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Life sciences · Interventional Study
ClinicalTrials.gov · October 22, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06791876). This is a study registration, not published results. Lead sponsor: Center for Clinical Research and Prevention. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 20 participants (ACTUAL). Conditions: Depression, Anxiety, Intervention, Randomized Controlled Study. Interventions: BEHAVIORAL: Nurture and Play (NnP). Primary outcome measures: The feasibility of the NnP including both parents (The recruitment procedure and the adherence to the intervention) , 1 year; The participant's and professional´s experience of the intervention as well as the collaboration between the hospitals and the municipalities. , Approximately 30 minutes per interview. Brief summary: The aim of this randomised controlled pilot study is to evaluate the feasibility of the Nurture and Play (NnP) offered to a Danish population of psychosocial vulnerable pregnant women and their partners. More specifically the objectives of the study are to: * Test the feasibility of the NnP including both parents * Evaluate the recruitment procedure, the adherence as well as the participant's and professional´s experience of the intervention * Evaluate the collaboration between the hospitals and the municipalities. The study consists of: 1. A randomized controlled pilot study (n=20 women/couples) carried out according to the Standard Protocol Items: Recommendations for Interventional Trials SPIRIT statement for clinical trials. The parents who agree to participate in the study will be randomly assigned in a 1:1 ratio to either the intervention or the control group. In addition to care-as-usual, the intervention group will be offered to participate in the NnP adapted to include partners. The intervention consists of 11 group sessions (4 perinatal and 7 postnatal sessions) and will be provided to the parents in the intervention group from around 26 weeks gestation until the baby is around seven months old. Each group session will be led by a midwife and a health nurse and will consist of four to five mothers/couples. 2. A qualitative descriptive interview study aiming to evaluate the participants' and professionals´ experience of the intervention. Data will be collected through: * Online Questionnaires. * Interviews. * Videotaped settings.