Trial Outcomes & Findings for Building Resiliency in Patients Admitted to the Neuroscience Intensive Care Unit and Their Caregivers (NCT NCT03694678)
NCT ID: NCT03694678
Last Updated: 2025-05-28
Results Overview
Feasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
126 participants
Primary outcome timeframe
Baseline
Results posted on
2025-05-28
Participant Flow
Participant milestones
| Measure |
Recovering Together
Dyads who are randomly assigned, via RedCap randomization, to the Recovering Together program received any usual clinic care as determined by their clinicians. Additionally, dyads were invited to participate in 6 30-minute skills sessions. All sessions included both pt and cg. A clinical psychologist delivered the majority of sessions while the PI delivered at least 10% of the sessions. The main intervention goal was to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS.
Recovering Together: The intervention taught resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver participated in all sessions
|
Health Education
Dyads who were randomly assigned, via RedCap randomization, to the control condition received an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that were hypothesized to be responsible for improvement in emotional distress. These sessions included health education content on self-care, including sleep, diet, movement, and exercise. The control entailed 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge. Both patient and caregiver participated in all sessions.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
62
|
|
Overall Study
Patient
|
30
|
31
|
|
Overall Study
Caregiver
|
30
|
31
|
|
Overall Study
COMPLETED
|
56
|
59
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Recovering Together
Dyads who are randomly assigned, via RedCap randomization, to the Recovering Together program received any usual clinic care as determined by their clinicians. Additionally, dyads were invited to participate in 6 30-minute skills sessions. All sessions included both pt and cg. A clinical psychologist delivered the majority of sessions while the PI delivered at least 10% of the sessions. The main intervention goal was to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS.
Recovering Together: The intervention taught resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver participated in all sessions
|
Health Education
Dyads who were randomly assigned, via RedCap randomization, to the control condition received an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that were hypothesized to be responsible for improvement in emotional distress. These sessions included health education content on self-care, including sleep, diet, movement, and exercise. The control entailed 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge. Both patient and caregiver participated in all sessions.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
3
|
Baseline Characteristics
Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
Baseline characteristics by cohort
| Measure |
Recovering Together: Patients
n=29 Participants
Participants who are randomly assigned to the Recovering Together program received any usual clinic care as determined by their clinicians. Additionally, participants were invited to participate in 6 30-minute skills sessions. All sessions included both pt and cg. A clinical psychologist delivered the majority of sessions while the PI delivered at least 10% of the sessions. The main intervention goal was to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS.
Recovering Together: The intervention taught resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver participated in all sessions
|
Recovering Together: Caregivers
n=29 Participants
Participants who are randomly assigned to the Recovering Together program received any usual clinic care as determined by their clinicians. Additionally, participants were invited to participate in 6 30-minute skills sessions. All sessions included both pt and cg. A clinical psychologist delivered the majority of sessions while the PI delivered at least 10% of the sessions. The main intervention goal was to provide dyads with resiliency and interpersonal communication skills necessary to optimize their recovery and reduce emotional distress and PTS.
Recovering Together: The intervention taught resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver participated in all sessions
|
Health Education: Patients
n=29 Participants
Participants randomly assigned to the control condition received an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that were hypothesized to be responsible for improvement in emotional distress. The control entailed 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge. All sessions included both pt and cg.
|
Health Education: Caregivers
n=29 Participants
Participants randomly assigned to the control condition received an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that were hypothesized to be responsible for improvement in emotional distress. The control entailed 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge. All sessions included both pt and cg.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49.3 Years
STANDARD_DEVIATION 16.7 • n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
52.4 Years
STANDARD_DEVIATION 14.3 • n=7 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
50.1 Years
STANDARD_DEVIATION 16.4 • n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
52.1 Years
STANDARD_DEVIATION 14.9 • n=4 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
50.9 Years
STANDARD_DEVIATION 15.5 • n=21 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants • Measure Analysis Population Description: Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
22 Participants
n=7 Participants • Measure Analysis Population Description: Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
12 Participants
n=5 Participants • Measure Analysis Population Description: Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
17 Participants
n=4 Participants • Measure Analysis Population Description: Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
60 Participants
n=21 Participants • Measure Analysis Population Description: Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants • Measure Analysis Population Description: Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
7 Participants
n=7 Participants • Measure Analysis Population Description: Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
17 Participants
n=5 Participants • Measure Analysis Population Description: Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
12 Participants
n=4 Participants • Measure Analysis Population Description: Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
56 Participants
n=21 Participants • Measure Analysis Population Description: Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
0 Participants
n=7 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
0 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
0 Participants
n=4 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
0 Participants
n=21 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
0 Participants
n=7 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
1 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
1 Participants
n=4 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
3 Participants
n=21 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
0 Participants
n=7 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
0 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
0 Participants
n=4 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
0 Participants
n=21 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
4 Participants
n=7 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
2 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
3 Participants
n=4 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
11 Participants
n=21 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
25 Participants
n=7 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
24 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
20 Participants
n=4 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
94 Participants
n=21 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
0 Participants
n=7 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
1 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
1 Participants
n=4 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
3 Participants
n=21 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
0 Participants
n=7 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
1 Participants
n=5 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
4 Participants
n=4 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
5 Participants
n=21 Participants • Total number of participants (patients and caregivers) who completed \>=1 intervention or control session were analyzed and included in baseline population.
|
|
Employment status
Employed full-time
|
18 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Employment status
Retired
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Employment status
Employed part-time
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Employment status
Homemaker
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Employment status
Full-time or part-time student
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Employment status
Other
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: BaselineFeasibility of recruitment will be determined by reporting number of dyads who meet study criteria who enrolled
Outcome measures
| Measure |
Health Education: Caregivers
Caregivers whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Eligible Participants
n=166 Participants
Approached participants who are eligible for the study
|
Health Education
Dyads randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Health Education: Patients
Patients whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
|---|---|---|---|---|
|
Feasibility of Recruitment (Ability to Recruit Dyads)
Participants who enrolled and randomized
|
—
|
122 Participants
|
—
|
—
|
|
Feasibility of Recruitment (Ability to Recruit Dyads)
Participants who declined
|
—
|
40 Participants
|
—
|
—
|
|
Feasibility of Recruitment (Ability to Recruit Dyads)
Participants who enrolled and did not randomize
|
—
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Feasibility of program delivery will be measured at 6 weeksPopulation: Number of dyads who started RT who had at least 1 member complete post treatment assessment
We will report number of sessions completed by each dyad. We will report any technical difficulties with live video delivery
Outcome measures
| Measure |
Health Education: Caregivers
Caregivers whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Eligible Participants
n=30 Participants
Approached participants who are eligible for the study
|
Health Education
n=31 Participants
Dyads randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Health Education: Patients
Patients whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
|---|---|---|---|---|
|
Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads)
Number of dyads who started RT who had at least 1 member complete post treatment assessment
|
—
|
29 dyads
|
31 dyads
|
—
|
|
Feasibility of Intervention Delivery (Ability to Deliver Intervention to Dyads)
Number of dyads who started RT who had neither member complete post treatment assessment
|
—
|
1 dyads
|
0 dyads
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: Score on Credibility and Expectancy Questionnaire
This measure will assess participants' belief that the intervention (or control) will be helpful. The score range is 3-27. Higher scores mean higher perception of credibility or expectancy.
Outcome measures
| Measure |
Health Education: Caregivers
Caregivers whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Eligible Participants
n=58 Participants
Approached participants who are eligible for the study
|
Health Education
n=58 Participants
Dyads randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Health Education: Patients
Patients whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
|---|---|---|---|---|
|
Credibility and Expectancy Questionnaire
Credibility and Expectancy Questionnaire; credibility subscale
|
—
|
22.0 score on a scale
Standard Deviation 4.4
|
20.3 score on a scale
Standard Deviation 4.8
|
—
|
|
Credibility and Expectancy Questionnaire
Credibility and Expectancy Questionnaire; expectancy subscale
|
—
|
19.0 score on a scale
Standard Deviation 5.2
|
19.5 score on a scale
Standard Deviation 5.6
|
—
|
PRIMARY outcome
Timeframe: post intervention (6 weeks after baseline)Population: Score on Client Satisfaction Questionnaire
This measure will assess participants' satisfaction with participation in the study. The score range is 0-12. Higher scores indicate greater satisfaction.
Outcome measures
| Measure |
Health Education: Caregivers
Caregivers whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Eligible Participants
n=58 Participants
Approached participants who are eligible for the study
|
Health Education
n=58 Participants
Dyads randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Health Education: Patients
Patients whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
|---|---|---|---|---|
|
Client Satisfaction Questionnaire
|
—
|
10.65 score on a scale
Standard Deviation 1.18
|
9.87 score on a scale
Standard Deviation 2.70
|
—
|
SECONDARY outcome
Timeframe: baseline to posttest to 3 months follow upMeasures symptoms of emotional distress and estimates diagnoses. The scale has 14 items, 7 assess anxiety and 7 depression. Scores range from 0-21 on each subscale, wtih higher scores indicating more symptoms. Scores greater than 8 indicate clinically significant symptoms.
Outcome measures
| Measure |
Health Education: Caregivers
n=29 Participants
Caregivers whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Eligible Participants
n=29 Participants
Approached participants who are eligible for the study
|
Health Education
n=29 Participants
Dyads randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Health Education: Patients
n=29 Participants
Patients whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
|---|---|---|---|---|
|
Hospital Anxiety and Depression Scale
Baseline: depression
|
4.8 score on a scale
Standard Deviation 3.8
|
8.7 score on a scale
Standard Deviation 4.2
|
7.8 score on a scale
Standard Deviation 2.7
|
7.1 score on a scale
Standard Deviation 4.0
|
|
Hospital Anxiety and Depression Scale
Posttreatment: depression
|
6.1 score on a scale
Standard Deviation 5.4
|
4.0 score on a scale
Standard Deviation 4.1
|
3.28 score on a scale
Standard Deviation 3.37
|
7.2 score on a scale
Standard Deviation 3.7
|
|
Hospital Anxiety and Depression Scale
3-month follow-up: depression
|
7.27 score on a scale
Standard Deviation 5.28
|
3.7 score on a scale
Standard Deviation 3.3
|
2.42 score on a scale
Standard Deviation 2.58
|
7.7 score on a scale
Standard Deviation 5.0
|
|
Hospital Anxiety and Depression Scale
Baseline: anxiety
|
7.0 score on a scale
Standard Deviation 4.7
|
11.1 score on a scale
Standard Deviation 4.7
|
13.2 score on a scale
Standard Deviation 3.9
|
6.3 score on a scale
Standard Deviation 4.0
|
|
Hospital Anxiety and Depression Scale
Posttreatment: anxiety
|
8.1 score on a scale
Standard Deviation 6.1
|
3.3 score on a scale
Standard Deviation 4.1
|
6.0 score on a scale
Standard Deviation 3.8
|
8.5 score on a scale
Standard Deviation 5.2
|
|
Hospital Anxiety and Depression Scale
3-month follow-up: anxiety
|
9.62 score on a scale
Standard Deviation 5.02
|
4.7 score on a scale
Standard Deviation 4.8
|
5.3 score on a scale
Standard Deviation 3.8
|
8.9 score on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: baseline to posttest to 3 months follow upThe PTSD CheckList - Civilian Version measures symptoms of post traumatic stress and determines diagnoses. Scores range from 17-85. Higher scores indicate more severe stress.
Outcome measures
| Measure |
Health Education: Caregivers
n=29 Participants
Caregivers whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Eligible Participants
n=29 Participants
Approached participants who are eligible for the study
|
Health Education
n=29 Participants
Dyads randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Health Education: Patients
n=29 Participants
Patients whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
|---|---|---|---|---|
|
Post Traumatic Checklist
Baseline
|
29.4 score on a scale
Standard Deviation 12.0
|
41.6 score on a scale
Standard Deviation 12.9
|
43.2 score on a scale
Standard Deviation 10.7
|
29.3 score on a scale
Standard Deviation 12.1
|
|
Post Traumatic Checklist
Posttreatment
|
35.9 score on a scale
Standard Deviation 16.6
|
26.4 score on a scale
Standard Deviation 10.8
|
39.3 score on a scale
Standard Deviation 9.8
|
34.6 score on a scale
Standard Deviation 12.1
|
|
Post Traumatic Checklist
3-month follow-up
|
37.7 score on a scale
Standard Deviation 16.1
|
28.2 score on a scale
Standard Deviation 10.1
|
27.3 score on a scale
Standard Deviation 7.7
|
41.7 score on a scale
Standard Deviation 16.0
|
SECONDARY outcome
Timeframe: baseline to posttest to 3 months follow upThe MOCS-A measures various coping strategies such as relaxation or adaptive thinking. Scores range from 0 to 52, and higher scores indicate greater self-perceived proficiency with these skills.
Outcome measures
| Measure |
Health Education: Caregivers
n=29 Participants
Caregivers whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Eligible Participants
n=29 Participants
Approached participants who are eligible for the study
|
Health Education
n=29 Participants
Dyads randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Health Education: Patients
n=29 Participants
Patients whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
|---|---|---|---|---|
|
Measures of Coping Style Part A
Baseline
|
2.5 score on a scale
Standard Deviation .9
|
2.2 score on a scale
Standard Deviation .8
|
2.3 score on a scale
Standard Deviation .6
|
2.6 score on a scale
Standard Deviation .9
|
|
Measures of Coping Style Part A
Posttest
|
2.4 score on a scale
Standard Deviation 1.2
|
2.7 score on a scale
Standard Deviation .8
|
2.6 score on a scale
Standard Deviation 1.1
|
2.4 score on a scale
Standard Deviation .8
|
|
Measures of Coping Style Part A
3-month follow-up
|
2.3 score on a scale
Standard Deviation 1.0
|
2.5 score on a scale
Standard Deviation .7
|
2.5 score on a scale
Standard Deviation .9
|
2.2 score on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: baseline to post test to 3 months follow upMeasures mindfulness skills used in daily life. The scale ranges from 12 to 48 with higher scores indicating higher mindfulness.
Outcome measures
| Measure |
Health Education: Caregivers
n=29 Participants
Caregivers whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Eligible Participants
n=29 Participants
Approached participants who are eligible for the study
|
Health Education
n=29 Participants
Dyads randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Health Education: Patients
n=29 Participants
Patients whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
|---|---|---|---|---|
|
Cognitive and Affective Mindfulness Scale Revised
Baseline
|
36.4 score on a scale
Standard Deviation 7.6
|
34.2 score on a scale
Standard Deviation 7.0
|
34.6 score on a scale
Standard Deviation 5.8
|
35.1 score on a scale
Standard Deviation 7.8
|
|
Cognitive and Affective Mindfulness Scale Revised
Posttreatment
|
36.7 score on a scale
Standard Deviation 8.5
|
36.7 score on a scale
Standard Deviation 7.7
|
36.3 score on a scale
Standard Deviation 6.5
|
35.0 score on a scale
Standard Deviation 10.7
|
|
Cognitive and Affective Mindfulness Scale Revised
3-month follow-up
|
33.3 score on a scale
Standard Deviation 9.4
|
35.5 score on a scale
Standard Deviation 7.9
|
36.3 score on a scale
Standard Deviation 7.5
|
32.3 score on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: Baseline, post treatment, 3-month follow-upThe Dyadic Relationship Scale (DRS) has 2 sub scales that assess dyadic strains and dyadic positive interaction. Scales on each sub scale range from 1 to 4, with higher scores indicating great severity of the relevant construct.
Outcome measures
| Measure |
Health Education: Caregivers
n=29 Participants
Caregivers whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Eligible Participants
n=29 Participants
Approached participants who are eligible for the study
|
Health Education
n=29 Participants
Dyads randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
Health Education: Patients
n=29 Participants
Patients whose dyad are randomly assigned to the control condition will receive an educational program that mimics the dose and duration of the Recovering Together Program but without teaching any of the resiliency or interpersonal communication skills that are hypothesized to be responsible for improvement in emotional distress. The control will entail 2 in-person dyadic visits in the NICU and 4 dyadic virtual visits after discharge.
|
|---|---|---|---|---|
|
Dyadic Relationship Scale
Dyadic strain: 3-month follow-up
|
2.2 score on a scale
Standard Deviation .8
|
1.9 score on a scale
Standard Deviation .8
|
2.2 score on a scale
Standard Deviation .8
|
2.0 score on a scale
Standard Deviation .9
|
|
Dyadic Relationship Scale
Positive interactions: baseline
|
3.3 score on a scale
Standard Deviation .4
|
3.1 score on a scale
Standard Deviation .5
|
3.0 score on a scale
Standard Deviation .5
|
3.2 score on a scale
Standard Deviation .6
|
|
Dyadic Relationship Scale
Positive interactions: 3-month follow-up
|
3.0 score on a scale
Standard Deviation .7
|
3.2 score on a scale
Standard Deviation .6
|
3.2 score on a scale
Standard Deviation .6
|
2.82 score on a scale
Standard Deviation .67
|
|
Dyadic Relationship Scale
Dyadic strain: baseline
|
1.8 score on a scale
Standard Deviation .7
|
2.0 score on a scale
Standard Deviation .8
|
2.0 score on a scale
Standard Deviation .7
|
2.0 score on a scale
Standard Deviation .78
|
|
Dyadic Relationship Scale
Dyadic strain: posttreatment
|
2.1 score on a scale
Standard Deviation .9
|
1.6 score on a scale
Standard Deviation .6
|
2.01 score on a scale
Standard Deviation .8
|
2.0 score on a scale
Standard Deviation .9
|
|
Dyadic Relationship Scale
Positive interactions: posttreatment
|
3.2 score on a scale
Standard Deviation .7
|
3.4 score on a scale
Standard Deviation .6
|
3.3 score on a scale
Standard Deviation .5
|
2.97 score on a scale
Standard Deviation .77
|
Adverse Events
Recovering Together: Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Recovering Together: Caregivers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Education: Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Health Education: Caregivers
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