Development of a Resiliency Training Program for Parents of Children With Specific Learning Disabilities (SPLD)
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ClinicalTrials.gov Identifier: NCT02772432 |
Recruitment Status :
Completed
First Posted : May 13, 2016
Results First Posted : September 10, 2019
Last Update Posted : September 10, 2019
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Tracking Information | ||||
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First Submitted Date ICMJE | May 12, 2016 | |||
First Posted Date ICMJE | May 13, 2016 | |||
Results First Submitted Date ICMJE | May 25, 2019 | |||
Results First Posted Date ICMJE | September 10, 2019 | |||
Last Update Posted Date | September 10, 2019 | |||
Actual Study Start Date ICMJE | September 1, 2016 | |||
Actual Primary Completion Date | May 18, 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Perceived stress [ Time Frame: change between baseline (week 0) to post intervention (week 52) ] perceived stress scale 10-item self report questionnaire
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
Stress Reactivity [ Time Frame: change between baseline (week 0) to 12 weeks post intervention ] The Measure of Current Status Part A (MOCS-A) is a 13-item self-report measure developed to assess participants' current self-perceived status on several skills: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed. Scores can range from 0 to 52, and higher scores are correlated with greater self- perceived proficiency with these skills.
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Original Secondary Outcome Measures ICMJE |
Stress Reactivity [ Time Frame: change between baseline (week 0) to post intervention (week 52) ] Measure of current status validated self report questionnaire
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Development of a Resiliency Training Program for Parents of Children With Specific Learning Disabilities | |||
Official Title ICMJE | Development of a Resiliency Training Program for Parents of Children With Specific Learning Disabilities | |||
Brief Summary | This study has three aims: Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and parents with children with special needs, this study aims to identify the psychosocial needs of parents of children with learning disabilities, specifically a) the types of concerns that parents find most difficult and stressful b) areas of concern that lack support and resources, and c) areas of need for education and skill training. This study also aims to gather feedback on the Benson-Henry Institute's Relaxation Response Resiliency Program (3RP). Phase II: Informed by Phase I findings, this study aims to develop and determine the feasibility and acceptability of a virtual 8-session Relaxation Response Resiliency (3RP) program for parents of children with Specific Learning Disabilities (SPLD). Phase II: This study also aims to test the effectiveness of a pilot wait-list control trial, establishing efficacy of a virtual resiliency program. |
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Detailed Description | According to the 2011/12 National Survey of Children's Health, 14.6 million children in the U.S. have special health care needs (e.g., learning disability, ADD/ADHD, developmental delays, chronic mental or physical health conditions); CSHCN comprise between 14.4%-25.6% of the child population in the United States. Having a child with special health care needs (CSHCN) is associated with an increased risk of problems with emotional and physical health and social well-being. Parents of CSHCN are also at an increased risk for not being employed, financial stress, and poor healthrelated quality of life (HRQoL). There is growing literature on the increased levels of parental stress associated with caring for CSHCN. One study found that chronic stress, as measured by the duration of having a CSHCN, was associated with an increase in clinical aging, determined by telomeres (caps at the end of each strand of DNA that protect chromosomes during aging) sequences. A review article provides a comprehensive overview of the links between high levels of parental stress among parents of children with intellectual and developmental disabilities and child health and well-being. Furthermore, a recent study documented that parents of SSHCN feel socially isolated. Therefore, having a child with special health care needs (CSHCN) is associated with an increased risk of problems with emotional and physical health and social well-being. Parents of CSHCN are also at an increased risk for not being employed, financial stress, and poor health-related quality of life (HRQoL). There is growing literature on the increased levels of parental stress associated with caring for CSHCN, and a recent review article provides a comprehensive overview of the links between high levels of parental stress among parents of children with intellectual and developmental disabilities and child health and well-being. Resiliency is a multidimensional construct that refers to the ability to maintain adaptation and effective functioning when faced with stressors. Resiliency provides a framework for understanding the adjustment to stress as a dynamic process. Allostasis refers to the capacity to maintain stability of physiological systems in the face of adversity. When the exposed to chronic stressors, such as care for a CSHCN, individuals expend a great deal of energy attempting to maintain allostasis; this can lead to the metabolic wear and tear described as allostatic load. Evidence is accumulating that this wear and tear is mediated by changes in basal stress system activity and by effects of these changes on dependent systems. Allostatic load and resilience can therefore be assessed by measuring basal stress system activity (HPA axis and salivary alpha-amylase). Thus, research to reduce these parents' exposure to stress and, moreover, improve parental responses to stress, may improve the well-being of both parents and their children. Yet, a treatment focused on the psychosocial needs of parents of CSHCN has not been developed. Thus, research is warranted to examine and intervene upon parental stress. Through focus group interviews with expert clinicians, leaders of organizations, and parents with children with special needs, this study aims to identify the psychosocial needs of parents of children with learning disabilities, specifically a) the types of concerns that parents find most difficult and stressful b) areas of concern that lack support and resources, and c) areas of need for education and skill training. This study also aims to gather feedback on the Benson-Henry Institute's Relaxation Response Resiliency Program (3RP) to advance our next objective to develop a resiliency intervention to provide support to parents of children with learning disabilities. This study aims to evaluate the virtual 3RP for Parents of SPLD in a wait-list control trial and determine a) its feasibility and acceptability and b) its effectiveness at decreasing stress and stress reactivity. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Patients are assigned to the immediate or wait-list control intervention group. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Stress | |||
Intervention ICMJE | Behavioral: Relaxation Response Resiliency Training for Parents of SPLD | |||
Study Arms ICMJE |
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Publications * | Park ER, Perez GK, Millstein RA, Luberto CM, Traeger L, Proszynski J, Chad-Friedman E, Kuhlthau KA. A Virtual Resiliency Intervention Promoting Resiliency for Parents of Children with Learning and Attentional Disabilities: A Randomized Pilot Trial. Matern Child Health J. 2020 Jan;24(1):39-53. doi: 10.1007/s10995-019-02815-3. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
53 | |||
Original Estimated Enrollment ICMJE |
35 | |||
Actual Study Completion Date ICMJE | May 18, 2018 | |||
Actual Primary Completion Date | May 18, 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Inclusion criteria for 3RP intervention:
Exclusion Criteria: Exclusion criteria for participation in 3RP group:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02772432 | |||
Other Study ID Numbers ICMJE | 2016P000423 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Responsible Party | Elyse Park, PhD, Massachusetts General Hospital | |||
Study Sponsor ICMJE | Massachusetts General Hospital | |||
Collaborators ICMJE | Marino Foundation | |||
Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | |||
Verification Date | September 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |