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

Primary Purpose

Posttraumatic Stress Disorder, Stress, Anxiety

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

joint observation and video feedback

About this trial

This is an interventional prevention trial for Posttraumatic Stress Disorder focused on measuring maternal parenting self-efficacy, parental stress, maternal sensitivity, mother-infant bond

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

Neonatology Service, University Hospital Lausanne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Joint observation and video feedback plus usual care in the neonatology (plus completion of self-report questionnaires and 15 min filmed mother-infant interaction)

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

Outcomes

Primary Outcome Measures

Perceived Maternal Parenting Self-Efficacy tool

Secondary Outcome Measures

Posttraumatic Diagnostic Scale

Parental Stressor Scale: Neonatal Intensive Care Unit

Parental Stress Index - Short form

Hospital Anxiety and Depression Scale

Edinburgh Postnatal Depression Scale

Mother-to-Infant Bonding Scale

Infant Behaviour Questionnaire - Revised very short form

Emotional Availability Scale

Perceived Maternal Parental Self-Efficacy tool

CARE-Index

Full Information

NCT ID

NCT02736136

First Posted

April 4, 2016

Last Updated

March 10, 2022

Sponsor

Centre Hospitalier Universitaire Vaudois

1. Study Identification

Unique Protocol Identification Number

NCT02736136

Brief Title

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

Acronym

JOIN

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

August 2016 (undefined)

Primary Completion Date

February 2020 (Actual)

Study Completion Date

August 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier Universitaire Vaudois

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder, Stress, Anxiety, Depression

Keywords

maternal parenting self-efficacy, parental stress, maternal sensitivity, mother-infant bond

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

71 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Joint observation and video feedback plus usual care in the neonatology (plus completion of self-report questionnaires and 15 min filmed mother-infant interaction)

Arm Title

Control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

joint observation and video feedback

Primary Outcome Measure Information:

Title

Perceived Maternal Parenting Self-Efficacy tool

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Posttraumatic Diagnostic Scale

Time Frame

1 month, 6 months

Title

Parental Stressor Scale: Neonatal Intensive Care Unit

Time Frame

1 month, 6 months

Title

Parental Stress Index - Short form

Time Frame

1 month, 6 months

Title

Hospital Anxiety and Depression Scale

Time Frame

1 month, 6 months

Title

Edinburgh Postnatal Depression Scale

Time Frame

1 month, 6 months

Title

Mother-to-Infant Bonding Scale

Time Frame

1 month, 6 months

Title

Infant Behaviour Questionnaire - Revised very short form

Time Frame

1 month, 6 months

Title

Emotional Availability Scale

Time Frame

6 months

Title

Perceived Maternal Parental Self-Efficacy tool

Time Frame

6 months

Title

CARE-Index

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Satisfaction with intervention questionnaire

Time Frame

1 month

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antje Horsch, DClinPsych

Organizational Affiliation

Clinical and Research Psychologist

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neonatology Service, University Hospital Lausanne

City

Lausanne

State/Province

Vaud

ZIP/Postal Code

1011

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36138689

Citation

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.

Results Reference

derived

PubMed Identifier

30928952

Citation

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.

Results Reference

derived

Learn more about this trial

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

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