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

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ClinicalTrials.gov Identifier: NCT02736136
Recruitment Status : Unknown
Verified July 2018 by Antje Horsch, Centre Hospitalier Universitaire Vaudois.
Recruitment status was:  Recruiting
First Posted : April 13, 2016
Last Update Posted : July 19, 2018
Sponsor:
Information provided by (Responsible Party):
Antje Horsch, Centre Hospitalier Universitaire Vaudois

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Stress Anxiety Depression Behavioral: joint observation and video feedback Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Early Intervention to Increase Maternal Self-efficacy After Preterm Birth
Study Start Date : April 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019
Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  1. Perceived Maternal Parenting Self-Efficacy tool [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Posttraumatic Diagnostic Scale [ Time Frame: 1 month, 6 months ]
  2. Parental Stressor Scale: Neonatal Intensive Care Unit [ Time Frame: 1 month, 6 months ]
  3. Parental Stress Index - Short form [ Time Frame: 1 month, 6 months ]
  4. Hospital Anxiety and Depression Scale [ Time Frame: 1 month, 6 months ]
  5. Edinburgh Postnatal Depression Scale [ Time Frame: 1 month, 6 months ]
  6. Mother-to-Infant Bonding Scale [ Time Frame: 1 month, 6 months ]
  7. Infant Behaviour Questionnaire - Revised very short form [ Time Frame: 1 month, 6 months ]
  8. Emotional Availability Scale [ Time Frame: 6 months ]
  9. Perceived Maternal Parental Self-Efficacy tool [ Time Frame: 6 months ]
  10. CARE-Index [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Satisfaction with intervention questionnaire [ Time Frame: 1 month ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736136


Contacts
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Contact: Antje Horsch, DClinPsych. +41 79 556 07 50 antje.horsch@chuv.ch
Contact: Noémie Faure, M.Sc. +41 21 314 17 47 noemie.faure@chuv.ch

Locations
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Switzerland
Neonatology Service, University Hospital Lausanne Recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Jean-François Tolsa, Ph.D.    +4121 314 36 92    jean-francois.tolsa@chuv.ch   
Contact: Noémie Faure    +41213144233    noemie.faure@chuv.ch   
Principal Investigator: Horsch Antje, D.Clin.Psych.         
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
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Principal Investigator: Antje Horsch, DClinPsych Clinical and Research Psychologist
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Antje Horsch, Research psychologist, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT02736136    
Other Study ID Numbers: 496/15
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Antje Horsch, Centre Hospitalier Universitaire Vaudois:
maternal parenting self-efficacy
parental stress
maternal sensitivity
mother-infant bond
Additional relevant MeSH terms:
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Premature Birth
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
 Mental Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications