- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02995408
Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder (ASD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karen Kuhlthau, PhD
- Phone Number: 617-724-2842
- Email: kkuhlthau1@PARTNERS.ORG
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
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: Experimental: 3RP treatment
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. Experimental arm participated in the 8-week 3RP program starting immediately after enrollment. |
|
Active Comparator: Waitlist control
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. The waitlist arm participated in the 8-week 3RP program starting 3 months after enrollment. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distress
Time Frame: change between baseline (week 0) to post intervention (week 12)
|
Visual Analogue Scale-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.
|
change between baseline (week 0) to post intervention (week 12)
|
Resiliency
Time Frame: change between baseline (week 0) to post intervention (week 12)
|
Current Experiences Scale is a 25-item measure of resilience adapted from the Post-Traumatic Growth Inventory to reflect current functioning in the domains of appreciation for life, adaptive perspectives, personal strength, spiritual connectedness, relating to others, and an additional four items to assess current adaptive health behaviors.
Total scores range from 0-25 and higher scores indicate greater resilience.
|
change between baseline (week 0) to post intervention (week 12)
|
Stress Reactivity/Coping
Time Frame: change between baseline (week 0) to post-intervention (week 12)
|
Measure of Current Status (MOCS-A) is a 13-item self-report measure developed to assess perceived status on ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses.
Total score range is 0 to 52, and higher scores indicate greater perceived proficiency with these skills.
|
change between baseline (week 0) to post-intervention (week 12)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress Reactivity
Time Frame: change between baseline (week 0) to post intervention (week 12)
|
Measure of current status validated self report questionnaire
|
change between baseline (week 0) to post intervention (week 12)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
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
- 2016P002037
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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