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Completed

NCT Number: NCT02083601

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

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shriners Hospitals for Children

Chicago, Illinois, 60707, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parent Forum

Behavioral

In-person psychoeducational workshop that provides education (including problem-solving training) and psychological/peer support for caregivers of youth with SCI.

psychological support

Behavioral

Outreach from a mental health professional in the form of monthly phone calls for 12 months.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. 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).

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

Erin Hayes Kelly, PhD

Other

Collaborators

  • The Craig H. Neilsen Foundation

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 11, 2014
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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