Resourcefulness Training and Decentering on Self-Management in Caregivers of Technology Dependent Children

Completed · Not applicable

Conditions studied: Caregiver, Mindfulness, Mechanical Ventilation Pressure High, Gastrostomy, Chronic Illness

In brief

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.

Key facts

Study ID

NCT02993887

Run by

University Hospitals Cleveland Medical Center

People needed

31

Starts

2017-02-20

Expected to finish

2019-03-30

Last updated by the study team

2019-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;
• aged ≥18 years;
• able to speak and understand English.

You may not qualify if…

• 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.

Where it is running

• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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