NCT07262853

Brief Summary

Executive function (EF) refers to the cognitive processes that enable goal-directed regulation of thoughts, emotions, and behaviours. Two interrelated domains are commonly distinguished: "cool" EF, which involves abstract cognitive processes, and "hot" EF, which involves regulation in emotionally or motivationally charged contexts. Children with special educational needs (SENs) frequently show difficulties across both domains, yet most interventions target one in isolation. The present study aims to evaluate the effectiveness of a dual EF training package for three of the most prevalent SENs groups: attention-deficit/hyperactivity disorder (ADHD), specific learning difficulties (SpLD), and autism spectrum disorder (ASD). A total of 288 primary school students aged 6-12 years with a diagnosis of ADHD, ASD, or SpLD will be recruited. Participants will be randomly assigned to either an intervention or waitlist control group, stratified by diagnosis. Each intervention group (n = 48) will receive the dual EF training programme, while corresponding waitlist controls (n = 48) will receive it after the study. Pre- and post-intervention assessments will include neuropsychological tests of EF, teacher- and parent-reported behavioural ratings, and measures of disability impact, school satisfaction, and social participation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Oct 2025Sep 2026

Study Start

First participant enrolled

October 13, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 23, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 4, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

November 23, 2025

Last Update Submit

November 23, 2025

Conditions

Keywords

Executive Functionsinterventionattention-deficit/hyperactivity disorderspecific learning difficultiesautism spectrum disorder

Outcome Measures

Primary Outcomes (14)

  • Verbal Working Memory

    Verbal working memory will be assessed using the backward digit spans subtest from the third edition of the Wechsler Intelligence Scale for Children-Third Edition (WISC-III).

    One week before the intervention

  • Verbal Working Memory

    Verbal working memory will be assessed using the backward digit spans subtest from the third edition of the Wechsler Intelligence Scale for Children-Third Edition (WISC-III).

    One week after the intervention

  • Inhibition

    The Stroop color and word test is a widely used assessment for measuring inhibition. In this test, participants will be presented with colour words printed in mismatched ink colors (for example, the word "red" written in blue ink). They will be instructed to quickly name the ink colour of each word while ignoring the word's meaning. This effort to suppress the meaning of the word to identify the ink colour consistently leads to longer response times compared to naming the colour of congruent stimuli (such as "red" printed in red ink).

    One week before the intervention

  • Inhibition

    The Stroop color and word test is a widely used assessment for measuring inhibition. In this test, participants will be presented with colour words printed in mismatched ink colors (for example, the word "red" written in blue ink). They will be instructed to quickly name the ink colour of each word while ignoring the word's meaning. This effort to suppress the meaning of the word to identify the ink colour consistently leads to longer response times compared to naming the colour of congruent stimuli (such as "red" printed in red ink).

    One week after the intervention

  • Attentional Control and Cognitive Flexibility

    The contingency naming test will assess attentional control and cognitive flexibility through four rules of increasing difficulty, using a stimulus set that includes nine practice items and 27 test items. Each stimulus will consist of an outer shape (circle, triangle, or square) in various colors (blue, yellow, or red), along with a smaller independent shape (circle, triangle, or square) inside the outer shape. Some stimuli will feature a backward arrow positioned directly above the outer shape. Participants will be instructed to name the stimuli based on the rule level within a set time limit.

    One week before the intervention

  • Attentional Control and Cognitive Flexibility

    The contingency naming test will assess attentional control and cognitive flexibility through four rules of increasing difficulty, using a stimulus set that includes nine practice items and 27 test items. Each stimulus will consist of an outer shape (circle, triangle, or square) in various colors (blue, yellow, or red), along with a smaller independent shape (circle, triangle, or square) inside the outer shape. Some stimuli will feature a backward arrow positioned directly above the outer shape. Participants will be instructed to name the stimuli based on the rule level within a set time limit.

    One week after the intervention

  • School Satisfaction

    School satisfaction will be assessed using six items derived from the Longitudinal Study of Australian Children. Respondents will rate each item on a four-point Likert scale ranging from strongly agree to strongly disagree.

    One week before the intervention

  • School Satisfaction

    School satisfaction will be assessed using six items derived from the Longitudinal Study of Australian Children. Respondents will rate each item on a four-point Likert scale ranging from strongly agree to strongly disagree.

    One week after the intervention

  • Executive Function

    A short form of the Behavior Rating Inventory of Executive Function (BRIEF) includes questionnaires for both parents and teachers aimed at evaluating EF in home and school settings. The BRIEF contains 24 items, which produce eight scales: Initiate, working memory, plan/organise, organisation of materials, monitor, inhibit, shift, and emotional control. Parents and teachers will rate their child or student's behaviour on a 3-point Likert scale, ranging from 1 (never) to 3 (often).

    One week before the intervention

  • Executive Function

    A short form of the Behavior Rating Inventory of Executive Function (BRIEF) includes questionnaires for both parents and teachers aimed at evaluating EF in home and school settings. The BRIEF contains 24 items, which produce eight scales: Initiate, working memory, plan/organise, organisation of materials, monitor, inhibit, shift, and emotional control. Parents and teachers will rate their child or student's behaviour on a 3-point Likert scale, ranging from 1 (never) to 3 (often).

    One week after the intervention

  • Social Participation

    The Social Participation Questionnaire consists of 24 statements distributed across four subscales: Friendships/relationships (five items), contacts/interactions (nine items), student's social self-perception (five items), and acceptance by classmates (five items). Class teachers will complete the SPQ for the students by responding to the statements on a 5-point Likert-type scale, with options ranging from 1 (this does not apply at all) to 5 (this strongly applies).

    One week before the intervention

  • Social Participation

    The Social Participation Questionnaire consists of 24 statements distributed across four subscales: Friendships/relationships (five items), contacts/interactions (nine items), student's social self-perception (five items), and acceptance by classmates (five items). Class teachers will complete the SPQ for the students by responding to the statements on a 5-point Likert-type scale, with options ranging from 1 (this does not apply at all) to 5 (this strongly applies).

    One week after the intervention

  • Severity of Disability

    The severity of disability will be measured based on the seven domains of life: material well-being, health, safety, productive activity, place in community, intimacy, and emotional well-being. The seven items will be rated on a 5-point Likert scale, ranging from 1 (not at all affected) to 5 (extremely affected).

    One week before the intervention

  • Severity of Disability

    The severity of disability will be measured based on the seven domains of life: material well-being, health, safety, productive activity, place in community, intimacy, and emotional well-being. The seven items will be rated on a 5-point Likert scale, ranging from 1 (not at all affected) to 5 (extremely affected).

    One week after the intervention

Study Arms (6)

Experimental: ADHD Group

EXPERIMENTAL

This experimental group will receive the executive function training in primary schools in Hong Kong.

Other: Executive Function Training

Experimental: RD Group

EXPERIMENTAL

This experimental group will receive the executive function training in primary schools in Hong Kong.

Other: Executive Function Training

Experimental: ASD Group

EXPERIMENTAL

This experimental group will receive the executive function training in primary schools in Hong Kong.

Other: Executive Function Training

Waitlist Control: ADHD Group

NO INTERVENTION

Students assigned to the waitlist control group will receive the executive function training program after the experimental group has completed it.

Waitlist Control: RD Group

NO INTERVENTION

Students assigned to the waitlist control group will receive the executive function training program after the experimental group has completed it.

Waitlist Control: ASD Group

NO INTERVENTION

Students assigned to the waitlist control group will receive the executive function training program after the experimental group has completed it.

Interventions

All students will participate in a structured EF training program designed to support those with SENs. The EF training program will include weekly group training sessions lasting one hour each, which will be organised in small groups of six students to foster interaction and peer support.

Experimental: ADHD GroupExperimental: ASD GroupExperimental: RD Group

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • aged between 6 and 11 years
  • studying at primary schools in HK
  • confirmed or suspected ADHD, ASD, or SpLD

You may not qualify if:

  • received executive function training
  • comorbid conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EdUHK

Tai Po, Hong Kong

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityDyslexiaAutistic DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSpecific Learning DisorderLearning DisabilitiesSigns and SymptomsPathological Conditions, Signs and SymptomsChild Development Disorders, Pervasive

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomised controlled trial will be adopted in which all assessors are blinded to the treatment condition of the students. Participants will be randomly assigned to either an experimental or a waitlist control group, stratified by diagnosis. Each intervention group (n = 48) will receive the dual EF training programme, while corresponding waitlist controls (n = 48) will receive it after the study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2025

First Posted

December 4, 2025

Study Start

October 13, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

December 4, 2025

Record last verified: 2025-11

Locations