- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05063448
DadSpace: Increasing Community Support Resources for Perinatal Fathers
February 23, 2023 updated by: Julie Rieker, Colorado State University
The project is aimed at meeting the support needs of community fathers who are expecting a baby or who have recently had a baby.
This work is being conducted in conjunction with community partners through The Women's Clinic of Northern Colorado (WCNC).
Researchers and WCNC staff will work together to develop and implement programs for prenatal and postpartum fathers.
Participants will be invited to a group mentoring program and also will be provided access to supplementary educational podcasts focused on topics relevant to prenatal and postpartum fathers.
The investigators are seeking to understand what participants like and don't like about the program and how participation in the program affects participants' stress, well-being, and parenting.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
The investigators are building on previous work to identify opportunities to meet the needs of perinatal fathers.
The term perinatal encompasses the time leading up to and immediately following the birth of a child.
Father involvement in child rearing is beneficial to mothers and children, but fathers are routinely overlooked by available support opportunities at the transition to parenthood.
This pilot project seeks to apply research evidence and best practices to address the disparity in socioemotional community support and education programs serving perinatal fathers.
In a previous pilot study, the investigators learned from fathers participating in focus groups that participants were interested in opportunities to connect with other fathers in the same life stage to talk about personal experiences and learn from each other.
The investigators also learned that fathers worry about meeting varied role expectations, that available resources tend to overlook the unique experiences of fathers, and that it can be challenging to find quality information in a digital world saturated with conflicting information about parenting.
This project seeks to address these primary issues through community-based, father-centric support and educational programs.
WCNC education staff will facilitate a discussion-based group mentoring program for fathers who are expecting or recently had a baby.
This program seeks to increase connection with other fathers, reduce stress related to parenting a baby, and increase parenting confidence.
The investigators plan to evaluate the feasibility of the program through satisfaction surveys and other measures of the program's implementation.
The investigators also plan to evaluate the effectiveness of the program by providing participants with surveys asking about their well-being, knowledge, confidence in parenting, and their satisfaction with their social networks.
The investigators are additionally developing educational podcasts focused on topics relevant to prenatal and postpartum fathers, which will be evaluated as a supplementary component to the mentoring program.
Research objectives are the following: Study 1, Objective 1 (Primary): The investigators seek to determine the feasibility and acceptability of a program targeting perinatal fathers offered in a community clinic setting.
Study 1, Objective 2 (Primary): Examine whether participating in a discussion-based group mentoring program increases the likelihood of positive short-term outcomes for fathers.
Study 1 Objective 3 (Secondary): Identify whether listening to brief, targeted educational podcasts predicts increased positive outcomes for fathers over and above the mentoring group alone.
Study 2 Objective 1 (Primary): Identify whether participants who listen to brief, targeted educational podcasts find the podcasts satisfactory and acceptable as a method of gaining information about perinatal fatherhood.
Study Type
Interventional
Enrollment (Anticipated)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stephanie R Rayburn, MS
- Phone Number: 970-988-6306
- Email: Stephanie.Rayburn@colostate.edu
Study Contact Backup
- Name: Julie Braungart-Rieker, PhD
- Phone Number: 970-491-3581
- Email: JulieBraungart.Rieker@colostate.edu
Study Locations
-
-
Colorado
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Fort Collins, Colorado, United States, 80523-1570
- Colorado State University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Participants must be expecting a baby or have a baby less than one year of age and planning to take the DadSpace mentoring program.
Exclusion Criteria:
- Non-English speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DadSpace Intervention
Participants will take part in a 12-hour educational discussion-based mentoring program intervention over 8 weeks.
The intervention will be facilitated by a trained father facilitator and will include education and support on topics relevant to perinatal fathers.
Topics include father identity, stress management, infant development, co-parenting, masculinity and caregiving, healthy communication, and work-life balance.
Participants will additionally have access to a brief educational podcast series on related topics.
Participants will also be invited to monthly follow-up daddy/baby drop-in groups.
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A group educational support and mentoring program for perinatal fathers.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Self-Perceptions of the Parental Role-Competence scale
Time Frame: Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
A 6-item measure of feelings of efficacy/competence in the parental role.
Items are weighted on a range from 1 to 5, with higher scores indicating higher confidence in the parental role, a better outcome.
|
Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
Change in Social Network Questionnaire-Satisfaction scale
Time Frame: Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
7 yes/no items on satisfaction with the support received from one's social network.
More "yes" answers indicates lower satisfaction with the social network, a worse outcome.
|
Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
Change in Role Conflict scale
Time Frame: Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
3 subscales that assess work conflict with family life, family life conflict with work, and work-family balance.
Item values range from 1 to 6 for the first two subscales and 1 to 5 for the third (work-family balance) subscale.
Higher scores on the first two subscales (work interference with family life, family interference with work life) indicate a worse outcome.
Higher scores on work-family balance satisfaction indicate a better outcome.
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Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
Change in Perceived Stress Scale
Time Frame: Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
10 items related to anxiety, stress, and coping with upsets.
Items values range from 0 to 4 with higher scores indicating higher perceived stress, a worse outcome.
|
Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
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Change in Edinburgh Postnatal Depression Scale
Time Frame: Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
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10 items that measure core features of postnatal depression.
Item values range from 1 to 4 with a higher score indicating higher depressive symptoms, a worse outcome.
|
Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
Change in Spielberger State Anxiety Scale (Short Form)
Time Frame: Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
10 items assessing feelings of upset and anxiety versus contentment at the present time.
Item values range from 1 to 4 with a higher score indicating higher state anxiety, a worse outcome.
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Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
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Change in Coparenting Relationship Scale - Brief
Time Frame: Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
15 items assessing coparent collaboration versus conflict related to child rearing.
Items values range from 0 to 6 with higher scores indicating a better coparenting relationship.
|
Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
Change in Knowledge of Infant Development Inventory
Time Frame: Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
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This abbreviated version of the inventory assesses accurate knowledge (% correct) of infant development.
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Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pearlin Mastery Scale
Time Frame: Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
7-item measure of general self-efficacy versus helplessness.
Item values range from 1 to 6 with higher scores indicating worse self-efficacy.
|
Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
|
Change in Paternal Postnatal Attachment Scale
Time Frame: Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
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Assesses fathers' positive feelings versus lack of enjoyment with the baby.
Item values have been revised from the original scale to range from 1 to 6 with higher scores indicating more positive feelings toward the baby.
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Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observation of facilitator teaching
Time Frame: Randomly over the 8 weeks of intervention delivery
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Random observations of facilitator interactive teaching methods
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Randomly over the 8 weeks of intervention delivery
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Attendance
Time Frame: Measured across the 8 weeks of intervention delivery
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# of sessions attended by participants (dosage)
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Measured across the 8 weeks of intervention delivery
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Facilitator fidelity to protocol
Time Frame: Measured across the 8 weeks of intervention delivery
|
A checklist of intervention items completed by the facilitator to identify adherence to the intervention protocol.
utility--self-rated helpfulness information sources (e.g., podcasts, sessions)
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Measured across the 8 weeks of intervention delivery
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Helpfulness of information sources
Time Frame: Measured across the 8 weeks of intervention delivery
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Fathers report on how helpful they found the provided resources (e.g., podcast, information)
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Measured across the 8 weeks of intervention delivery
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Participant Engagement
Time Frame: Measured across the 8 weeks of intervention delivery
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Facilitator ratings of participants' active participation and evidence that fathers have been trying out skills covered in classes
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Measured across the 8 weeks of intervention delivery
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Home Practice (implementation evaluation)
Time Frame: At the beginning of each week of the intervention, 8 weeks during intervention delivery
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Fathers report on how many hours they devoted to homework in the previous week, how well they mastered the lessons, and how helpful was the information
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At the beginning of each week of the intervention, 8 weeks during intervention delivery
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Support Group Social Exchange Scale
Time Frame: Immediately after the intervention
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participants report on open communication among the group and emotional support.
Item values range from 0 to 6 with higher scores indicating higher social support from the group, a better outcome.
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Immediately after the intervention
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Satisfaction with DadSpace program
Time Frame: Immediately after the end of the intervention
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Fathers rate their overall satisfaction with various aspects of the program as well as the utility of each of the session.
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Immediately after the end of the intervention
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Workshop Environment Scale
Time Frame: Immediately after the end of the intervention
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A 10-item abbreviated measure of how supportive participants perceived the facilitator and group dynamics to be.
Item values range from 1 to 4 with higher values indicating a more supportive group environment.
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Immediately after the end of the intervention
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Podcast Satisfaction
Time Frame: Measured across the 8 weeks of intervention delivery
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Fathers who listen to the podcast rate how satisfied they are with the podcast topic and format
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Measured across the 8 weeks of intervention delivery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julie Braungart-Rieker, PhD, Colorado State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 6, 2021
Primary Completion (Actual)
December 31, 2022
Study Completion (Anticipated)
April 30, 2023
Study Registration Dates
First Submitted
September 8, 2021
First Submitted That Met QC Criteria
September 21, 2021
First Posted (Actual)
October 1, 2021
Study Record Updates
Last Update Posted (Estimate)
February 27, 2023
Last Update Submitted That Met QC Criteria
February 23, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1754
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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