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Completed

NCT Number: NCT02736136

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

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.

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Key information

Conditions

Posttraumatic Stress Disorder Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Stress Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Neonatology Service, University Hospital Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

joint observation and video feedback

Behavioral

Primary outcomes

  1. Perceived Maternal Parenting Self-Efficacy tool

    Time frame: 1 month

Secondary outcomes

  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 outcomes

  1. Satisfaction with intervention questionnaire

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Acronym: JOIN

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2016
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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