- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06173700
Empowering Parental Caregivers
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20010
- United Spinal Association
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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."
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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
|
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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).
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Before the group began 7 weeks after start of group
|
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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.
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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).
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at the end of the 7 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Elena Donoso Brown, PhD, Duquesne University
- Principal Investigator: Elena Martino, BS, Duquesne University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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