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Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder (ASD)

Primary Purpose

Stress

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation Response Resiliency Program for Parents of Children with ASD
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring resiliency training, parenting, Autism Spectrum Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Being the parent of at least one child with a diagnosed autism spectrum disorder
  2. Age 18 or older

Exclusion Criteria:

1. Unable or unwilling to sign the informed consent documents

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental: 3RP treatment

Waitlist control

Arm Description

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

Outcomes

Primary Outcome Measures

Distress Tolerance
Distress Tolerance Scale, Visual Analogue Scale

Secondary Outcome Measures

Stress Reactivity
Measure of current status validated self report questionnaire

Full Information

First Posted
December 14, 2016
Last Updated
September 19, 2017
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02995408
Brief Title
Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder
Acronym
ASD
Official Title
Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study has three aims: Phase I: Through focus group interviews with expert clinicians, leaders of organizations, and parents with children with ASD, this study aims to identify the psychosocial needs of parents of children with ASD, 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 ASD. 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 Center for Disease Control in 2012, 14.6 per 1,000 children aged 8 years old have a diagnosis of Autism Spectrum Disorder (ASD). Having a child with ASD is associated with medical expenditures of 4.1-4.6 times more than having a child without autism, and associated with 8.4-9.5 times greater general expenditures. Furthermore, children with ASD are more likely to use out-of-school behavioral health services than children without developmental or psychiatric diagnoses. Parents of children with ASD consistently show high levels of perceived distress and anxiety related to child-parent relationships, intellectual functioning, adaptive behaviors, in addition to poorer health than parents of children of typical development. These parents also exhibit significant stress related to the emotional and financial challenges of putting together treatment and future-related plans for their children. Recent studies have found a positive relationship between caregivers' stress levels while raising a child with ASD and child behavioral and conduct problems. There is growing literature on the increased levels of parental stress associated with caring for children with ASD. One study found that caregivers of children with ASD with behavioral, hyperactivity, and emotional problems displayed atypical cortisol patterns, a biological marker of increased stress. 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. In addition to social phobias associated with children with ASD, one study even found that caring for a child with ASD showed higher stress levels for the parents correlated with the child's social impairment severity. Finally, recent studies have also found that many parents of children with ASD exhibit psychological and physical depressive symptoms. Therefore, having a children with ASD is associated with an increased risk of problems with emotional and physical health and social 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 exposed to chronic stressors, such as care for a child with ASD, 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 wellbeing of both parents and their children. Yet, a treatment focused on the psychosocial needs in relation to stress and allostatic load of parents of children with ASD has not been developed. Research is warranted to examine and intervene upon parental stress. This study aims to design and develop a resiliency intervention to provide support to parents of children with ASD. This intervention will be a modified version of Dr. Park's evidence-based 8-week multimodal treatment which is designed to promote adaptation to stress and promotion of resiliency. The program is an 8 session, 1-1.5 hours a week multi modal intervention that incorporates relaxation techniques, stress awareness discussion, and adaptive strategies for coping with stress. This study will refine an 8-session group virtual-delivered resiliency treatment program consisting of 8 virtual group 1-1.5 hour sessions. The goal of this study would be to advance our ultimate objective to implement a national parental resiliency program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress
Keywords
resiliency training, parenting, Autism Spectrum Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: 3RP treatment
Arm Type
Experimental
Arm Description
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Arm Title
Waitlist control
Arm Type
Active Comparator
Arm Description
An adapted version of the Relaxation Response Resiliency Program (3RP) for parents of children with ASD. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Response Resiliency Program for Parents of Children with ASD
Primary Outcome Measure Information:
Title
Distress Tolerance
Description
Distress Tolerance Scale, Visual Analogue Scale
Time Frame
change between baseline (week 0) to post intervention (week 12)]
Secondary Outcome Measure Information:
Title
Stress Reactivity
Description
Measure of current status validated self report questionnaire
Time Frame
change between baseline (week 0) to post intervention (week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being the parent of at least one child with a diagnosed autism spectrum disorder Age 18 or older Exclusion Criteria: 1. Unable or unwilling to sign the informed consent documents
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Kuhlthau, PhD
Phone
617-724-2842
Email
kkuhlthau1@partners.org
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Kuhlthau, PhD
Phone
617-724-2842
Email
kkuhlthau1@PARTNERS.ORG
First Name & Middle Initial & Last Name & Degree
Karen Kuhlthau, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder

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