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NCT Number: NCT04304846

AttachMent Preterm in the Loire Infant Follow-up Team

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.

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Key information

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Angers, Angers, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires and interviews

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Denise Jolivot, MD

CONTACT

[email protected]

33-2-41-35-58-08

Sybille Lazareff, CRA

CONTACT

[email protected]

33-2-41-35-33-42

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: AMPLIFy

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Mar 11, 2020
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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