Trial Outcomes & Findings for Resourcefulness Intervention With Parents of Technology-Dependent Children (NCT NCT03301831)
NCT ID: NCT03301831
Last Updated: 2021-10-25
Results Overview
Subjective measure of participant depressive cognitions- precursor of depressive symptoms. Score range for the instrument is 0-40, where a higher score indicates greater depressive cognition.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
From baseline to 6 weeks, 3 months, and 6 months post-enrollment
Results posted on
2021-10-25
Participant Flow
Participant milestones
| Measure |
Resourcefulness Training Intervention
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
|
Attention Control
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
|
|---|---|---|
|
Overall Study
STARTED
|
46
|
47
|
|
Overall Study
COMPLETED
|
26
|
44
|
|
Overall Study
NOT COMPLETED
|
20
|
3
|
Reasons for withdrawal
| Measure |
Resourcefulness Training Intervention
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
|
Attention Control
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
|
Overall Study
Protocol Violation
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
0
|
Baseline Characteristics
Resourcefulness Intervention With Parents of Technology-Dependent Children
Baseline characteristics by cohort
| Measure |
Resourcefulness Training Intervention
n=46 Participants
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
|
Attention Control
n=47 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
90 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Age, Continuous
|
39.5 Years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
38.7 Years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
39.1 Years
STANDARD_DEVIATION 10.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=99 Participants
|
47 participants
n=107 Participants
|
93 participants
n=206 Participants
|
|
General Physical Health
|
51.32 units on a scale
n=99 Participants
|
49.48 units on a scale
n=107 Participants
|
50.4 units on a scale
n=206 Participants
|
|
General Mental Health
|
42.6 units on a scale
n=99 Participants
|
42.45 units on a scale
n=107 Participants
|
42.5 units on a scale
n=206 Participants
|
|
Center for Epidemiological Studies- Depression
|
19 units on a scale
n=99 Participants
|
18.04 units on a scale
n=107 Participants
|
18.5 units on a scale
n=206 Participants
|
|
Resourcefulness Scale
|
84.96 Score on a scale
n=99 Participants
|
87.52 Score on a scale
n=107 Participants
|
86.24 Score on a scale
n=206 Participants
|
|
Depressive Cognitions Scale
|
7.7 units on a scale
n=99 Participants
|
8.4 units on a scale
n=107 Participants
|
8.03 units on a scale
n=206 Participants
|
|
Feetham Family Functioning Survey
|
43.63 units on a scale
STANDARD_DEVIATION 29.39 • n=99 Participants
|
39.57 units on a scale
STANDARD_DEVIATION 24.91 • n=107 Participants
|
41.58 units on a scale
STANDARD_DEVIATION 27.14 • n=206 Participants
|
|
Zarit Burden Scale
|
20.1 units on a scale
n=99 Participants
|
19.9 units on a scale
n=107 Participants
|
20 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: From baseline to 6 weeks, 3 months, and 6 months post-enrollmentSubjective measure of participant depressive cognitions- precursor of depressive symptoms. Score range for the instrument is 0-40, where a higher score indicates greater depressive cognition.
Outcome measures
| Measure |
Resourcefulness Training Intervention
n=46 Participants
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
|
Attention Control
n=47 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
|
|---|---|---|
|
Depressive Cognitions Scale
6 Weeks Post Enrollment Timepoint
|
6.46 Score on a Scale
Interval 0.0 to 21.0
|
6.97 Score on a Scale
Interval 0.0 to 26.0
|
|
Depressive Cognitions Scale
3 Months Post Enrollment Timepoint
|
6.32 Score on a Scale
Interval 0.0 to 23.0
|
7.28 Score on a Scale
Interval 0.0 to 32.0
|
|
Depressive Cognitions Scale
6 Months Post Enrollment Timepoint
|
5.65 Score on a Scale
Interval 0.0 to 23.0
|
7.93 Score on a Scale
Interval 0.0 to 40.0
|
PRIMARY outcome
Timeframe: From baseline to 6 weeks, 3 months, and 6 months post-enrollmentChange in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.
Outcome measures
| Measure |
Resourcefulness Training Intervention
n=46 Participants
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
|
Attention Control
n=47 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
|
|---|---|---|
|
Medical Outcomes Short Form Health Survey (SF-12) Physical Health
6 Weeks Post Enrollement Timepoint 2
|
52.7 Score on a Scale
Interval 27.0 to 64.74
|
50.77 Score on a Scale
Interval 28.26 to 66.51
|
|
Medical Outcomes Short Form Health Survey (SF-12) Physical Health
3 Months Post Enrollment Timepoint 3
|
54.49 Score on a Scale
Interval 28.39 to 67.02
|
49.46 Score on a Scale
Interval 23.19 to 65.04
|
|
Medical Outcomes Short Form Health Survey (SF-12) Physical Health
6 Months Post Enrollment Timepoint 4
|
51.49 Score on a Scale
Interval 24.78 to 64.96
|
49.81 Score on a Scale
Interval 24.43 to 62.29
|
PRIMARY outcome
Timeframe: From baseline to 6 weeks, 3 months, and 6 months post-enrollmentChange in General Mental and Physical Health from Baseline to 6 Months Post Enrollment. Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.
Outcome measures
| Measure |
Resourcefulness Training Intervention
n=46 Participants
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
|
Attention Control
n=47 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
|
|---|---|---|
|
Medical Outcomes Short Form Health Survey (SF-12) Mental Health
6 Weeks Post-Enrollment, Timepoint 2
|
47.02 Score on a Scale
Interval 22.17 to 63.97
|
45.69 Score on a Scale
Interval 17.8 to 61.42
|
|
Medical Outcomes Short Form Health Survey (SF-12) Mental Health
3 Months Post-Enrollment, Timepoint 3
|
45.54 Score on a Scale
Interval 26.17 to 63.5
|
47.41 Score on a Scale
Interval 28.67 to 64.47
|
|
Medical Outcomes Short Form Health Survey (SF-12) Mental Health
6 Weeks Post-Enrollment, Timepoint 4
|
49.51 Score on a Scale
Interval 26.17 to 63.89
|
46.79 Score on a Scale
Interval 15.15 to 62.05
|
SECONDARY outcome
Timeframe: From baseline to 6 weeks, 3 months, and 6 months post-enrollmentChange in Family Functioning from Baseline to 6 Months Post Enrollment. This subjective measure of family functioning is collected via participant survey. The score range is 0-175, which is the sum of the "differences" between reality and life expectations. Higher 'Difference' score indicates an imbalance between reality and life expectations
Outcome measures
| Measure |
Resourcefulness Training Intervention
n=46 Participants
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
|
Attention Control
n=47 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
|
|---|---|---|
|
Feetham Family Functioning Survey
6 Weeks Post Enrollment Timepoint
|
34.96 Score on a Scale
Standard Deviation 22.01
|
36.38 Score on a Scale
Standard Deviation 22.32
|
|
Feetham Family Functioning Survey
3 Months Post Enrollment Timepoint
|
39.26 Score on a Scale
Standard Deviation 22.83
|
37.44 Score on a Scale
Standard Deviation 24.32
|
|
Feetham Family Functioning Survey
6 Months Post Enrollment Timepoint
|
38.30 Score on a Scale
Standard Deviation 23.66
|
32.43 Score on a Scale
Standard Deviation 19.55
|
SECONDARY outcome
Timeframe: From baseline to 6 weeks, 3 months, and 6 months post-enrollmentSubjective survey of participants' personal and social resourcefulness. Score range is 0-140, where a higher score indicates greater resourcefulness.
Outcome measures
| Measure |
Resourcefulness Training Intervention
n=46 Participants
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
Resourcefulness Training: Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
|
Attention Control
n=47 Participants
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
|
|---|---|---|
|
Resourcefulness Scale
3 Months Post Enrollment Timepoint
|
87.47 Score on a Scale
Interval 60.0 to 102.0
|
88.22 Score on a Scale
Interval 40.0 to 125.0
|
|
Resourcefulness Scale
6 Weeks Post Enrollment Timepoint
|
86.12 Score on a Scale
Interval 50.0 to 125.0
|
93.59 Score on a Scale
Interval 58.0 to 118.0
|
|
Resourcefulness Scale
6 Months Post Enrollment Timepoint
|
89.17 Score on a Scale
Interval 22.0 to 121.0
|
93.59 Score on a Scale
Interval 58.0 to 118.0
|
Adverse Events
Resourcefulness Training Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Attention Control
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
Valerie Boebel Toly, PhD, RN, CPNP
Case Western Reserve University
Phone: (216) 368-3082
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place