Study protocol for a multi-centre randomised controlled trial of the Thai early intervention for autism: Assistive Technology for Caregivers (TEI4A-ATC) across nine hospitals in health region 1, northern Thailand

Abstract

Introduction

The management of autism spectrum disorder (ASD) involves a varied and comprehensive range of support services at various stages of an autistic individual’s life. In Thailand, parents/legal guardians of children with ASD often encounter challenges such as difficulty travelling from rural areas to access support services. The aim of the present study is to investigate the effectiveness of a computer-based intervention programme for caregivers of children with ASD called the Thai Early Intervention for Autism—Assistive Technology for Caregivers (TEI4A-ATC), designed and implemented by a multidisciplinary team.

Method and analysis

160 children and their caregivers are being recruited. They will be randomised 1:1 into two treatment arms: access to TEI4A-ATC for the intervention group and standard care for the control group. Before enrolment, ASD diagnosis will be conducted using the Thai Diagnostic Autism Scale: children’s ASD scores will be determined using the Thai Autism Treatment Evaluation Checklist for evaluating communication, sociability and sensory/cognitive awareness and the Thai Early Developmental Assessment for Intervention for evaluating motor skills, social interaction, language development and problem-solving. Both assessment tools will be used again after 3 months of treatment. Similarly, the caregivers’ knowledge, attitude and practice (KAP) for ASD care will be assessed using a questionnaire at enrolment and again after treatment. Comparison of the children’s ASD scores and caregivers’ KAP responses between the treatment groups and before and after treatment will be performed based on the intention-to-treat principle.

Ethics and dissemination

This study was approved by the Human Research Ethics Committee for Mental Health and Psychiatry, Department of Mental Health, Ministry of Public Health (DMH.IRB.COA 037/2565). Written informed consent will be obtained from the participants prior to enrolment. The study’s findings may be disseminated through scientific publications and conference presentations. The results of the study will be shared with key stakeholders, including caregivers, psychiatrists, policymakers and the general public, via appropriate dissemination channels to aid in creating appropriate practice and policy guidelines.

Trial registration number

This study was registered with the Thai Clinical Trials Registry (TCTR20240320010) on 20 March 2024.

Correspondence to Dr Patrinee Traisathit; [email protected]

STRENGTHS AND LIMITATIONS OF THIS STUDY

• The programme designed and implemented by a multidisciplinary team provides the caregivers with clear and easy-to-understand procedures for each step of autism spectrum disorder (ASD) care in young children.

• Analysing caregivers’ knowledge, attitude and practice regarding the programme and ASD, alongside pretreatment and post-treatment outcomes for the children, may highlight the advantages of a comprehensive caregiver training programme.

• The adequacy of engagement, which may influence variations in children’s outcomes and the caregivers' practices, will be assessed by evaluating the caregivers’ adherence to the programme.

• Participants will be recruited solely from the northern region of Thailand, so their characteristics may be different from individuals in other parts of Thailand.

• Since the programme is registered and implemented using the Line application, some participants in rural areas may lack internet-accessible devices, so they may be unable to participate in this programme.

Introduction

Autism spectrum disorder (ASD) is a pervasive neurodevelopmental disorder characterised by serious deficits in verbal and non-verbal communication and social interaction, as well as restricted and/or repetitive patterns of behaviour and interest.¹ Early identification of ASD and initiation of specialised treatment is imperative since starting the latter as early as 18 months old can lead to better long-term outcomes in the child in terms of functioning in society and family life.^2–4 The current prevalence of ASD among children globally is 10 per 1000.⁵ In Thailand, the prevalence of ASD among children aged 2–5 years of age in 2022 was 6 per 1000 children (16 892 of 2 814 823 children nationwide). Unfortunately, accessing early screening, diagnosis and services for ASD in young children in Thailand is problematic, with only 57.83% of them aged less than 5 years old having access.⁶

There are multiple barriers to diagnosis and intervention programmes, such as time-consuming evaluation, cost of care, as well as a lack of primary care providers and/or their reluctance to perform ASD diagnosis.⁷ In 2018, the Rajanagarindra Institute of Child Development (RICD) developed a new innovative diagnostic tool called the Thai Diagnostic Autism Scale (TDAS) for the early diagnosis of ASD in Thai children aged 12–48 months old, which constituted a major advancement in early diagnosis. TDAS was developed based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM‐5), which is the current gold standard for identifying ASD used by specialists in the fields of child and adolescent psychiatry, paediatrics and general psychiatry. Tangviriyapaiboon et al⁸ reported that TDAS showed high sensitivity and specificity for ASD identification (100% and 82.4%, respectively), along with excellent diagnostic agreement between TDAS and the evaluators, as well as between TDAS and the physicians’ diagnoses. Therefore, the psychometric properties of this diagnostic tool make it reliable and suitable for the early diagnosis of and subsequent intervention for ASD.

The process of obtaining an accurate ASD diagnosis and engaging in treatment involves several complex steps that often include visits to a primary healthcare provider for screening and then to a subspecialist for diagnosis.⁹ Thus, access to ASD diagnosis and intervention by a qualified professional is needed to effectively diagnose and treat ASD.^{4 10} In Thailand, the early detection of and intervention for ASD are challenging due to a paucity of ASD specialists and the lack of access to healthcare and treatment due to parents or legal guardians not being able to afford the regular treatment and transportation costs to the clinic. However, care by caregivers combined with the existing clinical knowledge concerning ASD-specific strategies in the home and other settings could be especially effective in helping children with ASD learn new skills, reduce maladaptive behaviour and become more motivated to interact with strangers.

Several computer-based intervention (CBI) programmes such as Help is in Your Hands, Therapy Outcomes By You,¹¹ Behavioral Intervention in Autism,¹² ImPACT Online,¹³ Pivotal Response Treatment,¹⁴ Secret Agent Society and Central Intelligence Agency,¹⁵ Online Parent Training in Early Behavioral Intervention,¹⁶ Parent Education and Training¹⁷ and TrASDition Training,¹⁸ among others, have been developed and implemented in several settings. Although the use of a CBI programme in the treatment of ASD has shown some advantages over traditional care programmes, including on-demand access that fits families’ schedules, automation of certain therapy components to reduce in-person sessions and overall costs, standardised delivery for consistent treatment fidelity, adaptive content tailored to each child’s learning pace, real-time progress monitoring with immediate feedback and built-in parent-training modules to help caregivers develop skills into daily routines, there are still some practical limitations such as limited access to the internet or online programmes, inappropriate content in the programme and no pretreatment and post-treatment comparisons of the knowledge, attitude and practice components of the programme. Therefore, our research team consisting of experts from multiple disciplines such as paediatrics, psychology, statistics, computer programming and physical education designed the Thai Early Intervention for Autism—Assistive Technology for Caregivers (TEI4A-ATC) programme to provide comprehensive support for the caregivers of children diagnosed with ASD. This includes on-demand access to video-guided exercise modules with step-by-step instructions, automated scheduling and reminder tools to optimise time efficiency and adherence and secure messaging and teleconsultation channels for prompt guidance by our specialists.

The TEI4A-ATC programme used in this prospective study is an assistive approach designed specifically for caregivers of children diagnosed with ASD who cannot or find it difficult to access appropriate healthcare. The activities designed to cover the various levels of ASD severity are presented to the child as videos that are administered by the caregiver at the appropriate level for the child. In summary, the central theme of this study is to investigate the efficiency of utilising the TEI4A-ATC on young children aged 12–60 months old diagnosed with ASD and explore the knowledge, attitude and practice (KAP) of caregivers of children diagnosed with ASD.

Objectives

Primary objective

The primary objective of this study is to determine the efficacy of the TEI4A-ATC compared with standard care treatment in mitigating ASD severity after 3 months of treatment.

Hypothesis 1

The TEI4A-ATC programme is an effective tool for caregivers to stimulate developmental progress in children with ASD. This will be measured by using the combined scores for the Thai Autism Treatment Evaluation Checklist (ATEC) and the Thai Early Developmental Assessment for Intervention (TEDA4I) after 3 months of stimulation using the TEI4A-ATC-based or standard treatment.

Secondary objectives

These include evaluating the KAP of the caregivers of children diagnosed with ASD before and after participating in the training programme.

Hypothesis 2

The TEI4A-ATC improves the knowledge of ASD of the caregivers compared with standard treatment.

Hypothesis 3

The TEI4A-ATC improves the attitude of the caregivers towards ASD compared with standard treatment.

Hypothesis 4

The TEI4A-ATC enhances the practice of the caregivers concerning ASD treatment compared with standard treatment.

Hypothesis 5

The caregivers will adhere to the TEI4A-ATC during the 3 months of stimulation.

Methods and analysis

Study design

This is a multicentre, randomised, single-blinded, phase II study comprising 160 young children with ASD who will receive developmental stimulation therapy for 3 months. They will be randomly assigned to the intervention group receiving care via the TEI4A-ATC programme or the control group receiving standard care following the current guidelines in Thailand.

Although an intensive intervention (20–40 hours per week) has been suggested as being more effective than a non-intensive intervention (10 hours per week),^19–21 it requires suitable professionals in a hospital setting during the training period. A previous study into a home developmental stimulation programme for Thai children with ASD (THAI Model) that provides activities for children and caregivers for at least 10 hours per week demonstrated improved child development and caregivers’ communication and practical skills.²² In addition, the stress levels of the caregivers were reduced by the end of the programme. Therefore, the investigators designed the TEI4A-ATC as a 10-hour non-intensive programme that is more appropriate for caregivers in a home setting.

The KAPs of both groups of caregivers will be preliminarily tested before presenting the programme to them and then again afterwards. The behavioural, functional and neurocognitive abilities of the children to identify the severity of ASD prior to treatment will be assessed by an experienced psychologist (figure 1). All analyses will be performed according to the intention-to-treat principle.

Figure 1. Flow chart of the programme assessment and assignment. ATEC, Thai Autism Treatment Evaluation Checklist; TDAS, Thai Diagnostic Autism Scale; TEDA4I, Thai Early Developmental Assessment for Intervention.

Recruitment and study procedures

Participants will consist of children aged 12–60 months old who have received a formal diagnosis of ASD. Recruitment will start on 19 June 2024 at nine hospitals within Health Region 1 covering eight provinces in northern Thailand. The study is planned to be completed by April 2025. All eligible participants will be assigned to either the TEI4A-ATC or standard care group. Written informed consent will be obtained from the parents or legal guardians during the intake interview process (see online supplemental file S1).

Children and their caregivers in the standard care group will receive standard care as outlined by each hospital’s guidelines appropriate for the child’s level of ASD. In the TEI4A-ATC group, front-line healthcare providers from each hospital have been recruited as trainers for the TEI4A-ATC programme to instruct the caregivers of children diagnosed with ASD on how to apply the programme. Caregivers in this group will receive a 30 min session introducing the programme and a printout with a QR code for accessing the programme; they will be instructed to train their children for 10 hours a week over a 3-month period using videos tailored to the child’s specific level of ASD. Daily reminders to engage with the programme are sent each day at 09:00, with a follow-up reminder at 18:00 via Line Official if there is no record of programme access. Assessment of the KAP of the caregivers in both groups will be carried out before commencement of the study and afterwards (figure 1). Both groups will be required to return to the hospital after 3 months for re-evaluation of their children’s ASD level and assessment of the caregivers' KAP concerning ASD. Figure 2 shows the Consolidated Standards of Reporting Trials flow for the recruitment of participants for the study.

Figure 2. The Consolidated Standards of Reporting Trials flow of the recruitment of participants for the study. ASD, autism spectrum disorder; ATEC, Thai Autism Treatment Evaluation Checklist; TDAS, Thai Diagnostic Autism Scale; TEDA4I, Thai Early Developmental Assessment for Intervention; TEI4A-ATC, Thai Early Intervention for Autism—Assistive Technology for Caregivers.

Inclusion criteria

• The child must be aged 12–60 months old and have been diagnosed with ASD according to the TDAS or DSM-5 criteria.

• The caregiver for the child must have provided informed consent on behalf of the child’s participation in the research.

• The child with ASD has not yet received standard treatment.

• The caregiver for the child with ASD is responsible for providing care for the child at home during the study period.

• The caregiver must be able to read, write and understand Thai.

Exclusion criteria

• Clinically relevant epileptic seizures.

• Clinically relevant visual, hearing and/or physical impairment that prohibits participation in the intervention/study.

• Absence of substantial improvement in ASD symptoms or any other medically justified rationale to discontinue treatment, as determined by a physician.

• The caregiver requests withdrawal from the study.

• The caregiver does not wish to participate in the study setting and/or prefers that their child undergo standard treatment.

Diagnosis of ASD

TDAS will be employed to verify the clinical diagnosis of ASD. This scale includes 23 items divided between observational and interview sections, with a cut-off score of ≥20.²³ It is specifically designed for the early diagnosis of ASD in Thai children aged 12–48 months. TDAS has demonstrated high diagnostic accuracy and exhibits acceptable-to-good internal consistency.⁸

Randomisation

A total of 160 children and their caregivers will be randomised in a 1:1 ratio for the two study arms: TEI4A-ATC as the intervention group and standard care as the control group using the stratified permuted block randomisation method. Randomisation will be performed by the study statisticians using computer-generated random numbers. To ensure balance between the two arms and to minimise its possible influence on the outcome, stratification will be carried out based on the severity of ASD utilising blocks of four and six with a 2:3:3 ratio. Each hospital will manage 16–18 pairs of participants. The allocation assignment has been communicated to the research coordinator and study nurses responsible for initiating the treatment protocol for the children and their caregivers.

Outcome measures

An overview of the outcome measures and assessment schedule in which they will be used is provided in table 1.

Table 1

The study outcome measures and assessment schedule

Item	Screening and randomisation	Timepoints			End of study
		1 month (±7 days)	2 months (±7 days)	3 months (±7 days)
Review eligibility criteria	✓
Informed consent form	✓
Assent form	✓
Randomisation	✓
Review demographic characteristics	✓
Thai Diagnostic Autism Scale	✓
Thai Autism Treatment Evaluation Checklist	✓			✓
Thai Early Developmental Assessment for Intervention	✓			✓
Assess the knowledge, attitude and practice of the caregivers	✓		✓	✓
Assess caregiver adherence to the Thai Early Intervention for Autism—Assistive Technology for Caregivers programme	✓	✓	✓	✓
Withdrawal					✓
Study completion					✓

Primary outcomes

The Thai ATEC (an ASD diagnostic assessment tool) has been designed for use with children aged 5–12 years old and consists of 77 items. It will be completed by the caregivers of the children with ASD.²⁴

TEDA4I is used to examine early childhood development at 9, 18, 30 and 42 months old. It is designed to identify developmental problems and specific areas of deficit.²⁵

Secondary outcomes

The KAP instrument (see online supplemental file S2) was designed by the study team to assess caregivers’ knowledge (20 items), attitudes (9 items) and practices (15 items) related to supporting their child with ASD before and after participation in the TEI4A-ATC programme. Knowledge items addressing facts and common misconceptions about ASD are formatted as dichotomous ‘yes/no’ questions. A five-point Likert scale is employed for the attitude and practice items to capture beliefs, feelings and support behaviours following assistive-technology training. To establish content validity, five ASD experts reviewed the instrument for relevance and clarity. The Scale-Content Validity Index (S-CVI) was used to quantify the content validity, thereby ensuring that each item accurately reflects a key aspect of the caregivers’ KAP. Subsequently, the instrument was pilot-tested on 21 caregivers of children with ASD to assess its internal consistency reliability. To this end, Cronbach’s alpha and Kuder–Richardson 20 (KR-20) coefficient values were calculated for the Likert-scaled items concerning attitude and dichotomous (yes/no) items concerning knowledge, respectively. Overall, the KAP instrument achieved Acceptable Content Validity ≥0.90 (S-CVI/average≥0.90; S-CVI/Universal Agreement≥0.80). The KR-20 reliability coefficient was 0.512, thus indicating moderate reliability. Revising items with extreme difficulty may enhance overall confidence in the instrument. All attitude and practice items demonstrated adequate alignment (Item-Objective Congruence>0.50; Item-Level Content Validity Index>0.78), and the overall content validity was also strong. Cronbach’s alpha values for attitude and practice were 0.71 and 0.69, respectively, which were close to an acceptable level of internal consistency (0.70–0.80).

Exploratory outcome

Caregiver adherence to the TEI4A-ATC programme, measured as the frequency at which the caregiver logs in to train the child, will be recorded by the study team throughout the 3-month intervention period to assess the adequacy of engagement.

Sample size calculation

The required sample size was calculated according to the clinical trial: superiority design utility for a randomised controlled trial procedure.²⁶ We anticipate that young children with ASD should show improvement after 3 months of receiving treatment, as assessed by using the Thai ATEC. We hypothesise that the 3-month period for the TEI4A-ATC programme will result in a reduction in Thai ATEC scores by at least five points. A minimum sample size of 69 participants for each treatment is required assuming a superiority margin of 10 points in Thai ATEC scores between the TEI4A-ATC and standard care groups, with an expected SD of 10, a power of 90%, randomised 1:1 allocation into the two groups, two-sided testing and a significance level of 5%. In addition, to account for 15% dropout or loss-to-follow-up over the study period, the estimated required sample size for this study is 80 participants per group (a total of 160 participants).

Statistical methods

Descriptive statistics will be used to summarise the demographic information and KAP levels for the TEI4A-ATC programme. The mean and SD or the median and IQR will be used as appropriate for the continuous data, whereas the frequency and percentage will be used for the categorical data. Comparison of the characteristics between the intervention and control groups will be conducted by using independent t-tests or Wilcoxon’s rank-sum tests for continuous variables and χ² or Fisher’s exact tests for categorical variables where appropriate. Statistical analyses will be performed on an intention-to-treat basis.

Evaluating the efficiency of the TEI4A-ATC programme

To this end, we will examine both within-subject effects over time and between-subject effects (the TEI4A-ATC intervention group vs the control group). We will use paired t-tests or Wilcoxon’s signed-rank tests to assess changes in ATEC scores within subjects from the baseline to 3 months of treatment. Independent t-tests or Mann-Whitney U tests will be used to compare the difference in ATEC scores between the two groups. The measurement of association will be assessed as changes in the mean ATEC scores with associated 95% CIs. A p value<0.05 will be considered as statistically significant.

Caregiver KAP assessment

Paired t-tests or signed-rank tests will be used to assess changes in KAP at the baseline, 2 months and 3 months. Independent t-tests or Mann-Whitney U tests will be used to compare differences in KAP levels between the caregivers in the two treatment groups. The measurement of association will be assessed by changes in the KAP means with the associated 95% CI. A p value<0.05 will be considered significant. Weekly adherence scores will be summarised to evaluate adherence to using the TEI4A-ATC programme. A significance level of 5% will be applied to all hypotheses, with two-sided CI estimates provided for all statistical assessments. Stratification will be incorporated into all analyses unless stated otherwise. Statistical analyses will be performed using STATA software.

Data collection and management

The Department of Statistics, Faculty of Science, Chiang Mai University, is being used as the coordinating centre for this study. Staff therein will prepare the study-related documents and are responsible for data analysis and reporting, including data cleaning and addressing queries. The study-related documents will be kept in locked cabinets and/or in password-protected files and computers. Case report forms (CRFs) will be used for initial data collection at each site and then electronically transferred to the RICD. Subsequent CRFs are to be electronically transferred to the RICD study coordinating centre within 14 business days after each visit, and an investigator will verify the CRF before transfer. All reporting and publication of data gathered for this study are under the authority of the principal investigator and RICD.

Confidentiality and incentivisation

The personal details of each child and their caregiver will not be revealed. If videos or photos of the training sessions are taken, the child’s face will be blurred therein to ensure that they are unrecognisable. All evaluation forms and other records can only be identified via a coded number to maintain participant confidentiality. All records will be kept in a secure area. Data retrieval will be conducted using the coded numbers only. Clinical information will not be released without prior written permission from the subject’s legal guardian.

Although participants will not receive payment for taking part in this study, they may receive compensation for travel costs, the amount of which will be commensurate with and determined by each site.

Unblinding

The study is single-blinded, meaning that the principal investigator/research assistants who facilitate the outcome assessments will be kept blinded regarding randomisation and allocation of the participants. Participants will be regularly instructed not to tell the evaluators which group they are allocated to.

Patient and public involvement

None.

Discussion

The early detection and intervention of ASD are persistently challenging in Thailand for a variety of reasons. In addition to a paucity of ASD specialists, difficulty in accessing healthcare and treatment due to the expense of regular treatment and transportation costs to the clinic are the main barriers. Enhancing the care administered by caregivers combined with the existing knowledge about ASD-specific strategies in the home and other settings could be especially effective in helping children with ASD.

CBI programmes have been developed and implemented in many countries, including Thailand. However, their practicability is diminished by limited access to the internet and caregiver disengagement due to generic foreign-language content. Therefore, the TEI4A-ATC programme has been developed to address these gaps. First, all of the modules are in Thai and are culturally adapted with locally relevant examples and caregiver scripts, thus hopefully reducing the occurrence of disinterest that has been seen with imported CBIs. Second, every video lesson, visual schedule and progress-tracking worksheet can be downloaded for offline use to ensure continuity for families with intermittent internet connectivity. Finally, this programme was designed to integrate multidisciplinary elements such as behavioural therapy, language stimulation and therapist-guided physical-activity exercises based on input from specialists in paediatrics, psychology, statistics, computer programming and physical education. These domains have not been combined within a single platform in existing CBIs. We hypothesise that the TEI4A-ATC programme can improve the outcomes of children with ASD and the KAP of caregivers compared with standard treatment. Our intention is to ensure the provision of appropriate care for children with ASD and to provide valuable evidence for the development of other CBI programmes for ASD treatment in the future.

The strengths of the programme are the video-based content for providing appropriate care for ASD in young children, and that the procedure for each step of ASD care and treatment is clear and easy to understand. Moreover, we will compare the results of applying the programme, including the children’s outcomes and the KAP of the caregivers, before and after treatment. Next, we will evaluate the adherence of the caregivers to applying the programme, which will provide insight into the benefits or drawbacks of using it. However, there are some limitations to this study. First, recruitment for the sample used in this study was only conducted in the northern region of Thailand, so the generalisability of the findings to the rest of the Thai population may not be feasible due to the different cultural characteristics of the participants in other areas of the country. Second, the programme is registered and implemented using the Line application; some participants in rural areas may lack internet-accessible devices and thus will be unable to take part in this programme.

Trial status

This study was registered in the Thai Clinical Trials Registry (TCTR20240320010) on 20 March 2024. Recruitment will start on 19 June 2024 and anticipated to be completed for the last subject by 31 October 2024. The completion date (last visit) of the last subject is anticipated on 30 January 2025.

Ethics and dissemination

This study was approved by the Human Research Ethics Committee for Mental Health and Psychiatry, Department of Mental Health, Ministry of Public Health (DMH.IRB.COA 037/2565). The study protocol, the informed consent document and any subsequent modifications will be reviewed and approved by the ethics committee responsible for the oversight of the study. Written informed consent will be obtained from the legal guardians of the children prior to inclusion in the study. The informed consent document contains the purpose of the study, the procedures to be followed and the risks and benefits for the participant. The research data may be used in future research and may be published. A copy of the consent form will be given to the guardian. The study’s findings may be disseminated through scientific publications and conference presentations. The results of the study will be shared with key stakeholders, including caregivers, psychiatrists, policymakers and the general public, via appropriate dissemination channels to aid in creating appropriate practice and policy guidelines.

We would like to thank all of the individuals involved in the development of the TEI4A-ATC programme. We gratefully acknowledge the support for this study provided by the Rajanagarindra Institute of Child Development and the Nan, Phrae, Fang, Lamphun, Chomthong, Phayao, Chiangrai Prachanukroh, Lampang and Nakornping hospitals and Chiang Mai University.

Ethics statements

Patient consent for publication

Not applicable.

Footnote

Contributors All authors have been involved in conception of the study. DT is the principal investigator of the study and supervised the development of the study protocol, the process of patient recruitment and funding acquisition. SS, VT and SK contributed significantly to paper conceptualisation and the final editing of the paper. AS, SL, KP, KC and MP prepared the manuals for therapists and research assistants. PT, PS, ST and NS corresponded to the sample size estimation, statistical analysis of this proposal. PT organises and supervises the process of patient recruitment, project methodologist and supported the design and proposed analytical plan for the project. All authors have been involved in drafting the manuscript and have read and approved the final manuscript. DT is the guarantor who accepts full responsibility for the finished article, had access to any data and controlled the decision to publish.

Funding This study received funding from the Health Systems Research Institute (HSRI) (grant numbers 65-067 and 67-112). The funding source has no role in this manuscript.

Competing interests None declared.

Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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²⁵ Department of Mental Health, Ministry of Public Health. Thai early developmental assessment for intervention: TEDA4I. Sirithongthaworn S, Benjaponpithak A, Sriwongpanich N, eds. The Agricultural Cooperative Federation of Thailand, Ltd, 2015.

²⁶ Chow S-C, Shao J, Wang H, et al. Sample size calculations in clinical research. 3rd edn. New York: Chapman and Hall/CRC, 2017.