Trial · NCT07893210
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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. |
| Other | FAB Intervention Dosage (RE-AIM Framework; ADOPTION) | up to 18 weeks | To assess "adoption" descriptive statistics will be used to determine the dosage of the FAB intervention received by participants. |
| Other | Acceptability of Intervention Measure (RE-AIM Framework; IMPLEMENTATION) | 20 weeks after 1st intervention session and up to 2 years | To assess different aspects of intervention implementation, we will administer the Acceptability of Intervention Measure (AIM). The AIM is a 4-item implementation outcome measure of acceptability used to monitor and evaluate the success of implementation efforts. It is rated on a 5-point Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Total scores range from 4 to 20, with higher scores reflecting greater perceived acceptability. |
| Other | Feasibility of Intervention Measure (RE-AIM Framework; IMPLEMENTATION) | 20 weeks after 1st intervention session and up to 2 years | To assess different aspects of intervention implementation, we will administer the Feasibility of Intervention Measure (FIM). The FIM is a 4-item survey tool used in implementation science to evaluate how easily an intervention can be carried out within an organization. Each item is rated on a 5-point Likert scale ranging from completely disagree (1) to completely agree (5). Scores range from 4 to 20, with higher scores reflecting greater perceived feasibility. |
| Other | Intervention Appropriateness Measure (RE-AIM Framework; IMPLEMENTATION) | 20 weeks after 1st intervention session and up to 2 years | To assess different aspects of intervention implementation, we will administer the Intervention Appropriateness Measure (IAM). The IAM is a 4-item psychometric questionnaire used in implementation science to evaluate the perceived fit, relevance, or compatibility of an intervention within an organization. Responses are averaged to produce a composite score from 1 to 5, with higher scores reflecting greater perceived appropriateness. |
| Other | Modification and Adaptation Checklist (RE-AIM Framework; IMPLEMENTATION) | Up to 2 years | The Modification and Adaptation Checklist (MAC) measure will be used to assess home visitors' reported fidelity-consistent and fidelity-inconsistent adaptations of FAB. The MAC does not generate a single numerical score. Instead, it functions as a descriptive and categorical tracking tool (checking yes/no) |
| Other | Normalization Measure Development Questionnaire (RE-AIM Framework; MAINTENANCE) | Up to 2 years | To assess "maintenance," (the extent to which a program becomes institutionalized or part of the routine organizational practices) the Normalization Measure Development Questionnaire (NoMAD) will be used. The NoMAD is a 23-item survey tool used in implementation science to measure and monitor how a new intervention becomes embedded into routine workflows within an organization. Analysis of the NoMAD will generate an overall score averaged across respondents. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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