AttachMent Preterm in the Loire Infant Follow-up Team (AMPLIFy)

February 9, 2023 updated by: University Hospital, Angers

Attachment Representations of Children Born Prematurely in the Loire Infant Follow-up Team Cohort

The purpose of this study is to describe the attachment representations of children born prematurely at age 3 and 5 with regard to their neurocognitive and behavioral development.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Whether they are born at term or prematurely, from birth, children seek contact with caregivers and establish privileged relationships with them. These attachment relationships are gradually established and, from the end of the first year, interindividual differences can be observed according to temperament, quality of interactions with adults and responses to children's needs for proximity and comfort.

Prematurity is a situation that can disrupt parent-child interactions. The physiological characteristics of the premature infant attenuate and distort his/her stress signals. Visual interactions are shorter, alertness is more labile and reactivity is less clear than that of babies born at term. In such situations of stress and trauma, maternal sensitivity and responsiveness can be affected. In addition, changes in the quality of mother-child interactions have been reported, with more controlling maternal behavior. This maternal trend has been associated with behavioral disorders in children, such as eating disorders or lack of interest in social communication. More frequent disruptions of maternal caregiving associated with relational withdrawal in the child have also been shown in the case of prematurity.

We hypothesize that the experience of establishing relationships with parents in a context of extreme prematurity can alter the development of secure attachment representations in the child and that maternal representations and their possible interactions with prematurity factors prevent or contribute to the development of insecure or disorganized attachment in the child. We also hypothesize that disorganized attachment representations are associated with somatic, environmental, affective, and neurodevelopmental complications (motor, cognitive and behavioral).

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children born prematurely in the French region Pays de la Loire and included in the cohort 'Réseau Grandir Ensemble en Pays de la Loire'.

Description

Inclusion Criteria:

  • Children born in the neonatal reanimation department of Angers and Nantes University Hospitals
  • Extrem preterm infants (term of birth less than or equal to 28 weeks of amenorrhea)
  • Children included in the regional monitoring network for vulnerable newborns (Réseau Grandir Ensemble en Pays de la Loire, RGE)
  • Children with a follow-up consultation at age 3 scheduled as part of the classic RGE follow-up on the Angers and Nantes University Hospitals
  • Informed consent dated and signed by the parents or the holder of the parental authority
  • Affiliated to a Social Security scheme

Exclusion Criteria:

  • Child with severe neurocognitive impairment or severe autism trait-type behavioral disorder in the 2-year RGE follow-up evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AMPLIFy group
Mother, premature child and teacher will complete questionnaires and interviews on attachment, maternal stress and child behavior
Other: Questionnaires and interviews
List of questionnaires: ASQ, PSI, PPQ, SDQ, GSA and AMMI score obtained from mother during two separated interviews for the mother and the child at 3 and 5 years old

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attachment Story Completion Task
Time Frame: Three and five years after preterm birth
The evaluation of attachment representations will be realized at two stages of development, using attachment story stems to complete (Attachment Story Completion Task; Bretherton, Ridgeway & Cassidy, 1990), which is the gold standard tool for measuring this variable between the ages of 3 and 7. Four scores measuring security, deactivation, hyperactivation and disorganization are obtained with the coding system described by Miljkovitch (Miljkovitch et al. 2003). Score on each scale vary from -1 to +1.
Three and five years after preterm birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attachment Multiple Model Interview (AMMI)
Time Frame: Three and five years after preterm birth
The AMMI is a semi-structured interview, which assesses attachment representations regarding specific relationships including relationships with mother, father, and romantic partners (Miljkovitch, Moss, Bernier, Pascuzzo, & Sander, 2015). Scores vary from 0 to 8 for the security, deactivation, and hyperactivation scales and from 0 to 16 for the disorganization.
Three and five years after preterm birth
Parenting Stress Index (PSI) Scale
Time Frame: Three and five years after preterm birth
The PSI is a 120-item self-report questionnaire assessing parenting stress in two main domains: The Parent Domain (51 items) measures stress related to parental functioning, the Child Domain (50 items) measures child qualities and characteristics that contribute to stress in the parent-child system. The PSI contains an additional Life Stress scale (19 items), which will not be used in the study. Scores vary from 50 to 250 in the Parent Domain and from 51 to 255 in the Child Domain. In both domains, higher scores indicate more stress.
Three and five years after preterm birth
Post-traumatic stress disorder Questionnaire (PPQ)
Time Frame: Three and five years after preterm birth
A 14-item self-report questionnaire assessing the level of mothers' post-traumatic stress. A score between 0 and 56 is calculated.
Three and five years after preterm birth
Ages and Stages Questionnaires® (AQS) Questionnaires
Time Frame: Three and five years after preterm birth
The ASQ-3 (and ASQ-5) assess 5 aspects of child development: communication, gross motor skills, fine motor skills, problem solving, and personal-social skills. Each aspect is evaluated through 6 questions. If the answer is yes, score = 10, sometimes = 5 and not yet = 0. The total scores obtained with the ASQ-3 and ASQ-5 range from 0 to 300.
Three and five years after preterm birth
Strengths and Difficulties Questionnaire (SDQ)
Time Frame: Three and five years after preterm birth
The SDQ is a brief parent-report behavioral screening questionnaire for 3-16 year olds. It comprises 20 items relative to 5 categories: emotional problems, conduct problems, hyperactivity/inattention, peer relationship problems and prosocial behavior. The total score obtained with the SDQ is comprised between 0 and 50.
Three and five years after preterm birth
Global School Adaptation (GSA) Score
Time Frame: Five years after preterm birth
The GSA score is an instrument designed for teachers to assess children's abilities and behavior in the classroom with 20 questions. Six questions investigate linguistic competence, five questions investigate non-verbal abilities, eight questions address children's behavior in the classroom and the final question invites the teacher to give his/her prognosis of the child's future adaptation to school life. Total scores vary from 20 to 60.
Five years after preterm birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: Elise Riquin, MD, University Hospital of Angers
  • Study Director: Géraldine Gascoin, MD, University Hospital of Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 7, 2021

Primary Completion (ANTICIPATED)

January 6, 2027

Study Completion (ANTICIPATED)

January 6, 2027

Study Registration Dates

First Submitted

March 10, 2020

First Submitted That Met QC Criteria

March 10, 2020

First Posted (ACTUAL)

March 11, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC19_0132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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