Impact of an Intervention Program on Parenting Stress After Preterm Birth

Study Overview
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Brief Summary
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The aim of this study was to assess the impact of an early psychological intervention, Triadic parent-infant Relationship Therapy (TRT), on parenting stress, parental mental health, and preterm infant development in the motor, cognitive, emotional and behavioral domains at a corrected age of 18 months.

Detailed Description
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Due to prematurity induced infant-mother separation at birth, sometimes for several weeks, and owing to the concerns it generates, preterm birth exposes the parent-child attachment link to disturbances, especially the mother-child attachment after discharge. Several psychological factors affect infant (distress, dysmaturity ) and parents (psychological pain). These can cause lasting parent-child interactions disruption and jeopardize the attachment process. These early link distortions may hinder the infant's behavioral-emotional and cognitive development. Prematurity psychological consequences may negatively influence biomedical risks. Understanding these premature infants' future development modalities and support involves taking into account intricate organic and psychological factors - which may be combined as well. Post-hospital psychological intervention with the family, focusing on parental mental health and triadic parent-infant relationship, proves an essential element in these children care, whose birth conditions were painful.

Official Title
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Impact of a Psychological Post-hospital Intervention Aimed at Facilitating Parents-child Attachment and Preventing the Preterm Infants' Psycho-emotional, Social and Cognitive Disturbances

Conditions
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Preterm Birth, Parenting, Mental Health Wellness 1, Parent-Child Relation, Child Development

Intervention / Treatment
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* Other: Triadic parent-infant Relationship Therapy (TRT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled preterm infant were required to be between 28 and 35 weeks gestational age +6 days Enrolled the parents were required to be French speakers, over 18 years old and residing within 50-kilometres radius of hospital Exclusion Criteria: preterm infant without congenital anomalies or any other foreseeable disabilities during the neonatal period parents without known psychiatric history

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 35 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preterm intervention TRT group<br>Parents with premature infants received the intervention called Triadic parent-infant's Relationship Therapy (TRT) : the psychological intervention included home visits twice month during the first four months and then monthly visits in the neonatal ward until the 18 months corrected age resulting in a total of 22 visits during the whole intervention; TRT gave attention to emotional distress and the promotion of parenting skills and attachment security; The three sessions of intervention targeted objectives specific to each child's development; A basic manual was designed to ensure uniformity of the defined themes during each session | Other: Triadic parent-infant Relationship Therapy (TRT)<br>* 22 sessions, including home visits twice per month during the first four months, followed by monthly consultations in the neonatology ward, up to corrected age of 18 months.<br>* Other names: TRT;|
| No Intervention: Preterm control group<br>Parents with premature infants without intervention program TRT (Triadic parent-infant's Relationship Therapy) received routine follow-up medical care with monthly visits to a practitioner for the first six months and then very three months | |
| No Intervention: Full-term control group<br>Parents with full-term infants without intervention program TRT | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Parent-Infant Relationship assessed by Parenting Stress Index ( PSI-SF) scores : assessing level of stress in parenting |  | assessments at each time point: at the corrected ages of 3 and 18 months | 
| Change in Parent-Infant Relationship assessed by R interview scores : assessing level of parental self-esteem |  | assessments at each time point: at the corrected ages of 3 and 18 months | 
| Parent-Infant Relationship assessed by Q-sort attachment scores : assessing the score of the attachment security of the infant at the corrected age of 18 months | We needed to use a variety of measures because these measures had to be tailored to the child's stage of development. To ensure the relative strength conclusion on the treatment effect, the statistic analyses of test scores each time point were made using bonefferoni correction for multiple comparisons. Parenting Stress Index ( PSI-SF), R interview and Q-sort attachment were tests based on the infant's age at different assessment periods. | assessment at the corrected age of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parental Mental Health assessed by Post-Traumatic Stress Disorder (PTSD) scores: assessing level of post-traumatic stress |  | assessments at each time point: at 44 weeks gestational age and at the corrected age of 18 months | 
| Change in Parental Mental Health assessed by Beck Depression Inventory (BDI) scores: assessing level of depression |  | assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months | 
| Change in Parental Mental Health assessed by Edinburgh Postnatal Depression Scale (EPDS) scores: assessing level of postpartum depression | The BDI and the EPDS are both based on the frequency of depressive symptoms The statistic analyses were used to compare the evolution of all of the other scores over time. The Post-Traumatic Stress Disorder (PTSD), Beck Depression Inventory (BDI), Edinburgh Postnatal Depression Scale (EPDS) were tests that were resorted to enable us to examine and monitor the preterm birth traumatic impact on parental mental health. | assessments at each time point: at 44 weeks gestational age and at the corrected ages of 3, 9 and18 months | 
| Infant Development assessed by the Neonatal Behavioral Assessment Scale (NBAS) scores: assessing the baby's neurobehavioral development |  | assessments at 44 weeks gestational age | 
| Change in Infant Developmentassessed by the Brunet-Lezine Psychomotor Development Scales: assessing developmental quotient (DQ) |  | assessments at each time point: at the corrected ages of 3, 9 and 18 months | 
| Change in Infant Developmentassessed by Infant Behavioral Symptom scores:assessing scores behaviors and emotional capabilities | The statistic analyses were used to compare the evolution of all of the other scores over time. The Neonatal Behavioral Assessment Scale (NBAS),the Brunet-Lezine Psychomotor Development Scale and Infant Behavioral Symptom were tests that were complementary and enable us to assess infant's various facets of socio-emotional, motor and cognitive development at different stage of development. | assessments at each time point: at the corrected ages of 9 and 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention program, Parenting stress, Parental mental health, Preterm infant's development