Development of a Resiliency Training Program for Parents of Children With Specific Learning Disabilities

NCT ID: NCT02772432

Last Updated: 2019-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2018-05-18

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.

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.

Conditions

Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Relaxation Response Resiliency Training for Parents of SPLD

Intervention Type: BEHAVIORAL

Waitlist control

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with specific learning disabilities.

Group Type: ACTIVE_COMPARATOR

Relaxation Response Resiliency Training for Parents of SPLD

Intervention Type: BEHAVIORAL

Interventions

Relaxation Response Resiliency Training for Parents of SPLD

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Being the parent of at least one elementary school aged child with a diagnosed specific learning disability

2. Age 18 or older

Exclusion Criteria

1. Being the parent of a child with a severe mental or physical disability up to the discretion of the principal investigator

2. Unable or unwilling to sign the informed consent documents

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Marino Foundation

UNKNOWN

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elyse Park, PhD

Associate Professor in Psychiatry (HMS)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elyse Park, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31650412 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016P000423

Identifier Type: -

Identifier Source: org_study_id