Interventions for Parent Caregivers of Injured Military/Veteran Personnel

NCT ID: NCT03309046

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 163 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2020-03-31

Brief Summary

This randomized clinical trial will test a behavioral caregiving intervention that has been used successfully for dementia and spinal cord injury caregivers to provide services to stressed and burdened parent caregivers of post 9/11 service members/veterans. This intervention is six intensive individual sessions that will teach problem solving, cognitive restructuring and stress reduction targeted to an individual assessment of the care dyad's needs. It will be compared to another method of delivering content, education webinar sessions, which are analogous to the usual standard of care and will function as an attention control arm. The objective of the study is to determine which of these delivery mechanisms is more effective at helping parent caregivers of injured post 9/11 returning troops to improve their depression, anxiety, and burden, and to determine the feasibility of using individual sessions with this population of caregivers.

Conditions

Stress Disorders, Post-Traumatic; Brain Injuries, Traumatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

REACH Individual Session

The individual sessions intervention focuses on education, skills building, and support. It will be delivered in six sessions by telephone over three months. A Caregiver Notebook will include comprehensive materials for all sessions and topics. Treatment fidelity will be monitored and ensured through assessment of intervention delivery, receipt, and enactment. The intervention is targeted and individualized to the concerns of the specific caregiver and care recipient through a risk assessment. The Risk Assessment (RA) assesses the main caregiving risk areas for the specific caregiving dyad. The RA is used to tailor the intervention for care recipient behaviors or safety issues and/or caregiver centered issues/concerns related to health, physical and emotional well being, and/or social support.

Group Type: EXPERIMENTAL

REACH Individual Session

Intervention Type: OTHER

Individual telephone session with parent

Education Webinar

For the education webinar sessions, topics addressing each of the caregiving risk factors topics but without the skills building or cognitive restructuring components present in the individual intervention sessions will be available online in webinars. The education webinar sessions will focus on general information about post 9/11 concerns, problem behaviors, caregiver health, caregiver emotional well-being, and red flags. Education webinar session participants will not receive the Caregiver Notebook until they have completed their 6 month interviews. Parents will be able to view all 6 webinars at any time during the first 3 months. Each session will last approximately thirty minutes through PowerPoint slide presentation format with a pre-recorded script.

Group Type: ACTIVE_COMPARATOR

Education Webinar

Intervention Type: OTHER

Videos with information on caregiving

Interventions

REACH Individual Session

Individual telephone session with parent

Intervention Type: OTHER

Education Webinar

Videos with information on caregiving

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Identify as a parent who serves as the primary/main caregiver for a post 9/11 service member or veteran with a diagnosis of traumatic brain injury or post traumatic stress disorder or physical injury and at least 1 activity of daily living limitation or 2 or more instrumental of daily living limitations;

2. provide 3 hours or more of care per day for at least 6 months;

3. endorse at least 2 caregiving stress behaviors (overwhelmed, often needing to cry, angry/frustrated, cut off from family/friends, moderate/high levels of stress, and declining health); and

4. have a telephone.

5. Internet access is desirable but not mandatory.

Exclusion Criteria

1. current diagnosis of schizophrenia or other major mental illness; or

2. auditory impairment that would make telephone use difficult

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Memphis VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Linda O. Nichols, Ph.D.

Co-Director Caregiver Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linda O Nichols, PhD

Role: PRINCIPAL_INVESTIGATOR

Memphis VAMC

Locations

Memphis VA Medical Center

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

14029002

Identifier Type: -

Identifier Source: org_study_id