ClinicalTrials.gg
CompletedNCT06262646Updated Jul 10, 2025

Video-conferencing FACT for Young Children With Special Needs

An interventional study of Focused Acceptance and Commitment Therapy and Control Group in Autism Spectrum Disorder, Attention Deficit Hyperactivity Disorder and Specific Learning Disorder, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-07-10.

Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
254
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study summary

Objective: This RCT evaluates the efficacy of Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing for parents of special needs children, targeting reducing parental stress (primary outcome), symptoms of depression and anxiety, as well as psychological flexibility.

Background: Parental caregiving for children with special needs is associated with significant stress, potentially impairing parental and familial functioning. Acceptance and Commitment Therapy (ACT) has shown promise in bolstering mental health across diverse populations. Preliminary findings from a feasibility trial (NCT05803252) suggest the potential of FACT in this context.

Methods: Expanding upon prior research, this definitive RCT compares FACT to standard parenting advice, correcting for earlier limitations through increased sample size and rigorous methodology. Assessments will be conducted at baseline, post-intervention (4-8 weeks), and 6-month follow-up.

Results: The study anticipates that FACT will demonstrate superior outcomes in promoting well-being among parents compared to parenting advice alone.

Conclusion: By leveraging videoconferencing for therapy delivery, the RCT aims to improve access to mental health interventions and emphasize the importance of psychological health among parents of special needs children. This could foster greater recognition and proactive management of mental health within this population.

Read the detailed description

INTRODUCTION Children with special health care needs (SHCN) are defined as those who have/are at high risk for having chronic physical, developmental, behavioural, and/or emotional conditions requiring specialized and considerable health and related services of type(s)/amount beyond 12 months. Although there is no central registry for children with SHCN in Hong Kong, for pre-schoolers with developmental conditions, there has been a prevailing rate of newly diagnosed cases of special health care needs children in Hong Kong (17,193 in 2019) and an annual increase rate of 6.2-10.7% in the number of referred cases for speciality follow-up services in the Child Assessment Centre under the Department of Health.

Parents of children with special health care needs (SHCN) have always been under tremendous pressure to take care of their children. They have been experiencing significant caregiving difficulties, such as scheduling and accompanying multiple follow-ups for rehabilitation and functional recovery and managing a child's symptoms and problematic behaviours. In addition, parenting stress has been known to affect parent-child interactions, increase negative parenting behaviours such as harsh, permissive, or neglectful parenting, and impair the parent's capacity to respond to the demands of the child's illness, which may, in turn, exacerbate the child's health problem and well-being. The above shows an emerging need to provide and expand mental health care support to these parents and children in a format that is sustainable and undisrupted by the restriction measures caused by the pandemic.

In literature, there has been increasing evidence supporting the efficacy of Acceptance and Commitment Therapy (ACT) on mental health in different population groups, including healthy individuals, parents, children, and those with mental health problems. Though the result was promising, the previous clinical trials in Hong Kong showed a limited effect size. This is due to the need for extensive manpower in ACT intervention, yet there are very limited trained ACT interventionists in Hong Kong. On top of that, past interventions have failed to target impaired psychopathological processes as well as identify and determine which psychopathological processes require intervention in the first place. This study aims to overcome the limitations mentioned above.

BACKGROUND Acceptance and Commitment Therapy Acceptance and Commitment Therapy (ACT) is a new form of mindfulness- and values-based behavioural therapy. In literature, ACT has demonstrated proven efficacy on the mental health symptoms of people diagnosed with depression and anxiety, as well as parents of children with developmental conditions (e.g., autism spectrum disorders and developmental delays).

The PI and her research team have conducted the first ACT clinical trial for Hong Kong parents of children with asthma, showing that a 4-session parental training programme using group-based ACT integrated with asthma education was more effective than education alone for improving parental psychological well-being, parental asthma management self-efficacy and childhood asthma morbidity. Currently, the PI's team is actively expanding the research studies in ACT to other population groups in Hong Kong, such as parents and their children with asthma comorbid with ADHD, parents of children with autism spectrum disorder, parents and their children with eczema and patients with early psychosis. In addition, our team has extensive experience in conducting clinical trials using mindfulness-based interventions for family caregivers and/or individuals with schizophrenia and dementia, as well as evaluating the efficacy of self-help programmes for facilitating patients with recent-onset psychosis to acquire better problem-solving abilities.

The results mentioned above encouraged the development of ACT in the service of parents in Hong Kong. Yet previous studies show that ACT could be a long-term intervention and require frequent follow-up, which would increase the burden on healthcare professionals. A recent systematic review of ACT for clients with anxiety and depression has highlighted the issues of multiple sessions (at least 6-8 weekly sessions for a completed treatment for one client) and notable attrition (with a mean of 19.2%, ranging from 0-60.8%). This could be attributed to the lack of targeting at parents' psychological needs by assessing how many psychopathological processes parents require for support and what process(es) they need to work on first. Given Hong Kong's development, there are exceptionally few trained ACT interventionists, and the time-consuming intervention would not be feasible.

The proposed study aims to overcome the above limitation by adopting Focused Acceptance and Commitment Therapy (FACT), which is a time-limited and brief intervention that provides systematic ACT intervention targeting parents' psychological needs and offering customized processed-matched ACT intervention.

Focused Acceptance and Commitment Therapy (FACT) FACT is a new model of brief therapy that is a highly condensed version of Acceptance and Commitment Therapy. As suggested by Strosahl, Robinson and Gustavsson, FACT aims to orient clients to observe and accept distressing experiences and unwanted emotions rather than attempting to suppress and control them, helping clients identify and connect with personal values and engaging in taking committed actions that are consistent with clients' own values through increasing one's psychological flexibility. In clinical trials, it was shown that brief ACT interventions were able to produce long-term results. A review of forty ACT components studies done by Levin, Hildebrant, Lillis \& Hayes showed an average weighted effect size of d= 0.70. The effect size of the brief intervention laid the way for the development of FACT. A study done by Strosahl, Hayes, Bergan, \& Romano revealed that a 4-session FACT intervention achieved the same clinical outcomes as a 4-session solution-focused brief therapy but had significantly fewer clients drop out of therapy and higher client satisfaction ratings. The PI's previous clinical trial using ACT for Hong Kong parents of children with asthma showed that a 4-session parental training programme using group-based ACT integrated with asthma education was more effective than education alone for improving parental psychological well-being, further proofing the efficacy of a focused and brief ACT intervention. Recently, a feasibility trial (104 participants) of FACT versus waitlist control showed the acceptability and feasibility and provided preliminary data for sample size estimation (see NCT05803252). The present definitive RCT evaluated the effectiveness of Focused ACT versus standard parenting advice.

STUDY AIMS AND HYPOTHESIS TO BE TESTED:

The study's aim is to determine the effectiveness of a video-conferencing Focused Acceptance and Commitment Therapy compared with standard parenting advice for parents of young children with special needs using a robust, randomized controlled trial design.

The hypothesis of the study is that Focused Acceptance and Commitment Therapy (FACT) delivered via videoconferencing will significantly improve parental stress (primary outcome), symptoms of depression, anxiety and psychological flexibility of parents in caring for their children with special needs at multiple intervals: immediately post-intervention, as well as at follow-up assessments six months later, compared to a control group receiving standard parenting advice.

02

Conditions studied

  • Autism Spectrum Disorder
  • Attention Deficit Hyperactivity Disorder
  • Specific Learning Disorder
  • Communication Disorders
  • Motor Disorders

Keywords

  • Acceptance and Commitment Therapy
  • Children with Special Needs
  • Parental psychological health
  • Parenting stress
  • Psychological Interventions
  • Randomized controlled trial
03

In context

Autism Spectrum Disorder

1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.

This study's enrollment of 254 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Language and Residency: Must be a Cantonese-speaking Hong Kong resident aged 21 years or older.
  • Child's age and health status: Must be cohabiting with a preschool or school-aged child (2-9 years old) diagnosed with or suspected of having special needs.
  • Caregiver role: Must be the primary caregiver responsible for daily care for the child.
  • Technology access: Must have daily access to a smartphone, with either an iPhone or Android operating system, to participate in the study and for potential app-based interventions or communications.

Exclusion criteria

Exclusion Criteria:

  • Any parents with severe mental illness, are pregnant, are less than six months postpartum, or have a developmental disability that interferes with their ability to comprehend the programme's content.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
254 participants (actual)

Study arms

  • Experimental
    FACT Group

    Parents will receive 4-6 FACT consultation sessions, one weekly session, 45-60 mins per session. These sessions will be one-on-one, conducted face-to-face or via video conferencing.

    Behavioral: Focused Acceptance and Commitment Therapy

  • Active comparator
    Control Group

    Parents will receive standard parenting advice about positive parenting tips recommended by the Child Assessment Services under the Department of Health.

    Other: Control Group

Interventions

  • BehavioralFocused Acceptance and Commitment Therapy

    Trained FACT interventionists will be guided by manualized FACT intervention to identify how many psychopathological processes need support and which ACT process(es) need to work on first, then offer parents process-matched ACT intervention strategies following the principles of FACT. The intervention strategies include ACT metaphors, experiential exercises, audio-guided mindfulness exercises, guided imagery exercises and value clarification exercises. The FACT steps in each session depend on the client's situation/stage.

    Also known as: FACT

  • OtherControl Group

    Both study groups will receive standard family support from collaborating NGOs.

06

What researchers measure

Primary outcomes

  1. Parenting stress

    The Parental Stress Scale (PSS, 18-item, 5-point scale) will be used to assess parenting stress. A higher score represents a higher level of parental stress. The Chinese version of the PSS has demonstrated acceptable psychometric properties and is therefore suitable for use by researchers to assess the parental stress levels of Chinese parents.

    Time frame: Change from baseline to immediate and 6 months post-intervention

Secondary outcomes

  1. Parental depressive symptoms

    The Patient Health Questionnaire (PHQ-9, 9-item, 4-point Likert scale) will be used to assess the frequency of the parents experiencing depressive symptoms in the past two weeks. The Chinese version of the PHQ-9 has demonstrated good internal consistency reliability (Cronbach's alpha = 0.86) and test-retest correlation coefficient (Cronbach's alpha = 0.86).

    Time frame: Change from baseline to immediate and 6 months post-intervention

  2. Parental anxiety symptoms

    The Generalized Anxiety Disorder-7 (GAD-7, 7-item, 4-point Likert scale) will be used to measure the severity of anxiety symptoms. The Chinese version of the GAD-7 demonstrated good reliability and validity with a Cronbach's coefficient of 0.91.

    Time frame: Change from baseline to immediate and 6 months post-intervention

  3. Parental Psychological Flexibility

    The PsyFlex is a 5-point Likert scale with six items to measure the six core processes of Acceptance and Commitment Therapy (ACT): staying present, cognitive defusion, acceptance, self-as-context, values, and committed action. This instrument provides a contextually sensitive measure of psychological flexibility.

    Time frame: Change from baseline to immediate and 6 months post-intervention

  4. ACT Core Process Utilization

    The CompACT-10 is a 10-item, 7-point Likert scale that assesses the critical processes of ACT. This tool has a three-factor structure with internal solid consistency and established convergent and divergent validity with existing measures of ACT processes, as well as indicators of social desirability, psychological distress, and general health and well-being.

    Time frame: Change from baseline to immediate and 6 months post-intervention

07

Study locations

1 site
  • The Chinese University of Hong Kong
    Hong Kong, Hong Kong
08

References and documents

Publications

  • Chong YY, Chan JKF, Yau PT, Li TMH, Fung KP, Chien WT. Videoconferencing acceptance and commitment therapy for parents of children with special health care needs: A randomised controlled trial. Int J Nurs Stud. 2026 Jul;179:105525. doi: 10.1016/j.ijnurstu.2026.105525. Epub 2026 Apr 14. PubMed 41985265 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2024 to primary completion in Jan 2025, 11 months.

Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 11 months is below that.

Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2024
First posted
Feb 16, 2024
StartActual
Feb 1, 2024
Primary completionActual
Jan 31, 2025
CompletionActual
Jun 30, 2025
Last update
Jul 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06262646
Collaborators
Hong Kong Christian Service, Hong Kong Federation of Youth Groups, Hong Kong Young Women's Christian Association, Yang Memorial Methodist Social Service, Hong Kong Sheng Kung Hui Welfare Council Limited
Responsible party
Yuen Yu CHONG (Assistant Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Feb 16, 2024
Start date
Feb 1, 2024
Primary completion
Jan 31, 2025
Completion
Jun 30, 2025
Last update
Jul 10, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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