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

NCT02993887 | Completed

• 1 other identifier: 10-16-10
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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. 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. 4.Evaluate the impact of decentering on the association between the interventions and the proximal and distal outcomes.
5. 5.Explore differences in neurological processing (DMN and TPN) and decentering in proximal and distal outcomes associated with each intervention.

Conditions

Caregiver; Mindfulness; Mechanical Ventilation Pressure High; Gastrostomy; Chronic Illness

Keywords

Caregiver; Technology Dependent Children; Resourcefulness; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Mental & Physical Health Related Quality of Life at 3 Months & 6 Months

  Measure using the Patient Reported Outcomes Measurement Information System (PROMIS)-29

  Measured at baseline with follow up at 3 months, 6 months

Secondary Outcomes (2)

• Change from Baseline Appraised Sleep Quality at 3 months and 6 months

  Measured at baseline with follow up at 3 months, 6 months

• Change from Baseline Positive Health Practices at 3 months and 6 months

  Measured at baseline with follow up at 3 months, 6 months

Study Arms (2)

Mindfulness

PLACEBO COMPARATOR

Mindfulness (Decentering) only using the Stop, Breathe, Think Smart Phone application

Behavioral: Mindfulness

Resourcefulness and Mindfulness

EXPERIMENTAL

Resourcefulness Training (a cognitive behavioral intervention that teaches self-help and help-seeking skills) and Mindfulness using the Stop, Think, Breathe app.

Behavioral: Resourcefulness Training; Behavioral: Mindfulness

Interventions

Resourcefulness Training BEHAVIORAL

This intervention will include a one time face to face instruction on Resourcefulness Training that entails 8 self-help and help-seeking skills plus viewing short video vignettes of caregivers describing application of the resourcefulness skills. In addition, participants will use daily journaling to describe application of the resourcefulness skills in their daily caregiving with their technology-dependent child.

Resourcefulness and Mindfulness

Mindfulness BEHAVIORAL

The mindfulness intervention will include the use of an app daily via Stop, Think, Breathe.

Mindfulness; Resourcefulness and Mindfulness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• history of a medical condition or procedure that is contraindicated for imaging (i.e. cardiac pacemaker, sternal wires, or metal implants);
• claustrophobia requiring anxiolytics or sedation
• Pregnancy at time of recruitment.
• If participant becomes pregnant during the follow up period the participant will be excluded from all imaging studies.

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Case Western Reserve University: collaborator
• The Cleveland Clinic: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Publications (1)

• Moore SM, Musil CM, Alder ML, Pignatiello G, Higgins P, Webel A, Wright KD. Building a Research Data Repository for Chronic Condition Self-Management Using Harmonized Data. Nurs Res. 2020 Jul/Aug;69(4):254-263. doi: 10.1097/NNR.0000000000000435.

  PMID: 32205788 DERIVED

MeSH Terms

Conditions

Chronic Disease

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Valerie A Toly, PhD

  Case Western Reserve University, Frances Payne Bolton School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nursing

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 15, 2016
• Study Start: February 20, 2017
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

US (1)