Resourcefulness Intervention With Parents of Technology-Dependent Children

NCT03301831 | Completed Results DMC

• 2 other identifiers: 08-10-301R15NR017302-01
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Multiple Chronic Conditions; Family Caregivers

Keywords

Parents; Technology-Dependent Child; Resourcefulness

Outcome Measures

Primary Outcomes (3)

• 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.

  From baseline to 6 weeks, 3 months, and 6 months post-enrollment

• Medical Outcomes Short Form Health Survey (SF-12) Physical Health

  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.

  From baseline to 6 weeks, 3 months, and 6 months post-enrollment

• Medical Outcomes Short Form Health Survey (SF-12) Mental Health

  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.

  From baseline to 6 weeks, 3 months, and 6 months post-enrollment

Secondary Outcomes (2)

• Feetham Family Functioning Survey

  From baseline to 6 weeks, 3 months, and 6 months post-enrollment

• Resourcefulness Scale

  From baseline to 6 weeks, 3 months, and 6 months post-enrollment

Study Arms (2)

Resourcefulness Training Intervention

EXPERIMENTAL

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

Attention Control

NO INTERVENTION

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.

Interventions

Resourcefulness Training BEHAVIORAL

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

Resourcefulness Training Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Depression; Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Valerie Boebel Toly, PhD, RN, CPNP
• Organization: Case Western Reserve University

vab@case.edu

(216) 368-3082

Study Officials

• Valerie A Toly, PhD

  Frances Payne Bolton School of Nursing, Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor- UH Research Associate

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

Study Record Dates

• First Submitted: September 24, 2017
• First Posted: October 4, 2017
• Study Start: February 5, 2018
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: October 25, 2021
• Results First Posted: October 25, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)