Depressive SymptomsNCT03301831
Resourcefulness Intervention With Parents of Technology-Dependent Children
A study testing Resourcefulness Training in people with Depressive Symptoms and Multiple Chronic Conditions, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Symptoms, Multiple Chronic Conditions, Family Caregivers
- What is being tested?
- Resourcefulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2018to 9 Dec 2019
- 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
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-5065
About this study
Official title: 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.
Read the 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.
- Being tested
- Resourcefulness Training
- Keywords
- Parents, Technology-Dependent Child, Resourcefulness
- Medical subject headings
- Depression, Multiple Chronic Conditions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resourcefulness TrainingBehavioural
Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
| Study group | Role | What they receive |
|---|---|---|
| Resourcefulness Training Intervention | Experimental | 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. Receives: Behavioral: Resourcefulness Training |
| Attention Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Depressive Cognitions Scale
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.
Measured: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
Medical Outcomes Short Form Health Survey (SF-12) Physical Health
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.
Measured: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
Medical Outcomes Short Form Health Survey (SF-12) Mental Health
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.
Measured: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
Secondary outcomes (2)
Feetham Family Functioning Survey
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
Measured: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
Resourcefulness Scale
Subjective survey of participants' personal and social resourcefulness. Score range is 0-140, where a higher score indicates greater resourcefulness.
Measured: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start5 Feb 2018
- Primary completion9 Dec 2019
- Study completion9 Dec 2019
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.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm RCT with participants randomized to either the intervention or attention control group.
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Valerie Toly, University Hospitals Cleveland Medical Center
- Investigators
- Valerie A Toly, PhD, Principal investigator, Frances Payne Bolton School of Nursing, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301831
- Sponsor's protocol ID
- 08-10-30
- Other IDs
- 1R15NR017302-01
- Status last verified
- Sep 2021
- First submitted
- 24 Sep 2017
- Last updated
- 25 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study team is still conducting analysis and writing up study results for publication.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Pilot With Parents of Technology-Dependent Children
- ClinicalTrials.gov ID
- NCT03301831
- Acronym / sponsor ID
- 08-10-30
- Keywords
- Parents, Technology-Dependent Child, Resourcefulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 9 Dec 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Posted 25 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-arm RCT with participants randomized to either the intervention or attention control group.
| Arm | Type | Receives |
|---|---|---|
| Resourcefulness Training Intervention | Experimental | Behavioral: Resourcefulness TrainingThe 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. |
| Attention Control | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Resourcefulness TrainingCognitive-behavioral intervention that includes personal and social resourcefulness skills. | Behavioural | Resourcefulness Training Intervention |
Primary outcome
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.
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.
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.
2 secondary outcomes
Feetham Family Functioning Survey
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The study team is still conducting analysis and writing up study results for publication.
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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.
Valerie A Toly, PhD principal investigator
Frances Payne Bolton School of Nursing, Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resourcefulness Training in people with Depressive Symptoms and Multiple Chronic Conditions, run by University Hospitals Cleveland Medical Center 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 4 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 25 Oct 2021. 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 25 Oct 2021). 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?
Depressive Cognitions Scale (time frame: From baseline to 6 weeks, 3 months, and 6 months post-enrollment). 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?
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 25 Oct 2021.