An interventional study of Focused Acceptance and Commitment Therapy in Neurodevelopmental Disorders, Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder, sponsored by Chinese University of Hong Kong. Recruiting at 5 sites in Hong Kong. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
This study aims to determine the feasibility, acceptability and potential efficacy of an individual, video-conferencing based Focused Acceptance and Commitment Therapy (FACT) on the mental well-being of parents of children with Special Health Care Needs(SHCN). The study also aims to explore the experience of parents after participating in the individual-based FACT sessions offered by the trained FACT interventionists.
Parents of children with Special Health Care Needs (SHCN) have always been under tremendous pressure to care for their children. They have been experiencing significant caregiving difficulties, such as scheduling and accompanying multiple follow-ups for rehabilitation and functional recovery and managing the child's symptoms and problematic behaviours. With the strike of COVID-19, these parents' stress may even be exacerbated due to the lockdown measures. Children's needs become more demanding with the suspension of the usual care services. Parenting stress has been known to affect parent-child interactions and increase negative parenting behaviours such as harsh, permissive or neglecting parenting impairing 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. Recent evidence has advocated 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. To increase the reach of ACT and overcome the plausible disruptions of mental health services arising from the pandemic, the study proposes to use an innovative intervention approach, that is a brief version of ACT (Focused ACT), delivered by trained FACT interventionists in individual-based, video-conferencing format. The conversation data between the parent and the interventionist will be further analyzed for developing a Deep-Learning Mental Health Advisory System in the second phase of the Pai.ACT project. This study aims to determine the feasibility, acceptability and potential efficacy of an individual, video-conferencing-based Focused Acceptance and Commitment Therapy (FACT) on the mental well-being of parents of children with Special Health Care Needs(SHCN). The study also aims to explore the experience of parents after participating in the individual-based FACT sessions offered by the trained FACT interventionists.
352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.
This study's planned enrollment of 150 is above the median of 88 across 217 interventional studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →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.
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In addition, potential eligible parents who respond "yes" to any of the five validated screening questions in the Children with Special Health Care Needs (SHCN) Screener (see https://www.childhealthdata.org/docs/cshcn/technical-summary-of-cshcn-screener.pdf) will then be asked the associated follow-up questions to determine whether the child possesses physical, neurodevelopmental/emotional problem(s) that has lasted for at least 12 months. Only children with a positive response(s) to ≥ 1 item in each of the associated follow-up questions will be classified as children with SHCN.
Exclusion Criteria:
4-6 weeks of 45-60 minute individual-based Focused Acceptance and Commitment Therapy (FACT) counselling sessions delivered via video-conferencing format or face-to-face
Behavioral: Focused Acceptance and Commitment Therapy
This is an individual-based FACT counselling programme which composes of 4-6 sessions on a weekly basis (45-60mins/session). All the sessions are delivered by a trained FACT interventionist via either video-conferencing (e.g., Zoom or Windows Teams) or face-to-face format. The programme aims to increase the psychological flexibility of the parent, so that he/she is able to (i) experience the present moment and take perspective on self (i.e., Awareness); (ii) detach the distressing private experiences and associated rules and to take a non-judgemental, accepting stance toward the painful experiences (i.e., Openness) and (iii) exhibits strong connection with values and commit to values-consistent actions. The trained interventionist will use different ACT strategies in these sessions, including ACT metaphors, experiential exercises, guided mindfulness exercises, guided imagery exercises and values clarification exercises to reinforce the above principles.
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 a 2-week test-retest correlation coefficient.
Time frame: Change from baseline assessment to immediate post-assessment
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 assessment to immediate post-assessment
Parental Stress
The Parental Stress Scale (PSS, 16-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 assessment to immediate post-assessment
Parental Psychological Flexibility
The PsyFlex (6-item 5-point Likert Scale) will assess all the six therapeutic processes of Acceptance and Commitment Therapy (ACT). Each item refers to one of the core skills that ACT focuses on when developing psychological flexibility and well-being. The score is then interpreted such that higher scores represent higher psychological flexibility.
Time frame: Change from baseline assessment to immediate post-assessment
Started Dec 2022 (actual). Primary completion is estimated for Dec 2025, 36 months after the start.
Of 142 non-industry interventional studies with no phase under Neurodevelopmental Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 36 months is above that.
Counting every sponsor, half of 148 studies reached it within 30 months; a quarter within 15 and three quarters within 52.
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