Caring for Caregivers: Supporting Caregivers of Youth With Spinal Cord Injury

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Shriners Hospitals for Children
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Erin Hayes Kelly, PhD, Shriners Hospitals for Children
ClinicalTrials.gov Identifier:
NCT02083601
First received: March 4, 2014
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Spinal Cord Injuries
Behavioral: Parent Forum
Behavioral: Psychological support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Caring for Caregivers: Supporting Caregivers of Youth With Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 88
Study Start Date: April 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Psychological Support
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.
Behavioral: Parent Forum
In-person psychoeducational workshop that provides education (including problem-solving training) and psychological/peer support for caregivers of youth with SCI.
Behavioral: Psychological support
Outreach from a mental health professional in the form of monthly phone calls for 12 months.
No Psychological Support
This comparison group will attend the 2-day, in-person Parent Forum but will not receive long-term psychological support.
Behavioral: Parent Forum
In-person psychoeducational workshop that provides education (including problem-solving training) and psychological/peer support for caregivers of youth with SCI.

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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Caregiver or child has significant cognitive limitations and/or psychiatric comorbidities. These conditions will be identified by a clinical psychologist or physician.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02083601

Contacts
Contact: Erin H Kelly, PhD 773-385-5853 ekelly@shrinenet.org
Contact: Anne L Riordan, MA 773-385-5511 ariordan@shrinenet.org

Locations
United States, Illinois
Shriners Hospitals for Children Not yet recruiting
Chicago, Illinois, United States, 60707
Principal Investigator: Erin H Kelly, PhD         
Sponsors and Collaborators
Erin Hayes Kelly, PhD
The Craig H. Neilsen Foundation
Investigators
Principal Investigator: Erin H Kelly, PhD Shriners Hospitals for Children - Chicago
  More Information

No publications provided

Responsible Party: Erin Hayes Kelly, PhD, Principal Investigator, Shriners Hospitals for Children
ClinicalTrials.gov Identifier: NCT02083601     History of Changes
Other Study ID Numbers: 288993
Study First Received: March 4, 2014
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:
Caregivers
Spinal Cord Injuries
Psychology, Educational
Counseling
Outcome Assessment (Health Care)

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on August 21, 2014