The Family Startup Program. A Randomized Controlled Trial of a Universal Group-based Parenting Support Program

First-time Pregnant Women and Their Partners Clinical Trial

— FIV  

Official title:

The Family Startup Program. A Randomized Controlled Trial of a Universal Group-based Parenting Support Program

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02294968
• Other study ID #: FIV1
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: February 2024

Study information

• Verified date: May 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of this study are to determine whether a group-based parent support program ("Family Startup") can lead to early improved parental sense of competence, family relations, and child development. Evaluation is based on a randomized controlled trial, with half of the participants receiving Family Startup and the other half receiving treatment as usual.

Description:

Some knowledge exists about effectiveness of high-intensity delivery of parenting support to subsets of at risk families. To the best of our knowledge, however, little is known about effects of universal primary prevention programs.

The Family Startup Program is a structured format for implementing pre- and postnatal parenting support groups that prepare new families for their roles as parents as well as focus on enhancing parents' social network. The Family Startup Program gathers couples in groups and introduces participants to informal sources of support (e.g. by meeting and interacting with other new families) and to a broad range of community resources (e.g. financial advisers, child dentist, local solicitors, family counselors) providing them with information and parenting skills. The program content includes handling family finance, choice of paternity leave, couple communication, breastfeeding, network formation, ensuring dental health, sensitivity toward child signals, child rearing discipline, help-seeking behavior, home safety, and more.

A second formulated rational behind the program is that strengthening father involvement, social network formation and access to family services will serve to enhance family relationships, including parenting, coparenting and couple relationship quality. Through participation in Family Startup, families receive a long term connection with a health visitor in the community and are introduced to a broad range of community services. This can be expected to benefit optimal health service utility and ease access to resources for families and children with need. Improved child outcome are the ultimate goal. No scientific evaluation of program effects of the Family Startup program on child or family outcome was previously conducted.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1719
• Est. completion date: February 2024
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

-Parents, mothers as well as their partners, expecting their first child in the municipality of Aarhus are eligible for the study. This is because of the universal nature of the original program. Mothers are included if interested regardless of the fathers' decline. Biological fathers, registered partners, as well as non-registered partners are eligible.

Exclusion Criteria:

• Parents are excluded from the study if they are under the age of 18 years

• Not capable of managing own legal affairs

• Choose not to accept any routine pregnancy scans. These exclusion criteria are chosen to secure that study participants are legally responsible and that we are able to recruit them via the Department of Obstetrics and Gynaecology in connection with the nuchal translucency scan around week 12

• The father or partner is not included if the mother declines participation. The mother can choose to attend the Family Startup Program with a friend (i.e. a sister, friend or neighbor) but friends are not eligible for the study

• Finally, individuals are excluded if they are not able to understand the Danish oral presentation of the study information and hence cannot give informed consent

Related Conditions & MeSH terms

• First-time Pregnant Women and Their Partners

Intervention

Other:
• Family Startup (in Danish: Familieiværksætterne)
Manualized parenting support program; see Center for Socialt Ansvar (2013)

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby	Aarhus N

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus Kommune, Aarhus University Hospital Skejby, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of visits to the general practitioner		measured when child is 9 months
Other	Ages and Stages Questionnaire		measured when child is 9 months
Other	School starting age		Before child is 8 years old
Primary	The Parenting Sense of Competence scale (PSOC)		measured when child is 9 months
Secondary	The Parenting Sense of Competence scale (PSOC)		measured when child is 18 months
Secondary	Parenting Stress Scale		measured when child is 9 months
Secondary	Breastfeeding duration		Duration before child is 9 months
Secondary	Couple Satisfaction Index		measured when child is 9 months
Secondary	Coparenting Relationship Scale		measured when child is 9 months