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Clinical Trials/NCT04337125
NCT04337125
Unknown
N/A

Cross-sectional Study Assessing the Contribution of Attachment and Educational Practices in the Expression of ADHD in School-aged ADHD Children and Control Group

Queen Fabiola Children's University Hospital2 sites in 1 country160 target enrollmentMay 15, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Queen Fabiola Children's University Hospital
Enrollment
160
Locations
2
Primary Endpoint
Cartes pour l'évaluation de l'Attachement et de la Mentalisation chez l'Enfant (CAME)
Last Updated
5 years ago

Overview

Brief Summary

ADHD is a neurodevelopmental disorder characterized by the presence of persistent signs of associated hyperactivity-impulsivity and/or inattention that impair the child's functioning or development.

The involvement of genetic factors has been shown in numerous studies. Other studies have also highlighted the contributions of parent-child interaction in the development, expression and persistence of symptoms.However, the mechanisms by which parenting practices and attachment may influence ADHD symptoms remain unclear.

The aim of this study is to evaluate the influence of attachment style of the child, the educational practices and the presence of attentional/executive disorders of parents on the expression of ADHD in children aged 7 to 10.

This prospective empirical research will compare children with ADHD and their parents to a matched control group.

Registry
clinicaltrials.gov
Start Date
May 15, 2020
End Date
December 31, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or female patients ages 7 to ≤10 years with ADHD (study group) or TD children matched by gender and socio-economic factors (control group) and their parents.
  • French-speaking population Willing and able to comply with scheduled visits and study procedures. Written informed consent/assent, according to local guidelines, signed by the patient and / or by the parents or legal guardian prior to any study related screening procedures are performed.

Exclusion Criteria

  • Children with intellectual disabilities (IQ \<80). Epilepsy. Prematurity. Objectified neurological sequelae. Specific language impairment or severe learning disabilities. Contraindication to stopping treatment for ADHD

Outcomes

Primary Outcomes

Cartes pour l'évaluation de l'Attachement et de la Mentalisation chez l'Enfant (CAME)

Time Frame: At enrollment

CAME is a child interview validated in french and allowing to assess the attachment representations and mentalization on base of interview for child between 7 and 14 years. The aim of interview is to tell the child the emotional relationships with parents (e.g. : "Can you tell me a moment where your mom/dad was mad at you" ? or "did you ever feel bad about yourself, feel bad about yourself ? "). The interview with child is recorded and transcribed word for word for the correction. In order to increasing quality of rating, 20% of interview will be recorded by a second evaluator (Pr Ayala Borghini)

Security Scale - version français (SS-vf)

Time Frame: At enrollment

The child is asked to complete two questionnaires with each 10 items, one for the mother, the other for the father. Responses to each item are scored on a 4-point scale. In the version validated in French, the scores vary from 10 to 40. The highest scores correspond to the highest security of attachment to the parent.

Secondary Outcomes

  • Parent Education Practices Assessment Questionnaire (PEP)(At enrollment)
  • Parent Educational Practices perceived by the child (PEPPE)(At enrollment)
  • Behavioral Rating Inventory Executive Function (BRIEF)(At enrollment)
  • Behavioral Rating Inventory Executive Function for Adult (BRIEF-A)(At enrollment)
  • Test of Attentional Performance (TAP)(At enrollment)
  • Stroop(At enrollment)
  • Counting Stroop Task(At enrollment)
  • Tower of London(At enrollment)
  • Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS)(At enrollment)
  • Emotional Regulation Checklist - version française (ERC-vf)(At enrollment)
  • Children Behavior Checklist (CBCL)(At enrollment)
  • Revised Card Sorting Test (RCST)(At enrollment)
  • Kiddie-SADS-PL(At enrollment)
  • Wechsler Intelligence Scale for Children 5th edition (WISC-V)(At enrollment)
  • Wechsler Adult Intelligence Scale 4th edition (WAIS-IV)(At enrollment)
  • Mini International Neuropsychiatric Interview (MINI)(At enrollment)
  • ADHD Adult Scale Rating Scale (ASRS)(At enrollment)
  • Wenders Utah Rating Scale (WURS)(At enrollment)
  • Relationship Scale Questionnaire (RSQ)(At enrollment)
  • Beck Depression Inventory-II (BDI-II)(At enrollment)
  • Children's Sleep Habit Questionnaire (CSHQ)(At enrollment)

Study Sites (2)

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