- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04304846
AttachMent Preterm in the Loire Infant Follow-up Team (AMPLIFy)
Attachment Representations of Children Born Prematurely in the Loire Infant Follow-up Team Cohort
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Denise Jolivot, MD
- Phone Number: 33-2-41-35-58-08
- Email: DeJolivot@chu-angers.fr
Study Contact Backup
- Name: Sybille Lazareff, CRA
- Phone Number: 33-2-41-35-33-42
- Email: SyLazareff@chu-angers.fr
Study Locations
-
-
-
Angers, France, 49933
- Recruiting
- University Hospital of Angers
-
Contact:
- Géraldine Gascoin, MD
- Email: GeGascoin@chu-angers.fr
-
Contact:
- Elise Riquin, MD
- Email: Elise.Riquin@chu-angers.fr
-
Nantes, France
- Not yet recruiting
- University Hospital of Nantes
-
Contact:
- Jean-Baptiste Muller, MD
- Email: Jeanbaptiste.MULLER@chu-nantes.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
|
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
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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
Sponsor
Investigators
- Principal Investigator: Elise Riquin, MD, University Hospital of Angers
- Study Director: Géraldine Gascoin, MD, University Hospital of Angers
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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