Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06262646
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2024-02-01
Brief Title:
Video-conferencing FACT for Young Children With Special Needs
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 haveare at high risk for having chronic physical developmental behavioural andor emotional conditions requiring specialized and considerable health and related services of typesamount 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 17193 in 2019 and an annual increase rate of 62-107 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 childs 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 parents capacity to respond to the demands of the childs illness which may in turn exacerbate the childs 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 eg 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 PIs 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 andor 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 192 ranging from 0-608 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 processes they need to work on first Given Hong Kongs 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 ones 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 070 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 PIs 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 studys 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
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 childs 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 parents capacity to respond to the demands of the childs illness which may in turn exacerbate the childs 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 eg 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 PIs 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 andor 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 192 ranging from 0-608 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 processes they need to work on first Given Hong Kongs 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 ones 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 070 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 PIs 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 studys 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None