Clinical trial NCT02083601: Caring for Caregivers: Supporting Caregivers of Youth With Spinal Cord Injury
Official title: Caring for Caregivers: Supporting Caregivers of Youth With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Caregivers
Spinal Cord Injuries
Psychology, Educational
Counseling
Outcome Assessment (Health Care)
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
Collaborators: name: The Craig H. Neilsen Foundation
First posted: 2014-03-11
Enrollment: 53
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: Longitudinal changes in Social Problem Solving Inventory-Revised (SPSI-R) over time
timeFrame: Baseline, Immediately after Parent Forum, 6 months, 12 months, 18 months
measure: Longitudinal changes in Satisfaction with Life Scale (SWLS) over time
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Longitudinal changes in Hospital Anxiety and Depression Scale (HADS) over time
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Longitudinal changes in Social support/Social integration questions over time
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Longitudinal changes in Caregiver Burden Interview over time
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Longitudinal changes in Medical Outcomes Study Short Form Health Survey (SF-36) over time
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Longitudinal changes in Revised Scale for Caregiving Self-Efficacy over time
timeFrame: Baseline, Immediately after Parent Forum, 6 months, 12 months, 18 months
measure: Longitudinal changes in Physical Health Form over time
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Longitudinal changes in Pediatric Quality of Life Inventory (PedsQL) over time
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Evaluation tool to assess intervention satisfaction over time
timeFrame: Immediately after Parent Forum, 6 months, 12 months, 18 months
measure: Longitudinal changes in Faces Pain Scale/Visual Analog Scale over time
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Longitudinal changes in Children's Depression Inventory: Second Edition-Short Form (CDI-2-SF) over time
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Longitudinal changes in Revised Children's Manifest Anxiety Scale: Second Edition-Short Form (RCMAS-2-SF) over time
timeFrame: Baseline, 6 months, 12 months, 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shriners Hospitals for Children
state: Illinois
Study officials:
affiliation: Shriners Hospitals for Children
name: Erin H Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
References: