Resourcefulness Training and Decentering on Self-Management in Caregivers of Technology Dependent Children
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/12/2018 |
| Start Date: | February 20, 2017 |
| End Date: | May 30, 2019 |
The Effects of Resourcefulness Training Intervention and Decentering on Self-Management of Stress in Caregivers of Children With Complex Chronic Conditions Dependent on Lifesaving Medical Technology: A Pilot Study
The investigators will conduct a randomized clinical trial pilot study to examine the
effectiveness of a theoretically based intervention (called ReMind) encompassing two key
components: (a) Resourcefulness Training for parent caregivers, and (b) daily mindfulness
meditation delivered using a smart phone application (Stop, Breathe & Think™) with an
intervention (Mind Only) that consists only of daily mindfulness meditation. Both components
of the intervention have been tested separately (but not combined) and both interventions can
be self-tailored, which meets the vital need for these caregivers to engage in
self-management activities when it is convenient for them. The investigators will test the
two arms of the intervention in 30 parents of technology-dependent children, 15 parents in
each group. The investigators will collect mixed data at baseline, 3 months and 6 months
after subject enrollment to describe changes in proximal and distal outcomes. The
investigators aim to:
1. Evaluate the intermediate (3 month) and long-term (6 month) effects of the ReMind and
Mind Only interventions on study mediators (HPA Axis Function and stress, cognitive
factors, resourcefulness) and determine if there are different effects between ReMind
and Mind Only interventions.
2. Evaluate the differences in distal psychological (Mental Health Related Quality of Life,
Depressive Cognitions, Depressive Symptoms, Anxiety, Caregiver Burden), physical
(Physical Health Related Quality of Life), and cost outcomes between subjects in the
ReMind and Mind Only arms over time.
3. Determine the moderating effects of parents' social support, demographics (age, gender,
family income) and children's functional status on (a) proximal outcomes and the
relationship between (a) the intervention arm and distal outcomes, and (b) HPA Axis
Function, stress, cognitive factors and distal outcomes.
4. Evaluate the impact of decentering on the association between the interventions and the
proximal and distal outcomes.
5. Explore differences in neurological processing (DMN and TPN) and decentering in proximal
and distal outcomes associated with each intervention.
effectiveness of a theoretically based intervention (called ReMind) encompassing two key
components: (a) Resourcefulness Training for parent caregivers, and (b) daily mindfulness
meditation delivered using a smart phone application (Stop, Breathe & Think™) with an
intervention (Mind Only) that consists only of daily mindfulness meditation. Both components
of the intervention have been tested separately (but not combined) and both interventions can
be self-tailored, which meets the vital need for these caregivers to engage in
self-management activities when it is convenient for them. The investigators will test the
two arms of the intervention in 30 parents of technology-dependent children, 15 parents in
each group. The investigators will collect mixed data at baseline, 3 months and 6 months
after subject enrollment to describe changes in proximal and distal outcomes. The
investigators aim to:
1. Evaluate the intermediate (3 month) and long-term (6 month) effects of the ReMind and
Mind Only interventions on study mediators (HPA Axis Function and stress, cognitive
factors, resourcefulness) and determine if there are different effects between ReMind
and Mind Only interventions.
2. Evaluate the differences in distal psychological (Mental Health Related Quality of Life,
Depressive Cognitions, Depressive Symptoms, Anxiety, Caregiver Burden), physical
(Physical Health Related Quality of Life), and cost outcomes between subjects in the
ReMind and Mind Only arms over time.
3. Determine the moderating effects of parents' social support, demographics (age, gender,
family income) and children's functional status on (a) proximal outcomes and the
relationship between (a) the intervention arm and distal outcomes, and (b) HPA Axis
Function, stress, cognitive factors and distal outcomes.
4. Evaluate the impact of decentering on the association between the interventions and the
proximal and distal outcomes.
5. Explore differences in neurological processing (DMN and TPN) and decentering in proximal
and distal outcomes associated with each intervention.
Design Overview. The investigators will conduct a two-arm Randomized Clinical Trial to
compare the effects of the ReMind with the Mind interventions on psychological and physical
health outcomes and cognitive task switching between the DMN and TPN neural networks in
Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI). The full
ReMind intervention involves daily self-tailored mindful meditation application focused on
kindness and compassion for 4 weeks with self-selected frequency of use thereafter. The
application that is being used is theoretically constructed and tested and can be delivered
on a smart phone app for free (iPad, computer as well). ReMind also includes five
resourcefulness training aspects: 1) one face-to-face session for teaching social
(help-seeking) and personal (self-help) resourcefulness skills, 2) ongoing web access to
video vignettes of parents of technology-dependent children describing the application of
resourcefulness skills in daily life, 3) 4 weeks of skills' reinforcement using daily journal
writing by the parents, 4) weekly phone calls from the intervention nurse over 4 weeks after
face-to-face intervention training. The Mind Only intervention includes only the meditation
component. Thus, the investigators will be able to see if the addition of Resourcefulness
Training will significantly impact proximal outcomes (self management behaviors) such as
appraised sleep quality, positive health practices and distal outcomes such as psychological
health (Mental Health Related Quality of Life, depressive cognitions, anxiety, caregiver
burden), physical health (Physical Health Related Quality of Life), and economic costs.
Sample. A purposive sample of 30 parent caregivers of technology-dependent children (n=15
ReMind, n=15 Mind Only) seen at outpatient clinics (Pulmonology, Gastroenterology,
Trach/Vent). The investigators have used this patient population in prior work. Given the
availability of potential subjects and the investigator's experience with this population,
the investigators anticipate little difficulty in recruiting 30 subjects.
compare the effects of the ReMind with the Mind interventions on psychological and physical
health outcomes and cognitive task switching between the DMN and TPN neural networks in
Functional Magnetic Resonance Imaging (fMRI) and Diffusion Tensor Imaging (DTI). The full
ReMind intervention involves daily self-tailored mindful meditation application focused on
kindness and compassion for 4 weeks with self-selected frequency of use thereafter. The
application that is being used is theoretically constructed and tested and can be delivered
on a smart phone app for free (iPad, computer as well). ReMind also includes five
resourcefulness training aspects: 1) one face-to-face session for teaching social
(help-seeking) and personal (self-help) resourcefulness skills, 2) ongoing web access to
video vignettes of parents of technology-dependent children describing the application of
resourcefulness skills in daily life, 3) 4 weeks of skills' reinforcement using daily journal
writing by the parents, 4) weekly phone calls from the intervention nurse over 4 weeks after
face-to-face intervention training. The Mind Only intervention includes only the meditation
component. Thus, the investigators will be able to see if the addition of Resourcefulness
Training will significantly impact proximal outcomes (self management behaviors) such as
appraised sleep quality, positive health practices and distal outcomes such as psychological
health (Mental Health Related Quality of Life, depressive cognitions, anxiety, caregiver
burden), physical health (Physical Health Related Quality of Life), and economic costs.
Sample. A purposive sample of 30 parent caregivers of technology-dependent children (n=15
ReMind, n=15 Mind Only) seen at outpatient clinics (Pulmonology, Gastroenterology,
Trach/Vent). The investigators have used this patient population in prior work. Given the
availability of potential subjects and the investigator's experience with this population,
the investigators anticipate little difficulty in recruiting 30 subjects.
Inclusion Criteria:
1. parent (biological, adoptive, or foster mother, father, grandmother, or grandfather)
caregiver for a child aged ≤17 years dependent on medical technology (mechanical
ventilators, intravenous nutrition/medication, respiratory or nutritional support) at
home;
2. aged ≥18 years;
3. able to speak and understand English.
Exclusion Criteria:
1. currently practicing mindfulness-based interventions (yoga, meditation, deep
breathing)
2 history of a medical condition or procedure that is contraindicated for imaging
(i.e. cardiac pacemaker, sternal wires, or metal implants);
3 claustrophobia requiring anxiolytics or sedation
4 Pregnancy at time of recruitment.
5 If participant becomes pregnant during the follow up period the participant will be
excluded from all imaging studies.
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