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Completed

NCT Number: NCT04957394

Pilot Trial of Family Partner - a Child Maltreatment Prevention Intervention

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.

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Key information

Conditions

Family Child Maltreatment Parenting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Øvre Eiker kommune, Drammen, Norway

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About this study

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:

  • What is the adaptability, acceptability, and feasibility of the Family Partner intervention in a Norwegian municipal context?
  • What are the experiences and possible outcomes of the Family Partner intervention?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Partner

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.

Primary outcomes

  1. Acceptability

    Time frame: Acceptability at 12 months

    Intervention Rating Profile (IRP-15)

Secondary outcomes

  1. Relationship between the Family Partner and the parents

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

    The Working Alliance Inventory (WAI)

Sponsors and collaborators

Lead sponsor

Oslo Metropolitan University

Other

Collaborators

  • Lillehammer municipality
  • SOS Children's Villages, Norway
  • Øvre Eiker municipality

Registry information

Official study title

Family Partner -Co-development, Implementation and Evaluation of a Child Maltreatment Prevention Intervention

Acronym: FAMPART

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 12, 2021
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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