NCT06206070

Brief Summary

The goal of this intervention is to evaluate the effectiveness of delivering the Westmead Feelings Program 2 to children with Autism Spectrum Disorder in primary schools in Hong Kong.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 4, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 4, 2024

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

January 4, 2024

Last Update Submit

April 2, 2024

Conditions

Keywords

primary schoolsocial emotional competence

Outcome Measures

Primary Outcomes (10)

  • The Emotions Development Questionnaire - Parent Version (Hong Kong version)

    The Emotions Development Questionnaire measures the emotional competence in children with ASD at home and school, covering 5 subdomains, namely emotional understanding, empathy/theory of mind, emotional problem solving, emotional regulation, and emotion coaching skills. The scale consists of 29 items. Responses will be circled on a 5 point Likert scale, with 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Always, 0 = Don't know. The minimum value of the scale is 0, and the maximum value is 145. Higher scores indicate better emotional competence.

    Before the intervention

  • The Emotions Development Questionnaire - Parent Version (Hong Kong version)

    The Emotions Development Questionnaire measures the emotional competence in children with ASD at home and school, covering 5 subdomains, namely emotional understanding, empathy/theory of mind, emotional problem solving, emotional regulation, and emotion coaching skills. The scale consists of 29 items. Responses will be circled on a 5 point Likert scale, with 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Always, 0 = Don't know. The minimum value of the scale is 0, and the maximum value is 145. Higher scores indicate better emotional competence.

    18 weeks, immediately after the intervention

  • Emotion Development Questionnaire - Teacher Version (Hong Kong version)

    The Emotions Development Questionnaire measures the emotional competence in children with ASD at home and school, covering 5 subdomains, namely emotional understanding, empathy/theory of mind, emotional problem solving, emotional regulation, and emotion coaching skills. The scale consists of 29 items. Responses will be circled on a 5 point Likert scale, with 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Always, 0 = Don't know. The minimum value of the scale is 0, and the maximum value is 145. Higher scores indicate better emotional competence.

    Before the intervention

  • Emotion Development Questionnaire - Teacher Version (Hong Kong version)

    The Emotions Development Questionnaire measures the emotional competence in children with ASD at home and school, covering 5 subdomains, namely emotional understanding, empathy/theory of mind, emotional problem solving, emotional regulation, and emotion coaching skills. The scale consists of 29 items. Responses will be circled on a 5 point Likert scale, with 1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often, 5 = Always, 0 = Don't know. The minimum value of the scale is 0, and the maximum value is 145. Higher scores indicate better emotional competence.

    18 weeks, immediately after the intervention

  • Social Responsiveness Scale - 2 (SRS-2)

    The SRS-2 identifies social impairment associated with autism spectrum disorders \& distinguishes ASD from other disorders. It consists of 65 items. The questionnaire comprises five subscales: social awareness, social cognition, social communication, social motivation, restricted interests, and repetitive behavior. Items are scored on a four-point Likert-type scale, ranging from 1 = not true, 2 = sometimes true, 3 = often true, to 4 = almost always true. The minimum value of the scale is 65, and the maximum value is 260. Higher scores indicate more prominent ASD symptoms.

    Before the intervention

  • Social Responsiveness Scale - 2 (SRS-2)

    The SRS-2 identifies social impairment associated with autism spectrum disorders \& distinguishes ASD from other disorders. It consists of 65 items. The questionnaire comprises five subscales: social awareness, social cognition, social communication, social motivation, restricted interests, and repetitive behavior. Items are scored on a four-point Likert-type scale, ranging from 1 = not true, 2 = sometimes true, 3 = often true, to 4 = almost always true. The minimum value of the scale is 65, and the maximum value is 260. Higher scores indicate more prominent ASD symptoms.

    18 weeks, immediately after the intervention

  • The Learning, Social and Emotional Adaptation Questionnaire Short-Form (Primary) (LSEAQ-S(P))

    The LSEAQ-S(P) is a teacher report instrument measuring 53 essential adaptive behaviors for mainstream primary school students with ASD in Hong Kong. This questionnaire describes expected behaviors in school across three domains, namely, learning, social, and emotional adaptation, and an additional domain of restricted interests and repetitive behavior frequently observed in students with ASD. The questionnaire adopts four-point Likert scales for teachers to rate the frequency of the stated behavior observed in the previous month: 0 = the student never showed this behavior, 1 = the student showed this behavior less than half of the time,2= the student showed this behavior more than half of the time,3= the student nearly always showed this behavior. The restricted interests and repetitive behavior ratings were reverse-scored prior to analysis so that higher ratings indicated better adjustment in all domains. The minimum score for the scale is 0 and the maximum is 159.

    Before the intervention

  • The Learning, Social and Emotional Adaptation Questionnaire Short-Form (Primary) (LSEAQ-S(P))

    The LSEAQ-S(P) is a teacher report instrument measuring 53 essential adaptive behaviors for mainstream primary school students with ASD in Hong Kong. This questionnaire describes expected behaviors in school across three domains, namely, learning, social, and emotional adaptation, and an additional domain of restricted interests and repetitive behavior frequently observed in students with ASD. The questionnaire adopts four-point Likert scales for teachers to rate the frequency of the stated behavior observed in the previous month: 0 = the student never showed this behavior, 1 = the student showed this behavior less than half of the time,2= the student showed this behavior more than half of the time,3= the student nearly always showed this behavior. The restricted interests and repetitive behavior ratings were reverse-scored prior to analysis so that higher ratings indicated better adjustment in all domains. The minimum score for the scale is 0 and the maximum is 159.

    18 weeks, immediately after the intervention

  • Parenting Stress Index 4-Short Form

    The Short Form features 36 items drawn from the full-length form divided into three domains (Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child).Self-reported responses will be scored on a 5-point Likert scale ranging from "1" (Strongly agree) to "5" (Strongly disagree). Subscale scores are calculated by summing the scores of relevant items. A total stress score is obtained by combining the three subscale scores. A higher score denoted higher level of parenting stress. The minimum total score for this scale is 36 and the maximum is 180.

    Before the intervention

  • Parenting Stress Index 4-Short Form

    The Short Form features 36 items drawn from the full-length form divided into three domains (Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child).Self-reported responses will be scored on a 5-point Likert scale ranging from "1" (Strongly agree) to "5" (Strongly disagree). Subscale scores are calculated by summing the scores of relevant items. A total stress score is obtained by combining the three subscale scores. A higher score denoted higher level of parenting stress. The minimum total score for this scale is 36 and the maximum is 180.

    18 weeks, immediately after the intervention

Study Arms (2)

The Hong Kong version of Westmead Feeling Program 2

EXPERIMENTAL

The treatment group will receive the WFP2-HK program which consists of 15 school-based training sessions over 18 weeks. Three parent- and teacher-training workshops will be delivered separately and preceding each Child Module by coaches or advisors. A booster session will be conducted for the treatment group after 5 months upon completion of the training programs.

Behavioral: The Hong Kong version of Westmead Feeling Program 2

Waitlist Group

NO INTERVENTION

While the treatment group is receiving training, the waitlist group will be waiting. After 18 weeks of waiting and when the treatment group completes the training. The waitlist group will receive the same training program as that of the treatment group, but no booster session will be provided to the waitlist group.

Interventions

Westmead Feelings Program (WFP) is a manualized emotion-based learning intervention for children on the autism spectrum. WFP teaches autistic children how to understand their own and other's emotions, solve problems, and regulate emotions through the implementation of transactional support. In doing so, parents and teachers are also trained to develop their emotional coaching skills to support children in everyday settings. Its impact on improving emotional competence in primary school-aged children on the autism spectrum has been established in 41 mainstream schools in Australia.

Also known as: WFP2-HK
The Hong Kong version of Westmead Feeling Program 2

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed with Autism Spectrum Disorder
  • Without a diagnosis of Intellectual Delay
  • Have not received any group training in emotional regulation previously

You may not qualify if:

  • Without ASD diagnosis
  • Age falls outside the age limits
  • With Intellectual Delays

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

  • Wong, M., Lopes, A., Heriot, S., Brice, L., Carroll, L., Ratcliffe, B., & Dossetor, D. (2018). Westmead Feeling Program 2: Emotion-based Learning for Children with Autism Spectrum Disorder without Accompanying Intellectual Impairment. Camberwell, VIC: ACER Press. Ratcliffe, B., Wong, M., Dossetor, D., & Hayes, S. (2014). Teaching social-emotional skills to school-aged children with Autism Spectrum Disorder: A treatment versus control trial in 41 mainstream schools. Research in Autism Spectrum Disorders, 8(12), 1722-1733. doi:10.1016/j.rasd.2014.09.010

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants are assigned to treatment group and waitlist group in parallel for the duration of the study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2024

First Posted

January 16, 2024

Study Start

February 1, 2024

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

April 4, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations