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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06206070
Other study ID # EA230386
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date December 2025

Study information

Verified date December 2023
Source The University of Hong Kong
Contact Winnie Tam
Phone +852 3643 1770
Email winnie_toy@sahk1963.org.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The main questions it aims to answer are: - whether the Westmead Feelings Program 2 Hong Kong version (WFP2-HK) program is effective in improving children's social-emotional skills and mental well-being. - whether the WFP2-HK program is effective in promoting parents' mental well-being Child participants will receive 15 sessions of training in the WFP2-HK program. Their parents and teachers will receive three training workshops by coaches or advisors. A booster session will be conducted after 5 months upon completion of the training. Researchers will compare the outcome results between the treatment group and the waitlist group to see if the intervention is effective.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date December 2025
Est. primary completion date August 2025
Accepts healthy volunteers No
Gender All
Age group 8 Years to 14 Years
Eligibility Inclusion Criteria: - Diagnosed with Autism Spectrum Disorder - Without a diagnosis of Intellectual Delay - Have not received any group training in emotional regulation previously Exclusion Criteria: - Without ASD diagnosis - Age falls outside the age limits - With Intellectual Delays

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
The Hong Kong version of Westmead Feeling Program 2
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.

Locations

Country Name City State
Hong Kong University of Hong Kong Hong Kong

Sponsors (3)

Lead Sponsor Collaborator
The University of Hong Kong SAHK, Sydney Children's Hospitals Network

Country where clinical trial is conducted

Hong Kong, 

References & 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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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