Resourcefulness Intervention With Parents of Technology-Dependent Children

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03301831
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 93
• Location: 1
• Arms: 2
• Actual Duration (Months): 22.1
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Symptoms; Multiple Chronic Conditions; Family Caregivers	Behavioral: Resourcefulness Training	N/A

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

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 2-arm RCT with participants randomized to either the intervention or attention control group.2-arm RCT with participants randomized to either the intervention or attention control group.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Intervention Pilot With Parents of Technology-Dependent Children
• Actual Study Start Date: Feb 5, 2018
• Actual Primary Completion Date: Dec 9, 2019
• Actual Study Completion Date: Dec 9, 2019

Arms and Interventions

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.	Behavioral: Resourcefulness Training; 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.

Outcome Measures

Primary Outcome Measures

1. Depressive Cognitions Scale [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.

2. Medical Outcomes Short Form Health Survey (SF-12) Physical Health [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.

3. Medical Outcomes Short Form Health Survey (SF-12) Mental Health [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.

Secondary Outcome Measures

1. Feetham Family Functioning Survey [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

2. Resourcefulness Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106-5065

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Valerie A Toly, PhD, Frances Payne Bolton School of Nursing, Case Western Reserve University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 1, 2018

More Information

Publications

None provided.

• Responsible Party: Valerie Toly, Assistant Professor- UH Research Associate, University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT03301831
• Other Study ID Numbers: 08-10-30; 1R15NR017302-01
• First Posted: Oct 4, 2017
• Last Update Posted: Oct 25, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Valerie Toly, Assistant Professor- UH Research Associate, University Hospitals Cleveland Medical Center: Parents; Technology-Dependent Child; Resourcefulness
• Additional relevant MeSH terms: Multiple Chronic Conditions; Depression

Study Results

Participant Flow

Arm/Group Title	Resourcefulness Training Intervention	Attention Control
Arm/Group Description	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. Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.	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.
Period Title: Overall Study
STARTED	46	47
COMPLETED	26	44
NOT COMPLETED	20	3

Baseline Characteristics

Arm/Group Title	Resourcefulness Training Intervention	Attention Control	Total
Arm/Group Description	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. Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.	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.	Total of all reporting groups
Overall Participants	46	47	93
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	45 97.8%	45 95.7%	90 96.8%
>=65 years	1 2.2%	2 4.3%	3 3.2%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	39.5 (9.9)	38.7 (10.8)	39.1 (10.3)
Sex: Female, Male (Count of Participants)
Female	38 82.6%	40 85.1%	78 83.9%
Male	8 17.4%	7 14.9%	15 16.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 6.5%	3 6.4%	6 6.5%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	43 93.5%	44 93.6%	87 93.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 2.1%	1 1.1%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	10 21.7%	14 29.8%	24 25.8%
White	30 65.2%	28 59.6%	58 62.4%
More than one race	2 4.3%	0 0%	2 2.2%
Unknown or Not Reported	4 8.7%	4 8.5%	8 8.6%
Region of Enrollment (participants) [Number]
United States	46 100%	47 100%	93 100%
General Physical Health (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	51.32	49.48	50.4
General Mental Health (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	42.6	42.45	42.5
Center for Epidemiological Studies- Depression (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	19	18.04	18.5
Resourcefulness Scale (Score on a scale) [Mean (Full Range) ]
Mean (Full Range) [Score on a scale]	84.96	87.52	86.24
Depressive Cognitions Scale (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	7.7	8.4	8.03
Feetham Family Functioning Survey (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	43.63 (29.39)	39.57 (24.91)	41.58 (27.14)
Zarit Burden Scale (units on a scale) [Mean (Full Range) ]
Mean (Full Range) [units on a scale]	20.1	19.9	20

Outcome Measures

1. Primary Outcome

Title	Depressive Cognitions Scale
Description	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.
Time Frame	From baseline to 6 weeks, 3 months, and 6 months post-enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Resourcefulness Training Intervention	Attention Control
Arm/Group Description	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. Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.	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.
Measure Participants	46	47
6 Weeks Post Enrollment Timepoint	6.46	6.97
3 Months Post Enrollment Timepoint	6.32	7.28
6 Months Post Enrollment Timepoint	5.65	7.93

2. Primary Outcome

Title	Medical Outcomes Short Form Health Survey (SF-12) Physical Health
Description	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.
Time Frame	From baseline to 6 weeks, 3 months, and 6 months post-enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Resourcefulness Training Intervention	Attention Control
Arm/Group Description	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. Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.	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.
Measure Participants	46	47
6 Weeks Post Enrollement Timepoint 2	52.7	50.77
3 Months Post Enrollment Timepoint 3	54.49	49.46
6 Months Post Enrollment Timepoint 4	51.49	49.81

3. Primary Outcome

Title	Medical Outcomes Short Form Health Survey (SF-12) Mental Health
Description	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.
Time Frame	From baseline to 6 weeks, 3 months, and 6 months post-enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Resourcefulness Training Intervention	Attention Control
Arm/Group Description	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. Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.	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.
Measure Participants	46	47
6 Weeks Post-Enrollment, Timepoint 2	47.02	45.69
3 Months Post-Enrollment, Timepoint 3	45.54	47.41
6 Weeks Post-Enrollment, Timepoint 4	49.51	46.79

4. Secondary Outcome

Title	Feetham Family Functioning Survey
Description	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
Time Frame	From baseline to 6 weeks, 3 months, and 6 months post-enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Resourcefulness Training Intervention	Attention Control
Arm/Group Description	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. Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.	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.
Measure Participants	46	47
6 Weeks Post Enrollment Timepoint	34.96 (22.01)	36.38 (22.32)
3 Months Post Enrollment Timepoint	39.26 (22.83)	37.44 (24.32)
6 Months Post Enrollment Timepoint	38.30 (23.66)	32.43 (19.55)

5. Secondary Outcome

Title	Resourcefulness Scale
Description	Subjective survey of participants' personal and social resourcefulness. Score range is 0-140, where a higher score indicates greater resourcefulness.
Time Frame	From baseline to 6 weeks, 3 months, and 6 months post-enrollment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Resourcefulness Training Intervention	Attention Control
Arm/Group Description	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. Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.	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.
Measure Participants	46	47
6 Weeks Post Enrollment Timepoint	86.12	93.59
3 Months Post Enrollment Timepoint	87.47	88.22
6 Months Post Enrollment Timepoint	89.17	93.59

Adverse Events

Time Frame	No adverse events were reported during the 6 month data collection period.
Adverse Event Reporting Description	The definitions do not differ in this context because no adverse events or serious adverse events were reported during the 6 month data collection period.
Arm/Group Title	Resourcefulness Training Intervention		Attention Control
Arm/Group Description	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. Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.		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.
All Cause Mortality
	Resourcefulness Training Intervention		Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/47 (0%)
Serious Adverse Events
	Resourcefulness Training Intervention		Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/47 (0%)		0/46 (0%)
Other (Not Including Serious) Adverse Events
	Resourcefulness Training Intervention		Attention Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/46 (0%)		0/47 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.