NCT04957394

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2024

Completed
Last Updated

August 11, 2025

Status Verified

April 1, 2025

Enrollment Period

2.7 years

First QC Date

June 28, 2021

Last Update Submit

August 5, 2025

Conditions

FamilyParentingChild Maltreatment

Outcome Measures

Primary Outcomes (1)

  • Acceptability

    Intervention Rating Profile (IRP-15)

    Acceptability at 12 months

Secondary Outcomes (1)

  • Relationship between the Family Partner and the parents

    Change from Baseline WAI at 3, 6, 9, 12, 15 and 18 months

Study Arms (2)

Experimental (Family Partner)

EXPERIMENTAL

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

Behavioral: Family Partner

Control group

NO INTERVENTION

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.

Interventions

Family PartnerBEHAVIORAL

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.

Experimental (Family Partner)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Øvre Eiker kommune

Drammen, Norway

Location

Larvik kommune

Larvik, Norway

Location

Lillehammer kommune

Lillehammer, Norway

Location

Related Publications (2)

  • 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.

    PMID: 40462144DERIVED

  • 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.

    PMID: 37574994DERIVED

Study Officials

  • Anne Grete G Tøge, phd

    associate professor

    PRINCIPAL INVESTIGATOR

  • Eirin G Pedersen, phd

    Senior Researcher

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 12, 2021

Study Start

January 1, 2022

Primary Completion

September 18, 2024

Study Completion

September 18, 2024

Last Updated

August 11, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(3)