StressASDNCT02995408
Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder
A study testing Relaxation Response Resiliency Program for Parents of Children with ASD in people with Stress, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Relaxation Response Resiliency Program for Parents of Children with ASD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being the parent of at least one child with a diagnosed autism spectrum disorder
- Age 18 or older
Who cannot join
- 1. Unable or unwilling to sign the informed consent documents
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
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).
Read more
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.
Read the 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.
- Conditions
- Stress
- Being tested
- Relaxation Response Resiliency Program for Parents of Children with ASD
- Keywords
- resiliency training, parenting, Autism Spectrum Disorders
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation Response Resiliency Program for Parents of Children with ASDBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Experimental: 3RP treatment | Experimental | 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. Receives: Behavioral: Relaxation Response Resiliency Program for Parents of Children with ASD |
| Waitlist control | Active comparator | 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. Receives: Behavioral: Relaxation Response Resiliency Program for Parents of Children with ASD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress
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.
Measured: change between baseline (week 0) to post intervention (week 12)
Resiliency
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.
Measured: change between baseline (week 0) to post intervention (week 12)
Stress Reactivity/Coping
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.
Measured: change between baseline (week 0) to post-intervention (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Kuhlthau, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995408
- Sponsor's protocol ID
- 2016P002037
- Acronym
- ASD
- Status last verified
- Mar 2024
- First submitted
- 14 Dec 2016
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kuhlthau KA, Luberto CM, Traeger L, Millstein RA, Perez GK, Lindly OJ, Chad-Friedman E, Proszynski J, Park ER. A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial. J Autism Dev Disord. 2020 Jul;50(7):2513-2526. doi: 10.1007/s10803-019-03976-4.
PubMed 30900195
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Resiliency Training Program for Parents of Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT02995408
- Acronym / sponsor ID
- ASD / 2016P002037
- Conditions
- Stress
- Keywords
- resiliency training, parenting, Autism Spectrum Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 16 Dec 2016 (estimated)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: 3RP treatment | Experimental | Behavioral: Relaxation Response Resiliency Program for Parents of Children with ASDAn 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. |
| Waitlist control | Active comparator | Behavioral: Relaxation Response Resiliency Program for Parents of Children with ASDAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being the parent of at least one child with a diagnosed autism spectrum disorder
- Age 18 or older
Key exclusion criteria (1 listed)
- 1. Unable or unwilling to sign the informed consent documents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation Response Resiliency Program for Parents of Children with ASD | Behavioural | Experimental: 3RP treatment, Waitlist control |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30900195Kuhlthau KA, Luberto CM, Traeger L, Millstein RA, Perez GK, Lindly OJ, Chad-Friedman E, Proszynski J, Park ER. A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial. J Autism Dev Disord. 2020 Jul;50(7):2513-2526. doi: 10.1007/s10803-019-03976-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Response Resiliency Program for Parents of Children with ASD in people with Stress, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distress (time frame: change between baseline (week 0) to post intervention (week 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02995408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.