Trial · NCT07893210
Fathers and Babies (FAB) Research Study
NCT07893210, Not applicable, Recruiting, Northwestern University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fathers and Babies (FAB) Research Study. Trials, record NCT07893210. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07893210
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fathers and Babies (FAB) Research Study
- NCT number
- NCT07893210
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 624 participants, estimated
- Lead sponsor
- Northwestern University
- Conditions
- Perinatal Mental Health, Fathers, Stress Management
- Interventions
- Fathers and Babies Program, Mothers and Babies Program
- First posted
- 2026-10-23
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mental Health Outcomes: Stress | All father and mother participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB or FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants). | The Perceived Stress Scale will be used to assess perceived stress in father and mother participants. assigning values from 0 to 4 to each of its 10 questions ("Never" = 0, "Almost never" = 1, "Sometimes" = 2, "Fairly often" = 3, "Very often" = 4). Reverse scoring is applied to the four positive items (items 4, 5, 7, and 8) where 0=4, 1=3, 2=2, 3=1, and 4=0. All scores are then summed. Scores between 14-26 indicate moderate stress. Scores between 27-40 indicate high perceived stress. |
| Primary | Mental Health Outcome: Depression | All father and mother participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB or FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants). | The Edinburgh Postpartum Depression Scale will be used to assess depression symptoms. The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire scored from 0 to 30. Questions 1, 2, and 4 score 0 to 3 sequentially, while questions 3 and 5-10 are reverse-scored (3 to 0). A total score of 13 flags a possible depressive risk requiring clinical evaluation, and any positive response to question 10 regarding self-harm requires immediate safety assessment. |
| Primary | Mental Health Outcome: Anxiety | All father and mother participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB or FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants). | The Generalized Anxiety Disorder Scale will be used to assess anxiety symptoms. The GAD-7 (Generalized Anxiety Disorder-7) is a seven-question tool used to measure anxiety severity. Each question is scored from 0 to 3 based on how often symptoms occurred over the past two weeks. A score of 10 or higher suggests probable clinical anxiety. |
| Secondary | Mental Health Outcome: Mood Regulation | All father participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB or FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants). | The Negative Mood Regulation Scale will be used to asses mood regulation. The Negative Mood Regulation (NMR) Scale is a 30-item questionnaire measuring a person's belief that their actions or thoughts will help change a negative mood. Total scores range from 30 to 150, calculated by summing all item responses on a 5-point Likert scale. Higher scores mean stronger confidence in managing negative moods. |
| Secondary | Mental Health Outcomes: Behavioral Activation Depression Scale | All father participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB and FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants). | The Behavioral Activation for Depression Scale (BADS) is a 25-item self-report instrument scored on a 7-point Likert scale from 0 ("not at all") to 6 ("completely"). It uses four subscales (Activation, Avoidance/Rumination, Work/School Impairment, Social Impairment) where subscale items are summed directly, and a total score is computed by reverse-scoring the avoidance and impairment subscales. Higher total scores reflect healthier behavioral activation and less overall depressive disengagement. |
| Secondary | Parenting Outcome: The Fatherhood Research and Practice Network (FRPN) Father Engagement Scale | All father participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB and FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants). | The Fatherhood Research and Practice Network (FRPN) Father Engagement Scale is a free, validated research tool designed to assess the frequency of a father's involvement and engagement with his children. The scale is divided into four distinct age-based versions. This study will use version 1 and 2 (version 1: children 1 month to 1 year old; version 2: children 1 year, 1 month to 6 years old). |
| Secondary | Relationship Satisfaction: Revised Dyadic Adjustment Scale | All father and mother participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB and FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants). | The Revised Dyadic Adjustment Scale (RDAS) is a 14-item questionnaire scored by summing all item values to yield a total score from 0 to 69. Higher scores mean better relationship adjustment, while a total score of 48 or less indicates relationship distress. |
| Secondary | Social Support: Social Support Effectiveness Survey | All father and mother participants will complete this measure at baseline, 20 and 32 weeks after completing the 1st FAB and FAB with MB session (if intervention randomized) or at baseline, 20 and 32 weeks after study enrollment (if control participants). | The Social Support Effectiveness Questionnaire (SSE-Q), yields full-scale scores ranging from 0 to 80, with each subscale ranging from 0 to 20. Higher scores reflect more effective and adaptive social support. |
| Other | HVs trained in FAB that delivered FAB (RE-AIM Framework; REACH) | 12 months post-training | Percentage of home visitors trained in FAB who begin implementing the intervention |
| Other | Fathers' Enrollment (RE-AIM Framework; REACH) | Up to 2 years | The percentage of clients meeting FAB eligibility criteria that enroll in the study. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07893210
GET https://conductscience.org/api/trials/v1/NCT07893210/registered