- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02772432
Development of a Resiliency Training Program for Parents of Children With Specific Learning Disabilities (SPLD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02141
- Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Inclusion criteria for 3RP intervention:
- Being the parent of at least one elementary school aged child with a diagnosed specific learning disability
- Age 18 or older
Exclusion Criteria:
Exclusion criteria for participation in 3RP group:
- Being the parent of a child with a severe mental or physical disability up to the discretion of the principal investigator
- Unable or unwilling to sign the informed consent documents
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 3RP treatment
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.
The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
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Active Comparator: Waitlist control
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distress
Time Frame: change between baseline (week 0) to 12 weeks post intervention
|
The Visual Analog Scale (VAS)-Distress is a 1-item scale which asks responders to rate their level of distress on a scale of 0 to 10.
A higher score indicates more distress.
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change between baseline (week 0) to 12 weeks post intervention
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Current Experiences Scale
Time Frame: Change between baseline and 12-weeks
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The CES is a 25-item measure of resilience adapted from the Post-Traumatic Growth Inventory (PTGI) to reflect current functioning in the domains of appreciation for life (AL), adaptive perspectives (AP), personal strength (PS), spiritual connectedness (SC), relating to others (RO), and an additional four items to assess current adaptive health behaviors (HB) that are not part of the PTGI.
The CES is scored on a scale from 0-125 with higher scores indicating greater resilience.
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Change between baseline and 12-weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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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change between baseline (week 0) to 12 weeks post intervention
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Elyse Park, PhD, MPH, Massachusetts General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016P000423
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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