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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1719 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2024-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Parents in Transition - a Nurse-led Support and Transfer Education Program

NCT04969328

Chronic Illness

ACTIVE_NOT_RECRUITING NA

Young Parents Program, Project Connect

NCT01379924

Adolescents 18 and Under When Child Was Born for Mothers 25 and Under When Child Was Born for Fathers

COMPLETED NA

Self-helpinterventions for Parenting Couples With Couple Distress.

NCT07125118

Marital Conflict

RECRUITING NA

FamilieTrivsel i Almen Praksis: a Mentalisation Programme for Families With Young Children

NCT04129359

Parent-Child Relations Child Development Parenting

UNKNOWN NA

Trial of Transition to Parenthood Program for Couples

NCT01907412

Parent-Child Relations

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

First-time Pregnant Women and Their Partners

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Family Startup

Family Startup plus usual pre- and postnatal care

Group Type EXPERIMENTAL

Family Startup (in Danish: Familieiværksætterne)

Intervention Type OTHER

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

Control

Usual pre- and postnatal care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Family Startup (in Danish: Familieiværksætterne)

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No