND
- Status last verified
- Sep 2025
- First submitted
- 15 Jan 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seng GJ, Lin JY, Huang WL, Lai HY, Kao WC, Chen HL, Gau SS. Feasibility and Preliminary Efficacy of a Caregiver-Assisted Group-Based Naturalistic Developmental Behavioral Intervention Program for Autistic Preschoolers: A Pilot Randomized Controlled Trial. Autism. 2026 Sep;30(9):2208-2224. doi: 10.1177/13623613261462574. Epub 2026 Jul 23.
PubMed 42494078
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Effectiveness of an Intensive Caregiver-involved Group- Based Naturalistic Developmental Behavioral Intervention Program for Autistic Preschoolers- A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06221943
- Acronym / sponsor ID
- 202310088RIND
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism, Naturalistic Developmental Behavioral Intervention, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Behavioral: Group-based Naturalistic Developmental Behavioral Intervention, Behavioral: ASD DiagnosisASD preschoolers who receive group-based NDBIs intervention (aged 2-6y) |
| active control group | Active comparator | Behavioral: One-on-one Naturalistic Developmental Behavioral Intervention, Behavioral: ASD DiagnosisASD preschoolers who receive one-on-one NDBIs intervention (aged 2-6y) |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- clinically diagnosed as Autism Spectrum Disorder
- aged 2-6 years old
- one of caregivers is able to participate treatment sessions.
Key exclusion criteria (1 listed)
- having other major diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group-based Naturalistic Developmental Behavioral InterventionNaturalistic Developmental Behavioral Intervention (Utilized NDBI-Fi as the fidelity criteria of the intervention) provided in a group setting. | Behavioural | experimental group |
| One-on-one Naturalistic Developmental Behavioral InterventionNaturalistic Developmental Behavioral Intervention (Utilized NDBI-Fi as the fidelity criteria of the intervention) provided in an one-on-one setting | Behavioural | active control group |
| ASD DiagnosisAutism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS) | Behavioural | active control group, experimental group |
Primary outcome
Mullen Early Scale Learning
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 5 minutes
The attendance rate is used to evaluate the acceptability of the program for participating families
The completion of the assessment
Time frame: 5 minutes
The completion of the assessment would be investigated by checking whether all the outcome measures are completed by the assessors or caregivers.
4 secondary outcomes
Child Behavior Checklist
Time frame: 20 minutes
Autism Treatment Evaluation Checklist
Time frame: 10 minutes
Family Empowerment Scale
Time frame: 5 minutes
Autism Parenting Stress Index
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Derived from this study: PubMed 42494078Seng GJ, Lin JY, Huang WL, Lai HY, Kao WC, Chen HL, Gau SS. Feasibility and Preliminary Efficacy of a Caregiver-Assisted Group-Based Naturalistic Developmental Behavioral Intervention Program for Autistic Preschoolers: A Pilot Randomized Controlled Trial. Autism. 2026 Sep;30(9):2208-2224. doi: 10.1177/13623613261462574. Epub 2026 Jul 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based Naturalistic Developmental Behavioral Intervention, One-on-one Naturalistic Developmental Behavioral Intervention and ASD Diagnosis in people with Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mullen Early Scale Learning (time frame: 50 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06221943, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.