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

NCT02083601 | Completed

• 1 other identifier: 288993
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Cord Injuries

Keywords

Caregivers; Spinal Cord Injuries; Psychology, Educational; Counseling; Outcome Assessment (Health Care)

Outcome Measures

Primary Outcomes (13)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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.

  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.

  Baseline, 6 months, 12 months, 18 months

Study Arms (2)

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.

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.

Behavioral: Parent Forum

Interventions

Parent Forum BEHAVIORAL

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

No Psychological Support; Psychological Support

Psychological support BEHAVIORAL

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

Psychological Support

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Caregiver or child has significant cognitive limitations and/or psychiatric comorbidities. These conditions will be identified by a clinical psychologist or physician.

Sponsors & Collaborators

• Erin Hayes Kelly, PhD: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Shriners Hospitals for Children

Chicago, Illinois, 60707, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Erin H Kelly, PhD

  Shriners Hospitals for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 11, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

US (1)