Clinical trial NCT06262646: Video-conferencing FACT for Young Children With Special Needs
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Hong Kong Christian Service
name: Hong Kong Federation of Youth Groups
name: Hong Kong Young Women's Christian Association
name: Yang Memorial Methodist Social Service
name: Hong Kong Sheng Kung Hui Welfare Council Limited
First posted: 2024-02-16
Enrollment: 253
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm Randomised Controlled Trial (RCT) with a repeated-measures parallel-group design
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Parenting stress
timeFrame: Change from baseline to immediate and 6 months post-intervention
Secondary outcomes:
measure: Parental depressive symptoms
timeFrame: Change from baseline to immediate and 6 months post-intervention
measure: Parental anxiety symptoms
timeFrame: Change from baseline to immediate and 6 months post-intervention
measure: Parental Psychological Flexibility
timeFrame: Change from baseline to immediate and 6 months post-intervention
measure: ACT Core Process Utilization
timeFrame: Change from baseline to immediate and 6 months post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: