Empowering Parental Caregivers

December 7, 2023 updated by: Duquesne University

Empowering Parental Caregivers: A Virtual Support Group With Problem Solving Training for Parents/Guardians of Children With SCI/D

The goal of this clinical trial was to learn about the feasibility and pilot outcome measures in caregivers of children with spinal cord injury who completed a 7-week problem-solving training web-based group. The main question it aims to answer is: What is the feasibility of a seven-week, occupational therapist-facilitated, web-based support group with problem-solving training for parental caregivers of children with SCI?

Participants participated 1 time a week for seven weeks in a web-based group group:

  • learning about the FOCUS problem-solving model
  • applying positive coping and problem-solving strategies to current issues.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • United Spinal Association

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • one must be a parent or guardian of a child with a spinal cord injury or disorder, be that child's primary caregiver, and be 18 years or older.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Group Intervention
7-week web-based group with problem solving training
The group included one-hour, weekly Zoom sessions, that were facilitated by an occupational therapy doctoral candidate (first author) for 7 consecutive weeks. During the first session, the candidate explained adaptive and maladaptive coping strategies and asked each participant to identify one adaptive coping strategy that they currently use and will continue to use in the future. The candidate then explained the FOCUS problem-solving approach. For each session afterward, the candidate presented a topic-related scenario for parents to identify an effective solution using the FOCUS steps (APA, 2011). Parent-chosen topics included recreation, assistive technology, motivating and advocating, physical activity, skin integrity, and adaptive fashion. The general process of the meetings is presented in Figure 1. After every meeting the candidate sent out a summary of resources that were discussed during the meeting, ultimately putting them all together in an "Empowering Caregiver Guide."

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief COPE
Time Frame: Before the group began, 7 weeks after start of group
The Brief COPE is a 28-item self-report measure that determines the participants' styles of coping (Carver,1997).
Before the group began, 7 weeks after start of group
Caregiver Self-Assessment Questionnaire
Time Frame: Before the group began 7 weeks after start of group
The Caregiver Self-Assessment Questionnaire is a brief, 18-question self-assessment that asks respondents to consider the impact of caregiving on their stress levels, physical body, and mental health (American Society for Geriatrics, 2015).
Before the group began 7 weeks after start of group
Knowledge Check
Time Frame: Before the group began 7 weeks after start of group
The Knowledge Check was a measure developed by the research team with guidance from Obst and Porter's guide for school personnel (n.d.). The research team generated the items around three themes: general SCI knowledge, FOCUS problem-solving skills, and coping knowledge.
Before the group began 7 weeks after start of group

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attendance
Time Frame: across the 7 weeks of the group
number of sessions attended
across the 7 weeks of the group
Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame: at the end of the 7 weeks
The CSQ-8 is an eight-item standardized questionnaire that aims to understand the participants' general satisfaction with the sessions, developed by Attkisson & Greenfield (2004). It is a highly effective tool to measure client satisfaction with program contents and has high internal consistency (Attkisson & Greenfield, 2004).
at the end of the 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Elena Donoso Brown, PhD, Duquesne University
  • Principal Investigator: Elena Martino, BS, Duquesne University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2023

Primary Completion (Actual)

July 25, 2023

Study Completion (Actual)

August 9, 2023

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Estimated)

December 18, 2023

Study Record Updates

Last Update Posted (Estimated)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2023/04/8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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