Comparative Effectiveness of Family-Oriented Interventions vs. Subtain Academy Center Services on Enhancing Non-Verbal Skills in Children with ASD Aged 3-5 Years

This study aims to compare the effectiveness of two intervention methods—family-oriented intervention and services at the Subtain Academy Center —in enhancing the non-verbal skills of children aged 3-5 with ASD.

A randomized, single-blind, parallel-group controlled clinical trial on 60 patients

Families with non-verbal autistic children aged 3-5 years who visit Al-Sibtain Educational Center during the study period will be screened for eligibility. Qualified participants will be enrolled in the study and randomly assigned to either intervention or control groups using block randomization. The study will follow a single-blind design where assessors of non-verbal skills and data analysts will remain blinded to the intervention type.

Inclusion criteria: Families with a child between 3 and 5 years old who has received a clinical diagnosis of autism; the child exhibits impaired nonverbal communication skills; The child has no other documented medical or psychological conditions according to their medical records; The child has toilet problems based on parent report. Exclusion criteria: The child has a high level of verbal skills; Child's primary language is not Arabic; Lack of Parental Adherence to the Study Protocol.

The intervention group will receive a 47-session program over three months, integrating three core components: Pre-Linguistic Milieu Teaching, Video Self-Modeling, and a structured toilet-training protocol. The control group will receive 94 therapy sessions based on the Assessment of Basic Language and Learning Skills-Revised (ABLLS-R) curriculum, targeting language, social, and play skills.

pointing; vocal communication; eye gaze; functional play; and using the toilet independently

To ensure balanced group sizes and comparability across key prognostic factors, participants will be allocated to the study groups using a stratified block randomization method. An independent statistician, uninvolved in recruitment or intervention, will generate the allocation sequences. The randomization will be stratified by age and baseline non-verbal ability to ensure balance within these subgroups. For each resulting stratification cell, a computer-generated sequence will be created using a block size of 6, ensuring that within every block of 6 participants, 3 will be assigned to the intervention group and 3 to the control group. To guarantee strict allocation concealment, these sequences will be implemented and stored within a central, web-based randomization module (Medidata.com). Upon enrollment of an eligible participant, the site coordinator, blinded to the sequence, will enter the participant's stratification details into the system, which will then automatically reveal the ensuing group assignment.

This study will employ a single-blind (assessor-blind) design to minimize detection bias. Outcome assessors, responsible for coding video-based primary outcomes, and the data analyst will remain fully blinded to group allocation. To ensure the integrity of the blinding protocol, assessors will be trained specifically for this role and will have no contact with participants or other study staff. All video recordings of assessments will be edited by an independent research assistant to remove any auditory or visual cues (e.g., mentions of intervention-specific strategies, identifiable backgrounds) that could reveal group assignment. The assessors will analyze these blinded videos using a standardized coding protocol that is focused solely on observable behaviors. Furthermore, to test the integrity of the blinding procedure, assessors will be asked to guess the allocation of a random subset of participants upon study completion; a success rate approximating 50% will indicate effective blinding. In the event of accidental unblinding, the affected assessments will be re-allocated to another blinded coder. While participants and interventionists cannot be blinded due to the nature of the interventions, parents will be kept unaware of the study’s specific hypotheses to mitigate potential performance bias.

Only part of the data, such as information related to the main outcome or the like, can be shared.

Access period starts 6 months after results are published.

Our data will only be available to researchers working in academic and scientific institutions.

Researchers who submit the requested form (via email) including the following: purpose of analysis, required assessments, ethical review (if applicable), and data security plan. Data requests will be approved only for: secondary analyzes (e.g., meta-analyses, subgroup analyzes by age/severity), methodological research (e.g., validation of assessment tools), and teaching/demonstration (with proof of academic affiliation).

Primary Contact for Data Requests: Name: Zahra Soleymani Email: Soleymanislp@gmail.com Phone: 00982177533939 Mailing Address: Department of Speech therapy, School of Rehabilitation, corner of Safi Alishah St., Shemiran Intersection, Enghelab St., Tehran., Iran., Postal Code: 1148965111

To request data/documents, applicants should submit a formal request via email (Soleymanislp@gmail.com) including a completed Data Request Form, ethics approval (if applicable), and a research proposal. we will review the requests in 4–6 weeks, assessing scientific merit, feasibility, and privacy risks. If approved, applicants sign a Data Use Agreement (DUA) (1–2 weeks), after which data is shared via secure cloud links or encrypted email (1–7 days). The entire process typically takes 6–12 weeks, with post-access requirements like citations and progress reports.