An Early Intervention to Increase Maternal Self-efficacy After Preterm Birth

Depression Clinical Trial

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Official title:

An Early Intervention to Increase Maternal Self-efficacy After Preterm Birth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736136
• Other study ID #: 496/15
• Status: Completed
• Phase: N/A
• Start date: August 2016
• Est. completion date: August 2020

Study information

• Verified date: March 2022
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effects of an early intervention (joint observation and video feedback) on maternal parenting self-efficacy following a premature birth. Mothers who have given birth to a very premature baby will be randomly allocated to either the early intervention or usual care whilst the infant is still hospitalized. Participants will be followed up at one month and six months. It is predicted that participants who received the early intervention will report higher maternal parenting self-efficacy than those who are not.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: August 2020
• Est. primary completion date: February 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Mothers of very preterm infants born between 28 and 32 weeks of gestation

• Infant aged up to 8 weeks

Exclusion Criteria:

• Do not speak French sufficiently well to participate in assessments

• Have established intellectual disability or psychotic illness

• Infant too instable regarding hemodynamic or respiratory functioning (severe brady apnea, more than 30% oxygen)

Related Conditions & MeSH terms

• Anxiety
• Depression
• Posttraumatic Stress Disorder
• Premature Birth
• Stress
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• joint observation and video feedback

Locations

Country	Name	City	State
Switzerland	Neonatology Service, University Hospital Lausanne	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction with intervention questionnaire		1 month
Primary	Perceived Maternal Parenting Self-Efficacy tool		1 month
Secondary	Posttraumatic Diagnostic Scale		1 month, 6 months
Secondary	Parental Stressor Scale: Neonatal Intensive Care Unit		1 month, 6 months
Secondary	Parental Stress Index - Short form		1 month, 6 months
Secondary	Hospital Anxiety and Depression Scale		1 month, 6 months
Secondary	Edinburgh Postnatal Depression Scale		1 month, 6 months
Secondary	Mother-to-Infant Bonding Scale		1 month, 6 months
Secondary	Infant Behaviour Questionnaire - Revised very short form		1 month, 6 months
Secondary	Emotional Availability Scale		6 months
Secondary	Perceived Maternal Parental Self-Efficacy tool		6 months
Secondary	CARE-Index		6 months