Clinical Trials Directory

Trials / Completed

CompletedNCT04957394

Pilot Trial of Family Partner - a Child Maltreatment Prevention Intervention

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
45 (actual)
Sponsor
Oslo Metropolitan University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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

Interventions

TypeNameDescription
BEHAVIORALFamily PartnerThe 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.

Timeline

Start date
2022-01-01
Primary completion
2024-09-18
Completion
2024-09-18
First posted
2021-07-12
Last updated
2025-08-11

Locations

3 sites across 1 country: Norway

Source: ClinicalTrials.gov record NCT04957394. Inclusion in this directory is not an endorsement.