AttachMent Preterm in the Loire Infant Follow-up Team

Preterm Birth Clinical Trial

— AMPLIFy  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04304846
• Other study ID #: 49RC19_0132
• Status: Recruiting
• Start date: January 7, 2021
• Est. completion date: January 6, 2027

Study information

• Verified date: June 2024
• Source: University Hospital, Angers
• Contact: Denise Jolivot, MD
• Phone: 33-2-41-35-58-08
• Email: DeJolivot[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 6, 2027
• Est. primary completion date: January 6, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Birth

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Angers	Angers
France	University Hospital of Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attachment Story Completion Task	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	Attachment Multiple Model Interview (AMMI)	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
Secondary	Parenting Stress Index (PSI) Scale	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
Secondary	Post-traumatic stress disorder Questionnaire (PPQ)	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
Secondary	Ages and Stages Questionnaires® (AQS) Questionnaires	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
Secondary	Strengths and Difficulties Questionnaire (SDQ)	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
Secondary	Global School Adaptation (GSA) Score	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