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Clinical Trials/NCT04957394
NCT04957394
Completed
Not Applicable

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

Oslo Metropolitan University3 sites in 1 country45 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Family
Sponsor
Oslo Metropolitan University
Enrollment
45
Locations
3
Primary Endpoint
Acceptability
Status
Completed
Last Updated
8 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
September 18, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Oslo Metropolitan University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Acceptability

Time Frame: Acceptability at 12 months

Intervention Rating Profile (IRP-15)

Secondary Outcomes

  • Relationship between the Family Partner and the parents(Change from Baseline WAI at 3, 6, 9, 12, 15 and 18 months)

Study Sites (3)

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