Spinal Cord InjuriesNCT02083601
Caring for Caregivers: Supporting Caregivers of Youth With Spinal Cord Injury
A study testing Parent Forum and Psychological support in people with Spinal Cord Injuries, run by Erin Hayes Kelly, PhD at 1 site in United States.
Trial summary
The current study will implement and evaluate a multi-component, psychoeducational intervention for caregivers of children with spinal cord injury (SCI) ages 7-12. Two hypotheses will be tested. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Parent Forum and Psychological support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Dec 2016
- 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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary caregivers of youth with SCI ages 7-12 years.
- Youth sustained their SCI at least one year ago.
- Both the caregiver and child are able to speak English.
- Both the caregiver and child are able and willing to sign informed consent/assent and Health Insurance Portability and Accountability Act (HIPAA) compliant research authorization.
Who cannot join
- Caregiver or child has significant cognitive limitations and/or psychiatric comorbidities. These conditions will be identified by a clinical psychologist or physician.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Chicago, Illinois, 60707
About this study
The current study will implement and evaluate a multi-component, psychoeducational intervention for caregivers of children with spinal cord injury (SCI) ages 7-12. Two hypotheses will be tested. First, caregivers who participate in the intervention group will demonstrate better outcomes than caregivers in the control group. Second, children with SCI whose caregivers participate in the intervention group will demonstrate better outcomes than children with SCI whose caregivers participate in the control group.
Read the detailed description
The primary objective of this study is to implement and evaluate an intervention for caregivers of children with spinal cord injury (SCI) ages 7-12. A further objective of this pilot study is to identify which outcomes are being affected by the intervention. Past research has highlighted psychoeducational intervention (i.e., interventions including both educational/skills-building components and psychological support) as most effective in terms of impacting caregiver functioning. The current study will recruit 44 caregivers and their children with SCI. All caregivers will participate in a 2-day Parent Forum, an in-person educational session. Caregivers will then be randomly assigned to receive monthly phone calls from a mental health professional ("intervention group") or no additional targeted support ("control group"). We expect that caregivers who participate in the intervention group and their children will demonstrate better outcomes than caregivers in the control group and their children.
- Conditions
- Spinal Cord Injuries
- Being tested
- Parent Forum, Psychological support
- Keywords
- Caregivers, Spinal Cord Injuries, Psychology, Educational, Counseling, Outcome Assessment (Health Care)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent ForumBehavioural
In-person psychoeducational workshop that provides education (including problem-solving training) and psychological/peer support for caregivers of youth with SCI.
Psychological supportBehavioural
Outreach from a mental health professional in the form of monthly phone calls for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Psychological Support | Experimental | The intervention group will participate in the 2-day, in-person Parent Forum and receive monthly phone calls from a mental health professional for 12 months. Receives: Behavioral: Parent Forum; Behavioral: Psychological support |
| No Psychological Support | Other | This comparison group will attend the 2-day, in-person Parent Forum but will not receive long-term psychological support. Receives: Behavioral: Parent Forum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal changes in Social Problem Solving Inventory-Revised (SPSI-R) over time
This short-form will be completed by parents to assess their social problem solving skills. There are four subscales: positive and negative problem orientation, rational problem solving, impulsivity/carelessness style, and avoidance style.
Measured: Baseline, Immediately after Parent Forum, 6 months, 12 months, 18 months
Longitudinal changes in Satisfaction with Life Scale (SWLS) over time
This self-report measure will be used to assess subjective life satisfaction or QOL among caregivers.
Measured: Baseline, 6 months, 12 months, 18 months
Longitudinal changes in Hospital Anxiety and Depression Scale (HADS) over time
This self-report measure will be used to assess depression, anxiety, and emotional distress.
Measured: Baseline, 6 months, 12 months, 18 months
Longitudinal changes in Social support/Social integration questions over time
Consistent with past research, caregivers will be asked about their satisfaction with social support, and the number of relatives, friends, neighbors, and others that they see or hear from at least once each month, feel close to, or feel they can call on for help with things like chores or transportation.
Measured: Baseline, 6 months, 12 months, 18 months
Longitudinal changes in Caregiver Burden Interview over time
A modified version of the brief 12- item version of the Caregiver Burden Interview will be administered to caregivers. Originally developed for caregivers of cognitively impaired older adults, this survey will be adapted for parents of children with SCI.
Measured: Baseline, 6 months, 12 months, 18 months
Longitudinal changes in Medical Outcomes Study Short Form Health Survey (SF-36) over time
This self-report measure will be used to assess caregivers' health perceptions and general well-being. The SF-36 including the following scales: physical functioning, physical role functioning, pain, general health, energy/fatigue, social functioning, and emotional role functioning and mental health.
Measured: Baseline, 6 months, 12 months, 18 months
Longitudinal changes in Revised Scale for Caregiving Self-Efficacy over time
A modified version of this self-report scale will be used to assess the belief that the caregiver has about his or her ability to successfully carry out certain kinds of behaviors. This measure includes 15 items within 3 subscales: self-efficacy for obtaining respite, responding to disruptive patient behaviors, and controlling upsetting thoughts about caregiving. Originally created for caregivers of cognitively impaired older adults, this survey will also be adapted for parents of children with SCI.
Measured: Baseline, Immediately after Parent Forum, 6 months, 12 months, 18 months
Longitudinal changes in Physical Health Form over time
This survey was developed by the current research team and will be completed by the caregiver about their child's bowel and bladder incontinence and the presence of pressure ulcers.
Measured: Baseline, 6 months, 12 months, 18 months
Longitudinal changes in Pediatric Quality of Life Inventory (PedsQL) over time
Caregivers will complete the proxy-report versions of the general core scales to assess four areas of their child's health-related QOL: physical, emotional, social, and school functioning. Children will complete the self-report general core scales to assess four areas of their health-related QOL: physical, emotional, social, and school functioning.
Measured: Baseline, 6 months, 12 months, 18 months
Evaluation tool to assess intervention satisfaction over time
Caregivers will be asked about their satisfaction with the intervention components (including resulting peer relationships), including the Parent Forum (for all caregivers) and outreach from the mental health professional (for caregivers in the intervention group only).
Measured: Immediately after Parent Forum, 6 months, 12 months, 18 months
Longitudinal changes in Faces Pain Scale/Visual Analog Scale over time
These 10-point pain scales will be used to assess pain intensity in youth ages 7-8 and 9-12, respectively. These children will be asked about pain intensity at the time of survey completion (acute pain).
Measured: Baseline, 6 months, 12 months, 18 months
Longitudinal changes in Children's Depression Inventory: Second Edition-Short Form (CDI-2-SF) over time
The short form of this self-report measure yields an overall depression score and will be administered to children ages 7-12.
Measured: Baseline, 6 months, 12 months, 18 months
Longitudinal changes in Revised Children's Manifest Anxiety Scale: Second Edition-Short Form (RCMAS-2-SF) over time
The short form of this self-report measure is designed to assess the level and nature of anxiety with subscales assessing physiological anxiety, worry, social anxiety, defensiveness, and inconsistent responding. The RCMAS-2-SF will be administered to children ages 7-12.
Measured: Baseline, 6 months, 12 months, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erin Hayes Kelly, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Responsible party
- Sponsor-investigator, Erin Hayes Kelly, PhD, Shriners Hospitals for Children
- Investigators
- Erin H Kelly, PhD, Principal investigator, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083601
- Sponsor's protocol ID
- 288993
- Status last verified
- Apr 2018
- First submitted
- 4 Mar 2014
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caring for Caregivers: Supporting Caregivers of Youth With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02083601
- Acronym / sponsor ID
- 288993
- Conditions
- Spinal Cord Injuries
- Keywords
- Caregivers, Spinal Cord Injuries, Psychology, Educational, Counseling, Outcome Assessment (Health Care)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Erin Hayes Kelly, PhDUniversity, hospital or other
- Collaborators
- The Craig H. Neilsen Foundation
- Study start
- Apr 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Mar 2014 (estimated)
- 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 current study will implement and evaluate a multi-component, psychoeducational intervention for caregivers of children with spinal cord injury (SCI) ages 7-12. Two hypotheses will be tested. First, caregivers who participate in the intervention group will demonstrate better outcomes than caregivers in the control group. Second, children with SCI whose caregivers participate in the intervention group will demonstrate better outcomes than children with SCI whose caregivers participate in the control group.
Detailed description
The primary objective of this study is to implement and evaluate an intervention for caregivers of children with spinal cord injury (SCI) ages 7-12. A further objective of this pilot study is to identify which outcomes are being affected by the intervention. Past research has highlighted psychoeducational intervention (i.e., interventions including both educational/skills-building components and psychological support) as most effective in terms of impacting caregiver functioning. The current study will recruit 44 caregivers and their children with SCI. All caregivers will participate in a 2-day Parent Forum, an in-person educational session. Caregivers will then be randomly assigned to receive monthly phone calls from a mental health professional ("intervention group") or no additional targeted support ("control group"). We expect that caregivers who participate in the intervention group and their children will demonstrate better outcomes than caregivers in the control group and their children.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological Support | Experimental | Behavioral: Parent Forum, Behavioral: Psychological supportThe intervention group will participate in the 2-day, in-person Parent Forum and receive monthly phone calls from a mental health professional for 12 months. |
| No Psychological Support | Other | Behavioral: Parent ForumThis comparison group will attend the 2-day, in-person Parent Forum but will not receive long-term psychological support. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Primary caregivers of youth with SCI ages 7-12 years.
- Youth sustained their SCI at least one year ago.
- Both the caregiver and child are able to speak English.
- Both the caregiver and child are able and willing to sign informed consent/assent and Health Insurance Portability and Accountability Act (HIPAA) compliant research authorization.
Key exclusion criteria (1 listed)
- Caregiver or child has significant cognitive limitations and/or psychiatric comorbidities. These conditions will be identified by a clinical psychologist or physician.
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 |
|---|---|---|
| Parent ForumIn-person psychoeducational workshop that provides education (including problem-solving training) and psychological/peer support for caregivers of youth with SCI. | Behavioural | No Psychological Support, Psychological Support |
| Psychological supportOutreach from a mental health professional in the form of monthly phone calls for 12 months. | Behavioural | Psychological Support |
Primary outcome
Longitudinal changes in Social Problem Solving Inventory-Revised (SPSI-R) over time
Time frame: Baseline, Immediately after Parent Forum, 6 months, 12 months, 18 months
This short-form will be completed by parents to assess their social problem solving skills. There are four subscales: positive and negative problem orientation, rational problem solving, impulsivity/carelessness style, and avoidance style.
Longitudinal changes in Satisfaction with Life Scale (SWLS) over time
Time frame: Baseline, 6 months, 12 months, 18 months
This self-report measure will be used to assess subjective life satisfaction or QOL among caregivers.
Longitudinal changes in Hospital Anxiety and Depression Scale (HADS) over time
Time frame: Baseline, 6 months, 12 months, 18 months
This self-report measure will be used to assess depression, anxiety, and emotional distress.
Longitudinal changes in Social support/Social integration questions over time
Time frame: Baseline, 6 months, 12 months, 18 months
Consistent with past research, caregivers will be asked about their satisfaction with social support, and the number of relatives, friends, neighbors, and others that they see or hear from at least once each month, feel close to, or feel they can call on for help with things like chores or transportation.
Longitudinal changes in Caregiver Burden Interview over time
Time frame: Baseline, 6 months, 12 months, 18 months
A modified version of the brief 12- item version of the Caregiver Burden Interview will be administered to caregivers. Originally developed for caregivers of cognitively impaired older adults, this survey will be adapted for parents of children with SCI.
Longitudinal changes in Medical Outcomes Study Short Form Health Survey (SF-36) over time
Time frame: Baseline, 6 months, 12 months, 18 months
This self-report measure will be used to assess caregivers' health perceptions and general well-being. The SF-36 including the following scales: physical functioning, physical role functioning, pain, general health, energy/fatigue, social functioning, and emotional role functioning and mental health.
Longitudinal changes in Revised Scale for Caregiving Self-Efficacy over time
Time frame: Baseline, Immediately after Parent Forum, 6 months, 12 months, 18 months
A modified version of this self-report scale will be used to assess the belief that the caregiver has about his or her ability to successfully carry out certain kinds of behaviors. This measure includes 15 items within 3 subscales: self-efficacy for obtaining respite, responding to disruptive patient behaviors, and controlling upsetting thoughts about caregiving. Originally created for caregivers of cognitively impaired older adults, this survey will also be adapted for parents of children with SCI.
Longitudinal changes in Physical Health Form over time
Time frame: Baseline, 6 months, 12 months, 18 months
This survey was developed by the current research team and will be completed by the caregiver about their child's bowel and bladder incontinence and the presence of pressure ulcers.
Longitudinal changes in Pediatric Quality of Life Inventory (PedsQL) over time
Time frame: Baseline, 6 months, 12 months, 18 months
Caregivers will complete the proxy-report versions of the general core scales to assess four areas of their child's health-related QOL: physical, emotional, social, and school functioning. Children will complete the self-report general core scales to assess four areas of their health-related QOL: physical, emotional, social, and school functioning.
Evaluation tool to assess intervention satisfaction over time
Time frame: Immediately after Parent Forum, 6 months, 12 months, 18 months
Caregivers will be asked about their satisfaction with the intervention components (including resulting peer relationships), including the Parent Forum (for all caregivers) and outreach from the mental health professional (for caregivers in the intervention group only).
Longitudinal changes in Faces Pain Scale/Visual Analog Scale over time
Time frame: Baseline, 6 months, 12 months, 18 months
These 10-point pain scales will be used to assess pain intensity in youth ages 7-8 and 9-12, respectively. These children will be asked about pain intensity at the time of survey completion (acute pain).
Longitudinal changes in Children's Depression Inventory: Second Edition-Short Form (CDI-2-SF) over time
Time frame: Baseline, 6 months, 12 months, 18 months
The short form of this self-report measure yields an overall depression score and will be administered to children ages 7-12.
Longitudinal changes in Revised Children's Manifest Anxiety Scale: Second Edition-Short Form (RCMAS-2-SF) over time
Time frame: Baseline, 6 months, 12 months, 18 months
The short form of this self-report measure is designed to assess the level and nature of anxiety with subscales assessing physiological anxiety, worry, social anxiety, defensiveness, and inconsistent responding. The RCMAS-2-SF will be administered to children ages 7-12.
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 24 Apr 2018.
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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.
Erin H Kelly, PhD principal investigator
Shriners Hospitals for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Forum and Psychological support in people with Spinal Cord Injuries, run by Erin Hayes Kelly, PhD 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 4 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 24 Apr 2018. 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?
Longitudinal changes in Social Problem Solving Inventory-Revised (SPSI-R) over time (time frame: Baseline, Immediately after Parent Forum, 6 months, 12 months, 18 months). The study lists 13 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 24 Apr 2018.