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

Study Overview
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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.

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

Conditions
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Posttraumatic Stress Disorder, Stress, Anxiety, Depression

Intervention / Treatment
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* Behavioral: joint observation and video feedback


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br> <br> |
| No Intervention: Control<br>Usual care in the neonatology (plus completion of self-report questionnaires and 15 min filmed mother-infant interaction) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Maternal Parenting Self-Efficacy tool |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Mother-to-Infant Bonding Scale |  | 1 month, 6 months | 
| Infant Behaviour Questionnaire - Revised very short form |  | 1 month, 6 months | 
| Emotional Availability Scale |  | 6 months | 
| Perceived Maternal Parental Self-Efficacy tool |  | 6 months | 
| CARE-Index |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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maternal parenting self-efficacy, parental stress, maternal sensitivity, mother-infant bond