The Mental Health Effects of a Mindfulness App in Parents of a Child With Medical Complexity

NCT05925868 | Completed

• 1 other identifier: 186-SB22-056
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The number of children with special health care needs (CSHCN) in the US is nearly 20% of children representing approximately 14.6 million children nationally. A subgroup of CSHCN are children who have the most intensive healthcare needs known as children with a medical complexity (CMC). Parents of CMC experience many challenges. In addition to typical caregiver tasks, parents of a CMC may experience added stress and are more likely to experience higher rates of anxiety, depression, and post-traumatic stress disorder than parents of healthy children. This project aims to explore the acceptability and feasibility of a mindfulness mobile application for parents of a CMC as well as determine the effectiveness of mindfulness application use on stress, depression, and family management in parents of a CMC. Forty-five participants will be recruited and given access to a mindfulness application and instructed to use it at least 4 days a week for at least 10 minutes. Parents will fill out questionnaires on app usage, as well as stress, depression, and family management. This work will be accomplished through a pilot single arm approach.

Conditions

Depression; Family Dynamics; Stress, Psychological; Chronic Illness; Parents

Keywords

mindfulness app; parents; child with chronic illness; stress; depression; family management; Headspace

Outcome Measures

Primary Outcomes (4)

• To assess the feasibility of a mindfulness mobile application for parents of a CMC

  The feasibility scale will be used to assess the feasibility of the app during and after the study. This is based on a questionnaire by Rung, Oral, Berghammer, Peters (2020)35. It consists of closed-ended and open-ended questions that ask parents to rate the app, whether they would recommend it, and asks about their experience using the app and whether they intend to continue its use.

  4 weeks

• To describe the efficacy of a mindfulness app on stress in parents of a child with CMC

  The Pediatric Inventory for Parents (PIP) will be used to assess stress before and after mindfulness app use. The PIP has 42 questions, scored 1-5 with higher scores indicating higher stress.

  4 weeks

• To describe the efficacy of a mindfulness app on depression

  The PHQ-9 will be used to describe the effects of a mindfulness app on depression scores. The PHQ includes 9 questions ranging from 0-3 with higher numbers indicating a higher depression score.

  4 weeks

• To describe the efficacy of a mindfulness app on family management

  The Family Management Measure (FaMM) will be used to describe the effects of a mindfulness app on family management. There are 45 items, ranging from 1-5 with higher scores indicating higher difficulty with family management

  4 weeks

Study Arms (1)

Mobile app

EXPERIMENTAL

Parents will be given access the Headspace, a mobile mindfulness app, and instructed to use it at least 4 days a week for a minimum of 10 minutes

Behavioral: mindfulness app

Interventions

mindfulness app BEHAVIORAL

Parents will use the mindfulness app, Headspace, for at least 10 minutes on 4 days/week.

Also known as: Headspace

Mobile app

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older of a child with medical complexity with daily access to a mobile device (i.e. smartphone or tablet)
• score \> 4 on Perceived Stress Scale-4 (PSS-4)
• able to read English (the mindfulness app is only available in English).

You may not qualify if:

• \- a current mindfulness practice (i. e., practice ≥15 min per day of meditation or yoga within the past 6 months).

Sponsors & Collaborators

• Boise State University: lead
• Case Western Reserve University: collaborator

Study Sites (1)

St. Luke's Regional Hospital

Boise, Idaho, 83725, United States

Location

MeSH Terms

Conditions

Depression; Stress, Psychological; Chronic Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Cara Gallegos, PhD, BSN

  Boise State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: June 29, 2023
• Study Start: February 1, 2023
• Primary Completion: November 23, 2023
• Study Completion: November 23, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available after data has been collected.
• Access Criteria: Requests will be reviewed by the PI. IRB and a data transfer agreement will be required

Locations

US (1)