UMIN-CTR Clinical Trial

Public title

Services children with autism spectrum disorder receive: what improves participation?

Acronym

Services children with autism spectrum disorder receive: what improves participation?

Scientific Title

Examining Service Factors Affecting Participation of Children with Autism Spectrum Disorders by Propensity Scores

Scientific Title:Acronym

Examining Service Factors Affecting Participation of Children with Autism Spectrum Disorders by Propensity Scores

Region

Japan

Condition

Preschoolers with autism spectrum disorder

Classification by specialty

Not applicable

Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The main objective of this study is to determine whether various types of support services received by young children with autism spectrum disorder improve participation. In particular, this study will use propensity scores to analyze the impact of occupational therapists' involvement on children's participation. Through this study, we aim to provide knowledge to develop a more effective support system for children with autism.

Basic objectives2

Others

Basic objectives -Others

The second objective of this study is to examine what classes Children's Participation and Mental Health fall into and how they vary through latent transfer analysis of the Family Outcome Surveys (FOS) and the Strength and Difficulties Questionnaire (SDQ), respectively, and to identify factors that influence them. A third objective is to examine the longitudinal measurement properties of the PQP.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Participation Questionnaire for Preschoolers

Key secondary outcomes

Strength and Difficulties Questionnaire
Items related to developmental coordination disorder (DCD) in the Check List of obscure disAbilitieS in Preschoolers (CLASP)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

51

months-old

<=

Age-upper limit

75

months-old

>=

Gender

Male and Female

Key inclusion criteria

(1) have not received a diagnosis of any neurodevelopmental disorders other than those being studied
(2) have an Intelligence Quotient (IQ) of 50 or higher as measured by the Wechsler Intelligence Scale for Children, the Wechsler Preschool and Primary Scale of Intelligence, or the Tanaka-Binet Intelligence Scale, or have a Developmental Quotient (DQ) of 50 or higher on the Kyoto Scale of Psychological Development.

Key exclusion criteria

none.

Target sample size

350

Name of lead principal investigator

1st name	Takuto
Middle name
Last name	Nakamura

Organization

Kanagawa University of Human Services

Division name

School of Rehabilitation

Zip code

2388522

Address

Heiseicho1-10-1 Yokosuka city, Kanagawa prefecture

TEL

0468822804

Email

nakamura-y49@kuhs.ac.jp

Name of contact person

1st name	Takuto
Middle name
Last name	Nakamura

Organization

Kanagawa University of Human Services

Division name

School of Rehabilitation

Zip code

2388522

Address

Heiseicho1-10-1 Yokosuka city, Kanagawa prefecture

TEL

0468822804

Homepage URL

Email

nakamura-y49@kuhs.ac.jp

Institute

Kanagawa University oh Human Services

Institute

Department

Personal name

Takuto Nakamura

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board at Kanagawa University of Human Services

Address

Heiseicho1-10-1 Yokosuka city, Kanagawa prefecture

Tel

0468822804

Email

jimu-rinri@kuhs.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

04

Month

17

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

https://doi.org/10.1080/01942638.2025.2601551

Number of participants that the trial has enrolled

545

Results

Three objectives are registered. Results for the third, the longitudinal measurement properties of the PQP, are published: test-retest reliability of the total score was ICC=0.93, three of four responsiveness hypotheses were supported, and the minimal detectable change was 13.25 points. The first objective (effect of occupational therapist involvement on participation) and the second (latent transition analysis of the FOS and SDQ) are being analysed and will be posted once finalised.

Results date posted

2026

Year

09

Month

03

Day

Results Delayed

Delay expected

Results Delay Reason

A manuscript addressing the second objective, latent transition analysis, is currently under review. For the first objective, the effect of occupational therapist involvement on participation, a methodological issue was identified concerning the construction of confidence intervals for machine-learning-based estimators. The analytic approach is being finalised in consultation with the study statistician. Results for both objectives will be posted promptly once finalised.

Date of the first journal publication of results

Baseline Characteristics

The analysis cohort comprised 249 caregivers of children aged 51 to 75 months with a physician diagnosis of autism spectrum disorder. Baseline (T1) characteristics were as follows. Boys, 198 (80%); mean age, 63.9 months (SD 7.1). Level of intellectual functioning: IQ/DQ 50 to 69, 90 (36%); 70 to 84, 67 (27%); 85 to 114, 78 (31%); 115 or above, 14 (6%). Co-occurring ADHD, 53 (21%). Mean SRS-2 T score, 82.2 (SD 12.3). Mean months since diagnosis, 22.2 (SD 13.2). Among caregivers, mean K6 total score was 9.1 (SD 6.2); 152 (61%) had a college degree or above; 47 (19%) reported household income of 10 million yen or more and 19 (8%) less than 3 million yen. Baseline outcome scores were: PQP total, mean 97.5 (SD 14.9); SDQ Total Difficulties Score, mean 19.2 (SD 5.0); CLASP developmental coordination disorder items, mean 2.6 (SD 1.4); FOS-J total, mean 71.7 (SD 16.6). Service use at T1 included intervention by a psychologist in 92 (37%), by a physiotherapist in 16 (6%), and by a speech-language therapist in 127 (51%); 6 (2%) were not using child development support services.

Participant flow

A total of 545 caregivers who met the eligibility criteria at T1 were enrolled. Of these, 249 who scored at or below the mean on participation (PQP total score) and screened positive for developmental coordination disorder risk on the CLASP were included in the analysis cohort. Follow-up was completed by 214 participants at T3 (35 lost to follow-up; 85.9% retention) and by 167 at T4 (47 additional participants lost; 67.1% retention). Among the 167 who completed T4, 47 met the exposure definition (individual occupational therapy with three or more occupational therapist sessions within three months) during the T3 to T4 interval, and 120 did not.

Adverse events

This is an observational study without any intervention. No adverse events occurred in connection with the questionnaire surveys.

Outcome measures

Primary outcome: total score of the Participation Questionnaire for Preschoolers (PQP) at T4; 29 items rated on a 5-point scale, with higher scores indicating better participation.
Secondary outcomes at T4: the Strengths and Difficulties Questionnaire (SDQ) Total Difficulties Score (sum of the emotional symptoms, conduct problems, hyperactivity/inattention, and peer problems subscales; higher scores indicate greater difficulties), and the five developmental coordination disorder items of the CLASP (screened positive if any item was rated "often" or "always").

Plan to share IPD

No

IPD sharing Plan description

Individual participant data will not be shared, as consent for secondary use or transfer to third parties was not obtained from participants. The study protocol and analysis code are available from the principal investigator upon reasonable request.

Recruitment status

No longer recruiting

Date of protocol fixation

2023

Year

06

Month

15

Day

Date of IRB

2023

Year

06

Month

15

Day

Anticipated trial start date

2023

Year

07

Month

30

Day

Last follow-up date

2024

Year

03

Month

10

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

We are requesting responses from 350 caregivers of children with autism spectrum disorder aged 48-71 months at four different points in time. Initially, participants are asked to complete the PQP, Demographic Questionnaire, SDQ, FOS-J, and GRC. The second data collection occurs one week after the first, including PQP, GRC, and SRS-2. The third collection, three months after the second, requests responses to PQP, SDQ, GRC, FOS-J, and Demographic Questionnaire. The fourth collection, three months after the third, involves PQP, SDQ, FOS-J, and GRC. Test-retest reliability is verified by calculating the intraclass correlation coefficients for PQP between the first and second surveys for participants who reported "no change" in GRC. Responsiveness is assessed by correlating changes in PQP scores with changes in the SDQ subdomains of Total Difficulties, Prosocial Behavior, Peer Relationship Problems, and the total score of FOS-J. Additionally, minimal important change (MIC) is determined using ROC curves for PQP and GRC. Furthermore, latent transition analyses are conducted based on the scores of each factor of PQP and SDQ to verify the transition probabilities among classes from the first to the fourth survey.Finally, using the PQP, the demographic questionnaire, the SRS-2, the SDQ, and the FOS-J, we will adjust for confounders and estimate the mean differences in the PQP scores, SDQ scores, and the item related to developmental coordination disorder from the Check List of obscure disAbilitieS in Preschoolers at T4 between the group that received occupational therapy and the group that did not receive it from T3 to T4, by applying sequential G-computation with SuperLearner combined with inverse probability of censoring weighting (IPCW).

Registered date

2024

Year

04

Month

16

Day

Last modified on

2026

Year

09

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060776