N/A
N=93
Resourcefulness Intervention With Parents of Technology-Dependent Children
Depressive Symptoms · Multiple Chronic Conditions · Family Caregivers
Bottom Line
View on ClinicalTrials.gov: NCT03301831 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Depressive Cognitions Scale — 6.46; 6.97; 6.32; 7.28 Score on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Resourcefulness Training (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depressive Cognitions Scale |
6.46; 6.97; 6.32; 7.28; 5.65; 7.93 | — |
| PRIMARY Medical Outcomes Short Form Health Survey (SF-12) Physical Health |
52.7; 50.77; 54.49; 49.46; 51.49; 49.81 | — |
| PRIMARY Medical Outcomes Short Form Health Survey (SF-12) Mental Health |
47.02; 45.69; 45.54; 47.41; 49.51; 46.79 | — |
| SECONDARY Feetham Family Functioning Survey |
34.96; 36.38; 39.26; 37.44; 38.30; 32.43 | — |
| SECONDARY Resourcefulness Scale |
86.12; 93.59; 87.47; 88.22; 89.17; 93.59 | — |
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. 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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03301831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.