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Interventions for Parent Caregivers of Injured Military/Veteran Personnel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03309046
Recruitment Status : Active, not recruiting
First Posted : October 13, 2017
Last Update Posted : November 22, 2019
Sponsor:
Collaborator:
U.S. Army Medical Research and Development Command
Information provided by (Responsible Party):
Linda O. Nichols, Ph.D., Memphis VA Medical Center

Tracking Information
First Submitted Date  ICMJE October 5, 2017
First Posted Date  ICMJE October 13, 2017
Last Update Posted Date November 22, 2019
Actual Study Start Date  ICMJE April 1, 2017
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2017)
  • 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).
  • 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).
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Interventions for Parent Caregivers of Injured Military/Veteran Personnel
Official Title  ICMJE Interventions for Parent Caregivers of Injured Military/Veteran Personnel
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stress Disorders, Post-Traumatic
  • Brain Injuries, Traumatic
Intervention  ICMJE
  • Other: REACH Individual Session
    Individual telephone session with parent
  • Other: Education Webinar
    Videos with information on caregiving
Study Arms  ICMJE
  • 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.
    Intervention: Other: REACH Individual Session
  • 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.
    Intervention: Other: Education Webinar
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 21, 2019)
163
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2017)
160
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date February 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03309046
Other Study ID Numbers  ICMJE 14029002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Linda O. Nichols, Ph.D., Memphis VA Medical Center
Study Sponsor  ICMJE Memphis VA Medical Center
Collaborators  ICMJE U.S. Army Medical Research and Development Command
Investigators  ICMJE
Principal Investigator: Linda O Nichols, PhD Memphis VAMC
PRS Account Memphis VA Medical Center
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP