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临床试验/NCT04957394
NCT04957394已完成不适用

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

Oslo Metropolitan University3 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
3
主要终点
Acceptability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

研究组 & 干预措施

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.

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.

干预措施: Family Partner (Behavioral)

结局指标

主要结局

Acceptability

时间窗: Acceptability at 12 months

Intervention Rating Profile (IRP-15)

次要结局

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

研究者

发起方
Oslo Metropolitan University
申办方类型
Other
责任方
Sponsor

研究点 (3)

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