Recruitment

Recruitment Status
Completed
Estimated Enrollment
88

Inclusion Criterias

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.
Primary caregivers of youth with SCI ages 7-12 years.
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.
Primary caregivers of youth with SCI ages 7-12 years.
Both the caregiver and child are able to speak English.
Youth sustained their SCI at least one year ago.

Exclusion Criterias

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

Summary

Conditions
Spinal Cord Injuries
Type
Interventional
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Supportive Care

Participation Requirements

Age
Between 7 years and 125 years
Gender
Both males and females

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 psychoeduca...

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.

Inclusion Criterias

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.
Primary caregivers of youth with SCI ages 7-12 years.
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.
Primary caregivers of youth with SCI ages 7-12 years.
Both the caregiver and child are able to speak English.
Youth sustained their SCI at least one year ago.

Exclusion Criterias

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

Locations

Chicago, Illinois, 60707
Chicago, Illinois, 60707

Tracking Information

NCT #
NCT02083601
Collaborators
The Craig H. Neilsen Foundation
Investigators
  • Principal Investigator: Erin H Kelly, PhD Shriners Hospitals for Children
  • Erin H Kelly, PhD Shriners Hospitals for Children