CaregiversNCT06173700
Empowering Parental Caregivers
A study testing web-based group problem solving and coping training in people with Caregivers, run by Duquesne University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers
- What is being tested?
- web-based group problem solving and coping training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to 9 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
United Spinal Association
Washington D.C., District of Columbia, 20010
About this study
Official title: 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.
- Conditions
- Caregivers
- Being tested
- web-based group problem solving and coping training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based group problem solving and coping trainingBehavioural
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."
| Study group | Role | What they receive |
|---|---|---|
| Single Group Intervention | Experimental | 7-week web-based group with problem solving training Receives: Behavioral: web-based group problem solving and coping training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief COPE
The Brief COPE is a 28-item self-report measure that determines the participants' styles of coping (Carver,1997).
Measured: 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).
Measured: 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.
Measured: Before the group began 7 weeks after start of group
Secondary outcomes (2)
Attendance
number of sessions attended
Measured: across the 7 weeks of the group
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).
Measured: at the end of the 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start6 Jun 2023
- Primary completion25 Jul 2023
- Study completion9 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Donoso Brown, PhD, Study chair, Duquesne UniversityElena Martino, BS, Principal investigator, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173700
- Sponsor's protocol ID
- 2023/04/8
- Status last verified
- Nov 2023
- First submitted
- 30 Nov 2023
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Parental Caregivers: A Virtual Support Group With Problem Solving Training for Parents/Guardians of Children With SCI/D
- ClinicalTrials.gov ID
- NCT06173700
- Acronym / sponsor ID
- 2023/04/8
- Conditions
- Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 9 Aug 2023 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Intervention | Experimental | Behavioral: web-based group problem solving and coping training7-week web-based group with problem solving training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-based group problem solving and coping trainingThe 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." | Behavioural | Single Group Intervention |
Primary outcome
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).
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).
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.
2 secondary outcomes
Attendance
Time frame: across the 7 weeks of the group
Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: at the end of the 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Donoso Brown, PhD study chair
Duquesne University
Elena Martino, BS principal investigator
Duquesne University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web-based group problem solving and coping training in people with Caregivers, run by Duquesne University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief COPE (time frame: Before the group began, 7 weeks after start of group). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2023.