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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06173700
Other study ID # 2023/04/8
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 6, 2023
Est. completion date August 9, 2023

Study information

Verified date November 2023
Source Duquesne University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date August 9, 2023
Est. primary completion date July 25, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
web-based group problem solving and coping 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."

Locations

Country Name City State
United States United Spinal Association Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Duquesne University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brief COPE 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
Primary Caregiver Self-Assessment Questionnaire 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
Primary Knowledge Check 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 Attendance number of sessions attended across the 7 weeks of the group
Secondary Client Satisfaction Questionnaire-8 (CSQ-8) 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
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