Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05063448
Other study ID # 1754
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date August 6, 2021
Est. completion date April 30, 2023

Study information

Verified date February 2023
Source Colorado State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 19
Est. completion date April 30, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
DadSpace
A group educational support and mentoring program for perinatal fathers.

Locations

Country Name City State
United States Colorado State University Fort Collins Colorado

Sponsors (2)

Lead Sponsor Collaborator
Colorado State University Colorado Clinical & Translational Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Observation of facilitator teaching Random observations of facilitator interactive teaching methods Randomly over the 8 weeks of intervention delivery
Other Attendance # of sessions attended by participants (dosage) Measured across the 8 weeks of intervention delivery
Other Facilitator fidelity to protocol 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) Measured across the 8 weeks of intervention delivery
Other Helpfulness of information sources Fathers report on how helpful they found the provided resources (e.g., podcast, information) Measured across the 8 weeks of intervention delivery
Other Participant Engagement Facilitator ratings of participants' active participation and evidence that fathers have been trying out skills covered in classes Measured across the 8 weeks of intervention delivery
Other Home Practice (implementation evaluation) 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 At the beginning of each week of the intervention, 8 weeks during intervention delivery
Other Support Group Social Exchange Scale 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. Immediately after the intervention
Other Satisfaction with DadSpace program Fathers rate their overall satisfaction with various aspects of the program as well as the utility of each of the session. Immediately after the end of the intervention
Other Workshop Environment Scale 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. Immediately after the end of the intervention
Other Podcast Satisfaction Fathers who listen to the podcast rate how satisfied they are with the podcast topic and format Measured across the 8 weeks of intervention delivery
Primary Change in Knowledge of Infant Development Inventory This abbreviated version of the inventory assesses accurate knowledge (% correct) of infant development. Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
Primary Change in Self-Perceptions of the Parental Role-Competence scale 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
Primary Change in Social Network Questionnaire-Satisfaction scale 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
Primary Change in Role Conflict scale 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. Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
Primary Change in Perceived Stress Scale 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
Primary Change in Edinburgh Postnatal Depression Scale 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
Primary Change in Spielberger State Anxiety Scale (Short Form) 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. Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
Primary Change in Coparenting Relationship Scale - Brief 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
Secondary Change in Pearlin Mastery Scale 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
Secondary Change in Paternal Postnatal Attachment Scale 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. Every 4 weeks up to 16 weeks, including pre-intervention, mid-intervention, post-intervention, and follow-up
See also
  Status Clinical Trial Phase
Recruiting NCT04065867 - Use ICT to Promote Family Well-being in Hong Kong
Completed NCT02902003 - Testing Relationship Skills Education Services With a Robust Economic Security Component N/A
Completed NCT02792309 - Impact Evaluation of MotherWise Program N/A
Completed NCT01037946 - Family to Family: Psychoeducation to Improve Children's Outcomes in HIV+ Families N/A
Completed NCT00996541 - Support To Reunite Involve and Value Each Other N/A
Recruiting NCT05977114 - 4Rs for a Better Family N/A
Completed NCT04257331 - Parent Training to Reduce Behavioral Problems in Children With Autism Spectrum Disorder in China N/A
Completed NCT03487796 - MySTYLE: Online Family-based HIV Prevention for Non-heterosexual Black Adolescent Males in the South N/A
Recruiting NCT05172297 - Internet-based Universal Parent Training as a Booster to PATHS®: Parent Web N/A
Completed NCT03127579 - Family Meal Duration and Children's Eating Behavior N/A
Recruiting NCT04362475 - Community Health Through Engagement and Environmental Renewal N/A
Active, not recruiting NCT04370964 - Evolution of Family Alliance in Families With a Designated Adolescent Patient (12-18 Years) During a Family Therapy Process N/A
Completed NCT03828370 - DWI Offenders and Their Families App for Smartphones N/A
Recruiting NCT03960372 - Public Education to Promote Family Communication and Well-being
Not yet recruiting NCT06275412 - Family Intervention for Black Teens With Type 1 Diabetes N/A
Recruiting NCT05275413 - mHealth Intervention to Reduce Maternal Postnatal Depression and Promote Family Health N/A
Recruiting NCT06156124 - The Role of Family and Individual Factors in Going Through Adolescence - Perspective of a Healthy Child.
Not yet recruiting NCT05477901 - Impacts of Cash Transfers on Child Neurodevelopment (Auxilio Brasil) N/A
Recruiting NCT05356247 - Lausanne Trialogue Paradigm - Brief: A Family Model for Child Mental Health in a Community Setting N/A
Recruiting NCT03872895 - Adjustment of Adopted Adolescents in Their Families