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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Behavioral: Parent Forum; Behavioral: Psychological support

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60707
      • Shriners Hospitals for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Erin Hayes Kelly, PhD
• Collaborators: The Craig H. Neilsen Foundation
• Investigators: Principal Investigator: Erin H Kelly, PhD, Shriners Hospitals for Children

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (Estimate): March 11, 2014

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Counseling; Caregivers; Spinal Cord Injuries; Outcome Assessment (Health Care); Psychology, Educational
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 288993