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Interventions for Parent Caregivers of Injured Military/Veteran Personnel

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ClinicalTrials.gov Identifier: NCT03309046
Recruitment Status : Recruiting
First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Linda O. Nichols, Ph.D., Memphis VA Medical Center

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.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Brain Injuries, Traumatic Other: REACH Individual Session Other: Education Webinar Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interventions for Parent Caregivers of Injured Military/Veteran Personnel
Actual Study Start Date : April 1, 2017
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Other: REACH Individual Session
Individual telephone session with parent
Active Comparator: 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.
Other: Education Webinar
Videos with information on caregiving



Primary Outcome Measures :
  1. Depression - Patient Health Questionnaire - 9 (PHQ-9) [ Time Frame: 6 months ]
    The PHQ-9 has 9 items based on the DSM-IV depression diagnostic criteria. Time Frame: All questions refer to the past two weeks.Scaling: 0 (not at all) to 3 (nearly every day). Scores are summed to characterize depression as minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), or high/severe (20-27). On the PHQ-9, major depressive syndrome is suggested if #1 or #2 and 5 or more items are ranked positive (at least "more than half the days," count #9 if present at all). Other Depressive Syndrome suggested if #1 or #2 and two, three, or four of #1-9 are at least "More than half the days" (count #9 if present at all).

  2. Anxiety - Generalized Anxiety Disorder (GAD-7). Time Frame: All questions refer to the past two weeks. [ Time Frame: 6 months ]

    the GAD-7 contains a 7-item checklist of symptoms of GAD. All questions refer to the past two weeks. Scaling: 0 (not at all) to 3 (nearly every day)

    # of Items: 7-items. Scaling: 0 (not at all) to 3 (nearly every day). Scoring for each item ranges from 0 (not at all) to 3 (nearly every day) for an overall score of 0 to 21; higher scores equal more anxiety. Several cut points have been put forward for different purposes. Spitzer et al recommend a cut point of 10 to indentify cases of GAD. They also suggest cut points of 5, 10, and 15 to represent mild, moderate and severe similar to levels of depression on the PHQ (Spitzer et al., 2006). A cut point of 8 may also be used to detect possible cases of an anxiety disorder (Kroenke et al., 2007).


  3. Burden - Zarit Burden Interview (ZBI-12) [ Time Frame: 6 months ]

    Scaling: 0 (Never) to 4 (Nearly Always)

    • of items: 12 items Scaling: 0 (Never) to 4 (Nearly Always)
    • of items: 12 items Scaling: 0 (Never) to 4 (Nearly Always). # of items: 12 items. 0 (Never), 1 (Rarely), 2 (Sometimes), 3 (Quite Frequently), to 4 (Nearly Always)



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309046


Contacts
Contact: Carolyn Clark, MA 800-636-8262 ext 5079 carolyn.clark3@va.gov
Contact: Evelyn Wright, MS 800-636-8262 ext 2083 Evelyn.Wright2@va.gov

Locations
United States, Tennessee
Memphis VA Medical Center Recruiting
Memphis, Tennessee, United States, 38104
Contact: Associate Chief of Staff for Research    800-636-8262 ext 7336      
Contact: Committee Coordinator    800-636-8262 ext 7267    Fredrika.curry@va.gov   
Sub-Investigator: Marshall J Graney, PhD         
Sub-Investigator: Robert Burns, MD         
Sub-Investigator: Jennifer L Martindale-Adams, EdD         
Sponsors and Collaborators
Memphis VA Medical Center
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Linda O Nichols, PhD Memphis VAMC

Responsible Party: Linda O. Nichols, Ph.D., Co-Director Caregiver Center, Memphis VA Medical Center
ClinicalTrials.gov Identifier: NCT03309046     History of Changes
Other Study ID Numbers: 14029002
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Linda O. Nichols, Ph.D., Memphis VA Medical Center:
Parents
Caregivers
Veterans

Additional relevant MeSH terms:
Brain Injuries
Stress Disorders, Post-Traumatic
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders