Resourcefulness Intervention With Parents of Technology-Dependent Children

Intervention Pilot With Parents of Technology-Dependent Children

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03301831

Enrollment

Registered

2017-10-04

Start date

2018-02-05

Completion date

2019-12-09

Last updated

2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Symptoms, Family Caregivers, Multiple Chronic Conditions

Keywords

Parents, Technology-Dependent Child, Resourcefulness

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.

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.

Interventions

BEHAVIORALResourcefulness Training

Cognitive-behavioral intervention that includes personal and social resourcefulness skills.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

2-arm RCT with participants randomized to either the intervention or attention control group.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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

Measure	Time frame	Description
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
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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. Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.	46
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.	47
Total	93

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	5	3
Overall Study	Protocol Violation	4	0
Overall Study	Withdrawal by Subject	11	0

Baseline characteristics

Characteristic	Resourcefulness Training Intervention	Total	Attention Control
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	3 Participants	2 Participants
Age, Categorical Between 18 and 65 years	45 Participants	90 Participants	45 Participants
Age, Continuous	39.5 Years STANDARD_DEVIATION 9.9	39.1 Years STANDARD_DEVIATION 10.3	38.7 Years STANDARD_DEVIATION 10.8
Center for Epidemiological Studies- Depression	19 units on a scale	18.5 units on a scale	18.04 units on a scale
Depressive Cognitions Scale	7.7 units on a scale	8.03 units on a scale	8.4 units on a scale
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants	6 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	43 Participants	87 Participants	44 Participants
Feetham Family Functioning Survey	43.63 units on a scale STANDARD_DEVIATION 29.39	41.58 units on a scale STANDARD_DEVIATION 27.14	39.57 units on a scale STANDARD_DEVIATION 24.91
General Mental Health	42.6 units on a scale	42.5 units on a scale	42.45 units on a scale
General Physical Health	51.32 units on a scale	50.4 units on a scale	49.48 units on a scale
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Black or African American	10 Participants	24 Participants	14 Participants
Race (NIH/OMB) More than one race	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants	8 Participants	4 Participants
Race (NIH/OMB) White	30 Participants	58 Participants	28 Participants
Region of Enrollment United States	46 participants	93 participants	47 participants
Resourcefulness Scale	84.96 Score on a scale	86.24 Score on a scale	87.52 Score on a scale
Sex: Female, Male Female	38 Participants	78 Participants	40 Participants
Sex: Female, Male Male	8 Participants	15 Participants	7 Participants
Zarit Burden Scale	20.1 units on a scale	20 units on a scale	19.9 units on a scale

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 46	0 / 47
other Total, other adverse events	0 / 46	0 / 47
serious Total, serious adverse events	0 / 47	0 / 46

Outcome results

Primary

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.