Anxiety Clinical Trial
Official title:
The Change Mechanisms of the Close Collaboration With Parents Intervention and the Adaptability of the Intervention in the Estonian Context
The overall aim of the study is to implement an evidence-based intervention called 'Close Collaboration with Parents' in Estonian neonatal units. The goal of the intervention is to educate the whole multi-professional NICU staff and promote a positive change in the family-centered care culture of the units. Thus, the first aim of the study is to implement the intervention in an Estonian NICU context, in three hospitals, and study the fidelity of the intervention. More precisely, the study questions are whether adaptations are needed for the successful implementation of the intervention in the Estonian context and how feasible are the used implementation strategies. Secondly, the aim is to study the effectiveness of the Close Collaboration with Parents intervention in this context by using a quasi-experimental, pre-test - post-test, study design. The questions are whether the implementation of the intervention in the Estonian setting will result in positive effects such as 1) an improved development environment for the infants during hospital stay (less noise, more parental speech, and more parent-infant physical closeness), 2) intensified parental bonding to the infant, and 3) increased parental confidence and emotional well-being at the time of discharge from hospital.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | February 12, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: The inclusion criteria for the families are: 1. families whose newborns have been hospitalized during the first 28 days of infant life 2. expected length of stay of the newborn is at least three days 3. discharge is planned to happen within a week 4. at least one parent has agreed to participate in the study The exclusion criterion for the families: 1) Not able to communicate in Estonian, Russian, or English. The inclusion criterion for the staff members: 1) The staff working in the units during the entire study period are eligible for the study. |
Country | Name | City | State |
---|---|---|---|
Finland | Sari Ahlqvist-Björkroth | Turku |
Lead Sponsor | Collaborator |
---|---|
University of Turku | University of Tartu |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Parenting self-efficacy | Parenting self-efficacy is measured using the Perceived Maternal Parenting Self-Efficacy questionnaire. The questionnaire consists of 20 items. The total score on the scale ranges from 20 to 80. A high score indicates more parenting self-efficacy. | Up to 2 months | |
Other | Readiness for discharge | The readiness for discharge is measured with the Readiness for Hospital Discharge Scale. The questionnaire includes 23 items. The total score on the scale ranges from 0 to 230. A high score indicates more readiness for discharge. | Up to 2 months | |
Other | Family-centered care | The parent participation and the support parents feel they receive from the staff are measured using a questionnaire modified from Digital Family-Centered Care questions that were made for the Short Message Service. The questionnaire includes 9 items. The total score on the scale ranges from 7 to 49. A high score indicates more that the received care is experienced as more family-centered. | Up to 2 months | |
Other | Reflective thinking | The level of reflective thinking of the staff is measured using the Reflective Thinking Measure. The 16-question measure determines whether an individual engages in reflective thinking and to what extent s/he does that. Scores range from 16 to 80, with 80 indicating the highest possible level of reflection. | Through study completion, an average of 2 years and 2 months | |
Primary | Depression | The postnatal depressive symptoms of the mothers whose newborn has been cared for in the unit after the intervention are compared with the postnatal depressive symptoms of the mothers whose newborn has been cared for in the unit before the intervention. The symptoms are measured with Edinburgh Postnatal Depression Scale. The 10-question scale includes symptoms such as insomnia, mood, tearfulness, and thoughts of self-harm. The scale asks how a person has felt during the previous week. The minimum score is 0 and the maximum is 30. A high score indicates more depressive symptoms. | Up to 2 months | |
Secondary | Anxiety | The measurement provides separate scores for both state and trait anxiety. There are 20 questions about state anxiety with a minimum score of 20 and a maximum of 80 and 20 questions about trait anxiety with the same minimum and maximum scores. A high score indicates more anxiety symptoms. | Up to 2 months |
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