Trial Outcomes & Findings for Development, Feasibility and Acceptability of Fathers and Babies (FAB): A Pilot Study (NCT NCT03427528)
NCT ID: NCT03427528
Last Updated: 2022-07-18
Results Overview
Beck Depression Inventory-II (BDI-II) (Beck et al., 1988). The BDI-II was used to assess severity of depressive symptoms consistent with DSM-IV symptom criteria. The BDI-II is a 21-item survey, each item asks respondents to indicate on a scale ranging from 0 to 3 the extent to which they endorse different symptoms of depression over the past two weeks with higher scores indicating greater depression severity, with the highest score of 63. 0-10-considered normal 11-16 Mild mood disturbance 17-20 Borderline clinical depression 21-30 Moderate depression 31-40 Severe depression Over 40 Extreme depression.
COMPLETED
NA
60 participants
Baseline and Post Intervention at 3 and 6 months
2022-07-18
Participant Flow
We used a single group longitudinal pre-post design to evaluate study outcomes. Nine HV programs served as project partners and referral sites. These HV programs had been previously trained on MB and had prior experience delivering MB to perinatal women. HV programs participated in a training webinar with study investigators to review FAB implementation, study design and participant recruitment. We received 37 father-mother dyad referrals, of whom 30 (81%) were enrolled.
Participant milestones
| Measure |
FAB Pilot Study (Father Participants)
Dyads including the home visiting client (Mom) and her partner (Father) will receive separate interventions. The inventions are complimentary and were implemented in parallel.
Fathers received Fathers and Babies (FAB Intervention) while his partner (Mom) will receive MB 1-on-1 plus MB-TXT.
|
MB 1-on-1 Plus TEXT (Mother Participants)
Dyads including the HV client (Mom) and her partner (Father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
HV clients (Mothers) received the Mothers and Babies with -Text Messages intervention (i.e., MB 1-on-1 plus MB-TXT) while her partner (Father) received FAB.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
17
|
23
|
|
Overall Study
NOT COMPLETED
|
13
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development, Feasibility and Acceptability of Fathers and Babies (FAB): A Pilot Study
Baseline characteristics by cohort
| Measure |
FAB Pilot Study (Father Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
MB 1-on-1 Plus TEXT (Mother Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.7 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
26.5 years
STANDARD_DEVIATION 5.5 • n=7 Participants
|
27.1 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Educational Attainment
< High school degree
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Educational Attainment
High school degree/GED
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Educational Attainment
Some college or beyond
|
15 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Relationship Status
Married
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Relationship Status
Engaged
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Relationship Status
Single
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Relationship Status
Living with partner, not married/engaged
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Employment Status (N, %)
Not currently working
|
0 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Employment Status (N, %)
Working part-time
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Employment Status (N, %)
Working full-time
|
25 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Prenatal enrollees
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Postnatal enrollees
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Post Intervention at 3 and 6 monthsPopulation: Analysis included participants who completed assessments at all time points associated with an analysis.
Beck Depression Inventory-II (BDI-II) (Beck et al., 1988). The BDI-II was used to assess severity of depressive symptoms consistent with DSM-IV symptom criteria. The BDI-II is a 21-item survey, each item asks respondents to indicate on a scale ranging from 0 to 3 the extent to which they endorse different symptoms of depression over the past two weeks with higher scores indicating greater depression severity, with the highest score of 63. 0-10-considered normal 11-16 Mild mood disturbance 17-20 Borderline clinical depression 21-30 Moderate depression 31-40 Severe depression Over 40 Extreme depression.
Outcome measures
| Measure |
FAB Pilot Study (Father Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
MB 1-on-1 Plus TEXT (Mother Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
|---|---|---|
|
Change in Depressive Symptoms
3 Months
|
4.5 score on a scale
Standard Deviation 4.6
|
8.4 score on a scale
Standard Deviation 9.5
|
|
Change in Depressive Symptoms
6 Months
|
3.6 score on a scale
Standard Deviation 5.1
|
8.3 score on a scale
Standard Deviation 8.4
|
|
Change in Depressive Symptoms
Baseline
|
6.5 score on a scale
Standard Deviation 6.6
|
9.7 score on a scale
Standard Deviation 8.1
|
PRIMARY outcome
Timeframe: Baseline and Post Intervention at 3 and 6 monthsPopulation: Analysis was limited to individuals for whom we had complete data at the time points used for analysis.
Generalized Anxiety Disorder 7-item Scale (GAD-7) (Spitzer et al., 2006). The GAD-7 is a 7-item survey, each item asks respondents to indicate on a 4-point scale the extent to which they endorse different symptoms of anxiety over the past two weeks with higher scores indicating greater anxiety symptoms. The highest score is 21. Score 0-4: Minimal Anxiety Score 5-9: Mild Anxiety Score 10-14: Moderate Anxiety Score greater than 15: Severe Anxiety
Outcome measures
| Measure |
FAB Pilot Study (Father Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
MB 1-on-1 Plus TEXT (Mother Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
|---|---|---|
|
Change in Anxiety
Baseline
|
4.1 score on a scale
Standard Deviation 4.5
|
6.8 score on a scale
Standard Deviation 5.5
|
|
Change in Anxiety
3 Months
|
3.2 score on a scale
Standard Deviation 3.4
|
6.2 score on a scale
Standard Deviation 51
|
|
Change in Anxiety
6 Months
|
2.8 score on a scale
Standard Deviation 3.2
|
6.3 score on a scale
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: Baseline and Post Intervention at 3 and 6 monthsPopulation: Analysis was limited to individuals for whom we had complete data at the time points used for analysis.
Perceived Stress Scale 10-item Scale (PSS-10) (Cohen \& Williamson, 1988). The PSS-10 is a 10-item survey that asks respondents to indicate on a 5-point scale the extent to which they appraised certain situations as stressful over the past month, with higher scores indicating greater perceived stress. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. 0-13 are considered low stress Scores ranging from 14-26 are considered moderate stress Scores ranging from 27-40 are considered high perceived stress
Outcome measures
| Measure |
FAB Pilot Study (Father Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
MB 1-on-1 Plus TEXT (Mother Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
|---|---|---|
|
Change in Perceived Stress
3-Month
|
12.6 score on a scale
Standard Deviation 7.1
|
16.9 score on a scale
Standard Deviation 7.4
|
|
Change in Perceived Stress
Baseline
|
14.9 score on a scale
Standard Deviation 7.6
|
20.4 score on a scale
Standard Deviation 9.1
|
|
Change in Perceived Stress
6-Month
|
10.9 score on a scale
Standard Deviation 9.1
|
16.8 score on a scale
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline and Post Intervention at 3 and 6 monthsPopulation: Analysis was limited to individuals for whom we had complete data at the time points used for analysis.
Social Support Effectiveness Questionnaire (SSE-Q) (Rini et al., 2011). The SSE-Q is a 25-item survey that asks respondents to indicate the extent to which their partners provided different types of support in the past three months. The SSE-Q consists of subscales on task support, informational support, emotional support, and negative effects of support. For this study, we calculated a total social support score that summed these four subscales (range 0-80). High scores indicate more effective support. Full scale scores can range from 0 to 80, and each subscale can range from 0 to 20.
Outcome measures
| Measure |
FAB Pilot Study (Father Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
MB 1-on-1 Plus TEXT (Mother Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
|---|---|---|
|
Change in Social Support Effectiveness
Baseline
|
60.9 score on a scale
Standard Deviation 14.3
|
48.9 score on a scale
Standard Deviation 11.6
|
|
Change in Social Support Effectiveness
3-Month
|
57.8 score on a scale
Standard Deviation 12.6
|
51.4 score on a scale
Standard Deviation 14.5
|
|
Change in Social Support Effectiveness
6-Month
|
59.3 score on a scale
Standard Deviation 13.7
|
52.2 score on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Baseline and Post Intervention at 3 and 6 monthsPopulation: Analysis was limited to individuals for whom we had complete data at the time points used for analysis.
The measure consists of 8 questions and asks respondents to indicate on a 5-point scale the extent to which they have received different types of instrumental support in the last month. Higher scores indicate greater support. We report on the count and percentage of individuals with high instrumental support at each time point.
Outcome measures
| Measure |
FAB Pilot Study (Father Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
MB 1-on-1 Plus TEXT (Mother Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
|---|---|---|
|
Instrumental Social Support Support Survey (Cyranowski et al., 2013).
Baseline
|
9 Participants
|
4 Participants
|
|
Instrumental Social Support Support Survey (Cyranowski et al., 2013).
3-Month
|
6 Participants
|
8 Participants
|
|
Instrumental Social Support Support Survey (Cyranowski et al., 2013).
6-Month
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline and Post Intervention at 3 and 6 monthsPopulation: NIH Toolbox Instrumental Support Support Survey. Each survey consists of 8 questions and asks respondents to indicate on a 5-point scale the extent to which they have received different types of instrumental and emotional support in the last month. Higher scores indicate greater support. Reported on percentage of participants with high levels of instrumental support at all time points.
NIH Toolbox Emotional Support Support Survey. The survey consists of 8 questions and asks respondents to indicate on a 5-point scale the extent to which they have received different types of emotional support in the last month. Higher scores indicate greater support. We report on the count and percentage of individuals with high emotional support at each time point.
Outcome measures
| Measure |
FAB Pilot Study (Father Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
MB 1-on-1 Plus TEXT (Mother Participants)
n=30 Participants
Dyads including a HV client (mother) and her partner (father) will receive separate interventions. The inventions are complimentary and will be implemented in parallel.
|
|---|---|---|
|
Emotional Support Support (Cyranowski et al., 2013)
Baseline
|
9 Participants
|
7 Participants
|
|
Emotional Support Support (Cyranowski et al., 2013)
3-Month
|
6 Participants
|
9 Participants
|
|
Emotional Support Support (Cyranowski et al., 2013)
6-Month
|
8 Participants
|
5 Participants
|
Adverse Events
FAB Pilot Study (Father Participants)
MB 1-on-1 Plus TEXT (Mother Participants)
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