Joakim Finne, Anne Grete Tøge, Kjersti Stabell Wiggen, Maria Ekre, Ira Malmberg-Heimonen, Maiken Pontoppidan, Jacinthe Dion, Truls Tømmerås, Eirin Pedersen
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引用次数: 0
Abstract
Background: Child maltreatment has severe and lasting consequences, and evidence-based interventions are essential for its prevention. However, few randomized controlled trials (RCTs) have been conducted within child welfare settings in Norway. Pilot trials play an important part in assessing the acceptability and feasibility of such interventions prior to full scale evaluations. This study evaluated the acceptability and feasibility of conducting a full-scale RCT of the Family Partner home-visiting intervention, designed to reduce the risk of child maltreatment.
Methods: Families from three child welfare offices in Norway with at least one child under the age of 12 were invited to participate in this pilot trial. A two-arm randomized design was used, with participants allocated in a 1:1 ratio to either the intervention or control group (n = 45). The intervention group received the home-visiting Family Partner intervention, while the control group received treatment as usual. A qualitative process evaluation was conducted alongside the trial, comprising 29 interviews with Family Partners, caseworkers, participating families, and other stakeholders. Statistical and qualitative analyses evaluated participant acceptability, adherence, and retention.
Results: Qualitative findings indicate a high level of acceptability for the Family Partner intervention across all stakeholder groups. Adherence was strong, with no participants withdrawing consent and only two opting out of subsequent surveys. However, participant retention declined over time, with survey response rates dropping at each time point and only 42% completing the final assessment.
Conclusions: This pilot trial provides preliminary evidence supporting the acceptability of the Family Partner intervention within child welfare services and highlights important considerations regarding the feasibility of conducting RCTs in this setting.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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