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

NCT ID: NCT02736136

Last Updated: 2022-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Posttraumatic Stress Disorder Stress Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

joint observation and video feedback

Intervention Type BEHAVIORAL

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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joint observation and video feedback

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role lead

Responsible Party

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Antje Horsch

Research psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Antje Horsch, DClinPsych

Role: PRINCIPAL_INVESTIGATOR

Clinical and Research Psychologist

Locations

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Neonatology Service, University Hospital Lausanne

Lausanne, Canton of Vaud, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 36138689 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30928952 (View on PubMed)

Other Identifiers

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496/15

Identifier Type: -

Identifier Source: org_study_id

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