NCT04337125

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

2.6 years

First QC Date

April 1, 2020

Last Update Submit

June 4, 2020

Conditions

Keywords

childattachmentparentingADHDexecutive functions

Outcome Measures

Primary Outcomes (2)

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

    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)

    At enrollment

  • Security Scale - version français (SS-vf)

    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.

    At enrollment

Secondary Outcomes (21)

  • 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

  • +16 more secondary outcomes

Study Arms (2)

ADHD group

OTHER

ADHD children with their parents

Other: Neuropsychological and attachment/parenting assessment

Control group

OTHER

Children with typical development and their parents

Other: Neuropsychological and attachment/parenting assessment

Interventions

Children assessments: Mental health assessment, Intellectual functioning assessment, Sleep patterns assessment, Behavior assessment, Severity of ADHD symptoms assessment, child attachment assessment, parenting practices assessment, emotional regulation assessment, Direct measures of attention and executive functions assessment, Indirect measures of attention and executive functions assessment Parents assessments: Mental health assessment, Intellectual functioning assessment, ADHD symptoms assessment, Depression symptoms assessment, Attachment style assessment, Direct measures of attention and executive functions assessment, Indirect measures of attention and executive functions assessment.

ADHD groupControl group

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Universitaire Des Enfants Reine Fabiola

Brussels, 1020, Belgium

RECRUITING

Hôpital Erasme

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Véronique Delvenne, MDPhD

    Queen Fabiola Children's University Hospital

    STUDY DIRECTOR

Central Study Contacts

Jean-François Wylock, Mr

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2020

First Posted

April 7, 2020

Study Start

May 15, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations