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

NCT02294968 | Unknown DMC

• 1 other identifier: FIV1
• Study Type: interventional
• Target: 1,719
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

First-time Pregnant Women and Their Partners

Outcome Measures

Primary Outcomes (1)

• The Parenting Sense of Competence scale (PSOC)

  measured when child is 9 months

Secondary Outcomes (5)

• The Parenting Sense of Competence scale (PSOC)

  measured when child is 18 months

• Parenting Stress Scale

  measured when child is 9 months

• Breastfeeding duration

  Duration before child is 9 months

• Couple Satisfaction Index

  measured when child is 9 months

• Coparenting Relationship Scale

  measured when child is 9 months

Other Outcomes (3)

• number of visits to the general practitioner

  measured when child is 9 months

• Ages and Stages Questionnaire

  measured when child is 9 months

• School starting age

  Before child is 8 years old

Study Arms (2)

Family Startup

EXPERIMENTAL

Family Startup plus usual pre- and postnatal care

Other: Family Startup (in Danish: Familieiværksætterne)

Control

NO INTERVENTION

Usual pre- and postnatal care

Interventions

Family Startup (in Danish: Familieiværksætterne) OTHER

Manualized parenting support program; see Center for Socialt Ansvar (2013)

Family Startup

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Parents are excluded from the study if they are under the age of 18 years
• Not capable of managing own legal affairs
• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital Skejby: collaborator
• Aarhus Kommune: collaborator
• TrygFonden, Denmark: collaborator

Study Sites (1)

Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

Related Publications (2)

• Trillingsgaard TL, Maimburg RD, Simonsen M. Group-based parent support during the transition to parenthood: Primary outcomes from a randomised controlled trial. Soc Sci Med. 2021 Oct;287:114340. doi: 10.1016/j.socscimed.2021.114340. Epub 2021 Aug 30.

  PMID: 34509031 DERIVED

• Trillingsgaard T, Maimburg RD, Simonsen M. The Family Startup Program: study protocol for a randomized controlled trial of a universal group-based parenting support program. BMC Public Health. 2015 Apr 21;15:409. doi: 10.1186/s12889-015-1732-3.

  PMID: 25895494 DERIVED

Study Officials

• Marianne Simonsen, PhD

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 19, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: February 1, 2024
• Last Updated: May 31, 2022

Record last verified: 2022-05

Locations

DK (1)