NCT02736136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

3.5 years

First QC Date

April 4, 2016

Last Update Submit

March 10, 2022

Conditions

Posttraumatic Stress DisorderStressAnxietyDepression

Keywords

maternal parenting self-efficacyparental stressmaternal sensitivitymother-infant bond

Outcome Measures

Primary Outcomes (1)

  • Perceived Maternal Parenting Self-Efficacy tool

    1 month

Secondary Outcomes (10)

  • Posttraumatic Diagnostic Scale

    1 month, 6 months

  • Parental Stressor Scale: Neonatal Intensive Care Unit

    1 month, 6 months

  • Parental Stress Index - Short form

    1 month, 6 months

  • Hospital Anxiety and Depression Scale

    1 month, 6 months

  • Edinburgh Postnatal Depression Scale

    1 month, 6 months

  • +5 more secondary outcomes

Other Outcomes (1)

  • Satisfaction with intervention questionnaire

    1 month

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

Usual care in the neonatology (plus completion of self-report questionnaires and 15 min filmed mother-infant interaction)

Interventions

joint observation and video feedbackBEHAVIORAL
Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mothers of very preterm infants born between 28 and 32 weeks of gestation
  • Infant aged up to 8 weeks

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatology Service, University Hospital Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

  • Lovey O, Bickle-Graz M, Morisod Harari M, Horsch A, Schneider J; JOIN Research Consortium. The Joint Observation in Neonatology and Neurodevelopmental Outcome of Preterm Infants at Six Months Corrected Age: Secondary Outcome Data from a Randomised Controlled Trial. Children (Basel). 2022 Sep 13;9(9):1380. doi: 10.3390/children9091380.

    PMID: 36138689DERIVED

  • Schneider J, Borghini A, Morisod Harari M, Faure N, Tenthorey C, Le Berre A, Tolsa JF, Horsch A; JOIN Research Consortium. Joint observation in NICU (JOIN): study protocol of a clinical randomised controlled trial examining an early intervention during preterm care. BMJ Open. 2019 Mar 30;9(3):e026484. doi: 10.1136/bmjopen-2018-026484.

    PMID: 30928952DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Antje Horsch, DClinPsych

    Clinical and Research Psychologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research psychologist

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 13, 2016

Study Start

August 1, 2016

Primary Completion

February 1, 2020

Study Completion

August 1, 2020

Last Updated

March 25, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)