Pilot Trial of Family Partner - a Child Maltreatment Prevention Intervention

NCT ID: NCT04957394

Last Updated: 2025-08-11

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

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-09-18

Brief Summary

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

Prior to this pilot study, it is unclear whether comparing a manualized version of the Family Partner Model to standard practice in the Child Welfare Services would be feasible. Results will inform whether and how to design a fully powered randomized controlled trial to test the effects of a manualized version of the Family Partner Model on child maltreatment. The specific results of the pilot study will inform 1) randomization procedures, 2) data sources to be used, 3) sample size calculations, and 4) adaptations to the design and measures for a fully powered randomized controlled trial.

Detailed Description

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

The objective is to assess the adaptability and acceptability of the Family Partner Intervention, and the feasibility of a future randomised controlled trial. Our specific research questions are:

1. What is the adaptability, acceptability, and feasibility of the Family Partner intervention in a Norwegian municipal context?
2. What are the experiences and possible outcomes of the Family Partner intervention?
3. Is the trial design feasible for an RCT expansion?

The investigators will pilot a parallel randomized trial (RCT), allocated to two groups (treatment and control). Families that fit to the target group, will be invited to take part in the study. Each family which fit the inclusion criteria and consent to participate will be randomized with a 1:1 allocation to experimental and control groups. Each Family Partner can serve 5 families at a time, and the Family Partner will serve families from 6-18 months. As families complete the programme, new families will be recruited. Hence, the recruitment and randomization will be an ongoing process. Any changes to methods after pilot trial commencement will be reported along with study results.

In a future RCT, the objective is to evaluate the effectiveness of the Family Partner Intervention, i.e. whether introducing the intervention would improve the outcome of existing Child Welfare Services. Hence, the trial is a superiority trial, in which the Family Partner Intervention is hypothesized to be superior to existing service provision. The trial is designed according to an intention-to-treat principle, where all consented participants are included in the analyses, independent of their adherence to intervention.

Conditions

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

Family Parenting Child Maltreatment

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

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

Experimental (Family Partner)

The treatment group will receive six hours follow-up and support weekly. The service will be provided by a dedicated Family Partner.

Group Type EXPERIMENTAL

Family Partner

Intervention Type BEHAVIORAL

The Family Partner intervention is based on well-known elements for preventing child abuse and neglect, such as 1) high intensity intervention with home visitations, 2) coordination of services, 3) an ecological perspective, 4) parental guidance, and 5) an emphasis on a therapeutic relationship with parents to create trust, change and agency.

Family Partners must have relevant professional background and education, such as social work, child welfare services and other health/welfare occupations. They must have a personal attitude for relation-based service delivery in a home-setting, a long work experience and in-depth knowledge of municipal welfare services.

Each practitioner will follow five families. The estimated duration of the intervention is 12 months, but might go over longer stretches of time if it is considered beneficial for the families. The minimum duration of the intervention is 3 months.

Control group

The control group will receive default support from the child welfare services. The service will be "business as usual", provided by the local staff at the child welfare services.

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 Partner

The Family Partner intervention is based on well-known elements for preventing child abuse and neglect, such as 1) high intensity intervention with home visitations, 2) coordination of services, 3) an ecological perspective, 4) parental guidance, and 5) an emphasis on a therapeutic relationship with parents to create trust, change and agency.

Family Partners must have relevant professional background and education, such as social work, child welfare services and other health/welfare occupations. They must have a personal attitude for relation-based service delivery in a home-setting, a long work experience and in-depth knowledge of municipal welfare services.

Each practitioner will follow five families. The estimated duration of the intervention is 12 months, but might go over longer stretches of time if it is considered beneficial for the families. The minimum duration of the intervention is 3 months.

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* parents are 18 years or older, and
* children are under 18 years, and
* families with complex challenges who are already involved in the Child Welfare Services, and
* children live under potentially harmful circumstances, and
* parents struggle in several areas, e.g. employment, poverty, drug misuse, mental health

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

SOS Children's Villages, Norway

UNKNOWN

Sponsor Role collaborator

Øvre Eiker municipality

UNKNOWN

Sponsor Role collaborator

Lillehammer municipality

UNKNOWN

Sponsor Role collaborator

Oslo Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anne Grete G Tøge, phd

Role: PRINCIPAL_INVESTIGATOR

associate professor

Eirin G Pedersen, phd

Role: PRINCIPAL_INVESTIGATOR

Senior Researcher

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Øvre Eiker kommune

Drammen, , Norway

Site Status

Larvik kommune

Larvik, , Norway

Site Status

Lillehammer kommune

Lillehammer, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

Finne J, Toge AG, Wiggen KS, Ekre M, Malmberg-Heimonen I, Pontoppidan M, Dion J, Tommeras T, Pedersen E. Results from a randomized controlled pilot trial of a home-visiting intervention to reduce child maltreatment. Pilot Feasibility Stud. 2025 Jun 3;11(1):77. doi: 10.1186/s40814-025-01659-9.

Reference Type DERIVED
PMID: 40462144 (View on PubMed)

Pedersen E, Malmberg-Heimonen I, Finne J, Pontoppidan M, Dion J, Tommeras T, Toge AG. Family Partner: study protocol for a pilot randomised study of a home-visitation intervention in Norway. Scand J Public Health. 2024 Aug;52(6):761-768. doi: 10.1177/14034948231189773. Epub 2023 Aug 14.

Reference Type DERIVED
PMID: 37574994 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

804402

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Holding a Foster Child's Mind in Mind
NCT05196724 ACTIVE_NOT_RECRUITING NA