Interventions for Parent Caregivers of Injured Military/Veteran Personnel
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|ClinicalTrials.gov Identifier: NCT03309046|
Recruitment Status : Active, not recruiting
First Posted : October 13, 2017
Last Update Posted : November 22, 2019
|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)|
|Actual Enrollment :||163 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|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|
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
- 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)
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
|United States, Tennessee|
|Memphis VA Medical Center|
|Memphis, Tennessee, United States, 38104|
|Principal Investigator:||Linda O Nichols, PhD||Memphis VAMC|