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

University of Aarhus logo

University of Aarhus

Status

Unknown

Conditions

First-time Pregnant Women and Their Partners

Treatments

Other: Family Startup (in Danish: Familieiværksætterne)

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,719 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,719 participants in 2 patient groups

Family Startup
Experimental group
Description:
Family Startup plus usual pre- and postnatal care
Treatment:
Other: Family Startup (in Danish: Familieiværksætterne)
Control
No Intervention group
Description:
Usual pre- and postnatal care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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