Trial Outcomes & Findings for Interventions for Parent Caregivers of Injured Military/Veteran Personnel (NCT NCT03309046)
NCT ID: NCT03309046
Last Updated: 2023-10-23
Results Overview
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). 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). Score ranges from 0-27. Higher scores indicate greater depression. 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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
163 participants
Primary outcome timeframe
6 months
Results posted on
2023-10-23
Participant Flow
Participant milestones
| Measure |
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.
REACH Individual Session: 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.
Education Webinar: Videos with information on caregiving
|
|---|---|---|
|
Overall Study
STARTED
|
82
|
81
|
|
Overall Study
COMPLETED
|
78
|
64
|
|
Overall Study
NOT COMPLETED
|
4
|
17
|
Reasons for withdrawal
| Measure |
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.
REACH Individual Session: 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.
Education Webinar: Videos with information on caregiving
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
17
|
Baseline Characteristics
Interventions for Parent Caregivers of Injured Military/Veteran Personnel
Baseline characteristics by cohort
| Measure |
REACH Individual Session
n=82 Participants
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.
REACH Individual Session: Individual telephone session with parent
|
Education Webinar
n=81 Participants
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.
Education Webinar: Videos with information on caregiving
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.2 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
60.1 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
76 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
82 participants
n=5 Participants
|
81 participants
n=7 Participants
|
163 participants
n=5 Participants
|
|
Depression
|
6.0 units on a scale
STANDARD_DEVIATION 4.3 • n=5 Participants
|
7.3 units on a scale
STANDARD_DEVIATION 5.8 • n=7 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Anxiety
|
6.6 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 4.6 • n=7 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
|
Burden
|
15.7 units on a scale
STANDARD_DEVIATION 8.6 • n=5 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 8.9 • n=7 Participants
|
16.8 units on a scale
STANDARD_DEVIATION 8.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: intention-to-treat, with participants analyzed according to initial arm assignments
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). 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). Score ranges from 0-27. Higher scores indicate greater depression. 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).
Outcome measures
| Measure |
REACH Individual Session
n=82 Participants
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.
REACH Individual Session: Individual telephone session with parent
|
Education Webinar
n=81 Participants
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.
Education Webinar: Videos with information on caregiving
|
|---|---|---|
|
Depression - Patient Health Questionnaire - 9 (PHQ-9)
|
4.4 units on a scale
Standard Deviation 3.4
|
6.3 units on a scale
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: intention to treat
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. A cut point of 10 identifies cases of generalized anxiety disorder. Cut points of 5, 10, and 15 represent mild, moderate and severe anxiety.
Outcome measures
| Measure |
REACH Individual Session
n=82 Participants
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.
REACH Individual Session: Individual telephone session with parent
|
Education Webinar
n=81 Participants
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.
Education Webinar: Videos with information on caregiving
|
|---|---|---|
|
Anxiety - Generalized Anxiety Disorder (GAD-7). Time Frame: All Questions Refer to the Past Two Weeks.
|
5.3 units on a scale
Standard Deviation 4.3
|
6.8 units on a scale
Standard Deviation 5.1
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: intention to treat
\# of items: 12 items Scaling: 0 (Never) to 4 (Nearly Always) Total score ranges from 0-48, Higher scores indicate greater burden with \> 17 indicating severe/high burden.
Outcome measures
| Measure |
REACH Individual Session
n=82 Participants
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.
REACH Individual Session: Individual telephone session with parent
|
Education Webinar
n=81 Participants
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.
Education Webinar: Videos with information on caregiving
|
|---|---|---|
|
Burden - Zarit Burden Interview (ZBI-12)
|
13.4 units on a scale
Standard Deviation 8.5
|
16.1 units on a scale
Standard Deviation 9.7
|
Adverse Events
REACH Individual Session
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Education Webinar
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place