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

March 10, 2022 updated by: Antje Horsch, Centre Hospitalier Universitaire Vaudois
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Neonatology Service, University Hospital Lausanne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Joint observation and video feedback plus usual care in the neonatology (plus completion of self-report questionnaires and 15 min filmed mother-infant interaction)
Behavioral: joint observation and video feedback
NO_INTERVENTION: Control
Usual care in the neonatology (plus completion of self-report questionnaires and 15 min filmed mother-infant interaction)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perceived Maternal Parenting Self-Efficacy tool
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Posttraumatic Diagnostic Scale
Time Frame: 1 month, 6 months
1 month, 6 months
Parental Stressor Scale: Neonatal Intensive Care Unit
Time Frame: 1 month, 6 months
1 month, 6 months
Parental Stress Index - Short form
Time Frame: 1 month, 6 months
1 month, 6 months
Hospital Anxiety and Depression Scale
Time Frame: 1 month, 6 months
1 month, 6 months
Edinburgh Postnatal Depression Scale
Time Frame: 1 month, 6 months
1 month, 6 months
Mother-to-Infant Bonding Scale
Time Frame: 1 month, 6 months
1 month, 6 months
Infant Behaviour Questionnaire - Revised very short form
Time Frame: 1 month, 6 months
1 month, 6 months
Emotional Availability Scale
Time Frame: 6 months
6 months
Perceived Maternal Parental Self-Efficacy tool
Time Frame: 6 months
6 months
CARE-Index
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Satisfaction with intervention questionnaire
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Vaudois

Investigators

  • Principal Investigator: Antje Horsch, DClinPsych, Clinical and Research Psychologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

August 1, 2020

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (ESTIMATE)

April 13, 2016

Study Record Updates

Last Update Posted (ACTUAL)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 496/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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