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Autism Spectrum DisorderNCT06262646

Video-conferencing FACT for Young Children With Special Needs

A study testing Focused Acceptance and Commitment Therapy in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Focused Acceptance and Commitment Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
254 participants
Where
1 siteHong Kong
Study dates
1 Feb 2024to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site
  • The Chinese University of Hong Kong

    Hong Kong

Other trials in Hong Kong

About this study

Official title: Effectiveness of Video-conferencing Focused Acceptance and Commitment Therapy Compared With Standard Parenting Advice for Parents of Young Children With Special Needs: A Randomized Clinical Trial

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.

Read more

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.

Being tested
Focused Acceptance and Commitment Therapy, Control Group
Keywords
Acceptance and Commitment Therapy, Children with Special Needs, Parental psychological health, Parenting stress, Psychological Interventions, Randomized controlled trial
Medical subject headings
Autism Spectrum Disorder, Attention Deficit Disorder with Hyperactivity, Specific Learning Disorder, Communication Disorders, Motor Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Focused Acceptance and Commitment TherapyBehavioural

    Also called FACT

    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.

  • Control GroupOther

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

Study groups in NCT06262646
Study groupRoleWhat they receive
FACT GroupExperimentalParents 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.
Receives: Behavioral: Focused Acceptance and Commitment Therapy
Control GroupActive comparatorParents will receive standard parenting advice about positive parenting tips recommended by the Child Assessment Services under the Department of Health.
Receives: Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (4)
  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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2024
  2. Study start1 Feb 2024
  3. Primary completion31 Jan 2025
  4. Study completion30 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
254 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06262646
Sponsor's protocol ID
NTEC-2023-677
Status last verified
Jul 2025
First submitted
1 Feb 2024
Last updated
10 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Focused Acceptance and Commitment Therapy in people with Autism Spectrum Disorder and Attention Deficit Hyperactivity Disorder, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parenting stress (time frame: Change from baseline to immediate and 6 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06262646, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.

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