First-time Pregnant Women and Their PartnersFIVNCT02294968
The Family Startup Program. A Randomized Controlled Trial of a Universal Group-based Parenting Support Program
A study testing Family Startup (in Danish: Familieiværksætterne) in people with First-time Pregnant Women and Their Partners, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First-time Pregnant Women and Their Partners
- What is being tested?
- Family Startup (in Danish: Familieiværksætterne)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,719 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Being tested
- Family Startup (in Danish: Familieiværksætterne)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Startup (in Danish: Familieiværksætterne)Other
Manualized parenting support program; see Center for Socialt Ansvar (2013)
| Study group | Role | What they receive |
|---|---|---|
| Family Startup | Experimental | Family Startup plus usual pre- and postnatal care Receives: Other: Family Startup (in Danish: Familieiværksætterne) |
| Control | No intervention | Usual pre- and postnatal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Parenting Sense of Competence scale (PSOC)
Measured: measured when child is 9 months
Secondary outcomes (5)
The Parenting Sense of Competence scale (PSOC)
Measured: measured when child is 18 months
Parenting Stress Scale
Measured: measured when child is 9 months
Breastfeeding duration
Measured: Duration before child is 9 months
Couple Satisfaction Index
Measured: measured when child is 9 months
Coparenting Relationship Scale
Measured: measured when child is 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2018
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for First-time Pregnant Women and Their PartnersStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,719 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Aarhus Kommune, TrygFonden, Denmark
- Responsible party
- Sponsor
- Investigators
- Marianne Simonsen, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294968
- Sponsor's protocol ID
- FIV1
- Acronym
- FIV
- Status last verified
- May 2022
- First submitted
- 14 Nov 2014
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34509031Trillingsgaard 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.
PubMed 25895494
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Family Startup Program. A Randomized Controlled Trial of a Universal Group-based Parenting Support Program
- ClinicalTrials.gov ID
- NCT02294968
- Acronym / sponsor ID
- FIV / FIV1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,719 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital Skejby, Aarhus Kommune, TrygFonden, Denmark
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Feb 2024 (estimated)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Startup | Experimental | Other: Family Startup (in Danish: Familieiværksætterne)Family Startup plus usual pre- and postnatal care |
| Control | No intervention | –Usual pre- and postnatal care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Startup (in Danish: Familieiværksætterne)Manualized parenting support program; see Center for Socialt Ansvar (2013) | Other | Family Startup |
Primary outcome
The Parenting Sense of Competence scale (PSOC)
Time frame: measured when child is 9 months
5 secondary outcomes
The Parenting Sense of Competence scale (PSOC)
Time frame: measured when child is 18 months
Parenting Stress Scale
Time frame: measured when child is 9 months
Breastfeeding duration
Time frame: Duration before child is 9 months
Couple Satisfaction Index
Time frame: measured when child is 9 months
Coparenting Relationship Scale
Time frame: measured when child is 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Derived from this study: PubMed 34509031Trillingsgaard 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.
- Derived from this study: PubMed 25895494Trillingsgaard 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Simonsen, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Startup (in Danish: Familieiværksætterne) in people with First-time Pregnant Women and Their Partners, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Parenting Sense of Competence scale (PSOC) (time frame: measured when child is 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02294968, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.