- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03301831
Resourcefulness Intervention With Parents of Technology-Dependent Children
September 27, 2021 updated by: Valerie Toly, University Hospitals Cleveland Medical Center
Intervention Pilot With Parents of Technology-Dependent Children
Technology-dependent children, those who live at home but rely on medical equipment such as mechanical ventilation or feeding tubes, require complex care for their chronic condition.
Parents usually provide a majority of their care and are often overwhelmed by the caregiving demands resulting in deterioration of their own mental and physical health.
The goal of this 2-arm (intervention vs. attention control) RCT is to test a cognitive-behavioral Resourcefulness Training intervention that includes teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
The intervention is proposed to improve these caregivers' mental and physical health outcomes and family functioning outcomes while they continue to provide vital care for these vulnerable children.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Technology-dependent children, those who rely on medical equipment such as mechanical ventilation or feeding tubes for daily care at home, are among the sickest and most vulnerable subset of children with complex chronic conditions.
An estimated 600,000 children in the United States are technology dependent and live at home, and are cared for primarily by their parents.
These parents report greater levels of depressive symptoms and stress than other caregiver groups.
In addition, these caregivers report poor psychological and physical health that compromise their caregiving capacity and increase their use of emergency rooms (ER) for their children's care needs.
Despite these adverse consequences, there are no interventions to meet the needs of these caregivers and their children.
Resourcefulness Training, (cognitive-behavioral self-management intervention) has been shown to improve psychological and physical outcomes, mediate the effects of stress, and enhance the care provided to care-recipients.
It will be tested in a randomized trial against an attention-only control arm.
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
The aims of the study are to: 1) Determine whether Resourcefulness Training versus Attention Control improves psychological (general mental health, depressive cognitions, depressive symptoms, appraised stress, burden) and physical outcomes (general physical health, chronic stress [hair cortisol]) and family functioning over 6 months in parents of technology-dependent children, after controlling for the parents' race/ethnicity, sex, family income, and children's functional status; and 2) Determine whether changes in psychological and physical outcomes and family functioning are mediated by changes in parents' levels of resourcefulness (personal and social).
Data collection will take place at baseline then 6 weeks, 3 months, and 6 months post-enrollment.
Our study will be the first to test a resourcefulness intervention for this caregiver population and to include male as well as female caregivers.
This intervention is distinctive in that it uses web, telephone, and journal components for reinforcement-not multiple face-to-face visits that can be labor intensive.
If shown to be efficacious, it can be easily replicated with other populations with strong potential for translation into practice.
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106-5065
- University Hospitals Cleveland Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- parent caregiver (biological, adoptive, or foster mother, father, grandmother or grandfather) for a technology-dependent child based on the Office of Technology Assessment (OTA) classification criteria (Group 1, mechanical ventilator; Group 2, intravenous nutrition/medication; Group 3 respiratory or nutritional support)
- at least 18 years of age
- able to speak and understand English due to the availability of the intervention and instruments in English only
- the technology-dependent child must be age 17 years or younger and receive care in the home from his/her parent
Exclusion Criteria:
- Parents of children with a cancer diagnosis will be excluded from participation due to the potentially life-threatening, terminal nature of the illness and grief reactions associated with a cancer diagnosis that may limit their ability to participate over the 6 month study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resourcefulness Training Intervention
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
|
Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
|
No Intervention: Attention Control
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive Cognitions Scale
Time Frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Subjective measure of participant depressive cognitions- precursor of depressive symptoms.
Score range for the instrument is 0-40, where a higher score indicates greater depressive cognition.
|
From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Medical Outcomes Short Form Health Survey (SF-12) Physical Health
Time Frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment.
Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.
|
From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Medical Outcomes Short Form Health Survey (SF-12) Mental Health
Time Frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment.
Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.
|
From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feetham Family Functioning Survey
Time Frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Change in Family Functioning from Baseline to 6 Months Post Enrollment.
This subjective measure of family functioning is collected via participant survey.
The score range is 0-175, which is the sum of the "differences" between reality and life expectations.
Higher 'Difference' score indicates an imbalance between reality and life expectations
|
From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Resourcefulness Scale
Time Frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Subjective survey of participants' personal and social resourcefulness.
Score range is 0-140, where a higher score indicates greater resourcefulness.
|
From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Valerie A Toly, PhD, Frances Payne Bolton School of Nursing, Case Western Reserve University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2018
Primary Completion (Actual)
December 9, 2019
Study Completion (Actual)
December 9, 2019
Study Registration Dates
First Submitted
September 24, 2017
First Submitted That Met QC Criteria
September 28, 2017
First Posted (Actual)
October 4, 2017
Study Record Updates
Last Update Posted (Actual)
October 25, 2021
Last Update Submitted That Met QC Criteria
September 27, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-10-30
- 1R15NR017302-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The study team is still conducting analysis and writing up study results for publication.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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