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

NCT ID: NCT02083601

Last Updated: 2018-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Parent Forum

Intervention Type BEHAVIORAL

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

Psychological support

Intervention Type BEHAVIORAL

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

No Psychological Support

This comparison group will attend the 2-day, in-person Parent Forum but will not receive long-term psychological support.

Group Type OTHER

Parent Forum

Intervention Type BEHAVIORAL

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

Interventions

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Parent Forum

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

Intervention Type BEHAVIORAL

Psychological support

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Craig H. Neilsen Foundation

OTHER

Sponsor Role collaborator

Erin Hayes Kelly, PhD

OTHER

Sponsor Role lead

Responsible Party

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Erin Hayes Kelly, PhD

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Erin H Kelly, PhD

Role: PRINCIPAL_INVESTIGATOR

Shriners Hospitals for Children

Locations

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Shriners Hospitals for Children

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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288993

Identifier Type: -

Identifier Source: org_study_id

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