NCT06173700

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 18, 2023

Completed
Last Updated

December 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

November 30, 2023

Last Update Submit

December 7, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Attendance

    across the 7 weeks of the group

  • Client Satisfaction Questionnaire-8 (CSQ-8)

    at the end of the 7 weeks

Study Arms (1)

Single Group Intervention

EXPERIMENTAL

7-week web-based group with problem solving training

Behavioral: web-based group problem solving and coping training

Interventions

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."

Single Group Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

United Spinal Association

Washington D.C., District of Columbia, 20010, United States

Location

Study Officials

  • Elena Donoso Brown, PhD

    Duquesne University

    STUDY CHAIR
  • Elena Martino, BS

    Duquesne University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 18, 2023

Study Start

June 6, 2023

Primary Completion

July 25, 2023

Study Completion

August 9, 2023

Last Updated

December 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations