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Contribution of Attachment and Educational Practices in the Expression of ADHD in School-aged Children (CASPI-ADHD)

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Neuropsychological and attachment/parenting assessment
Sponsored by
Queen Fabiola Children's University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Attention Deficit Hyperactivity Disorder focused on measuring child, attachment, parenting, ADHD, executive functions

Eligibility Criteria

7 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hôpital Universitaire Des Enfants Reine FabiolaRecruiting
  • Hôpital ErasmeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

ADHD group

Control group

Arm Description

ADHD children with their parents

Children with typical development and their parents

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Parent Education Practices Assessment Questionnaire (PEP)
PEP is a questionaire completed by parents to assess parents' child-rearing behavior and included 35 questions divided into 9 factors: positive parenting, monitoring, rules, punishment, ignorance, maternal reward and autonomy. This questionnaire will be used to compare the distribution of parenting practices in children with AHDH and with TD group
Parent Educational Practices perceived by the child (PEPPE)
PEPPE is a questionaire completed by child and is composed to 18 questions to assess perception of parenting practices.
Behavioral Rating Inventory Executive Function (BRIEF)
BRIEF is a questionnaire rated by parents to assess child's executive functioning and is composed of a 86 items. Each item is rated on 0-2 scale. Higher scores indicate more executive difficulties.
Behavioral Rating Inventory Executive Function for Adult (BRIEF-A)
BRIEF-A is a self-report to assess parent's executive functioning in parent and includes 75 items. Each item is rated on 0-2 scale. Higher scores indicate more executive difficulties.
Test of Attentional Performance (TAP)
TAP is a computerized battery allowing attentional performances and different executive functions such as alertness, divided attention, motor inhibition, flexibility.
Stroop
This task includes three conditions: denomination, reading, interference. In the denomination condition, adult must saw as quickly as possible the color of each square presented in line. In the reading condition adult must read as quickly as the name of colors presented in line in black ink (congruent condition). In the interference condition, he must say the color of the ink of word (names of colors in a different ink than the color named) and thus inhibit the automatic treatment of read.
Counting Stroop Task
This task includes three conditions : counting, reading, interference. Items were presented on a computer screen in 10 lines, presented one at time, with 10 stimuli per line (squares with numbers or dots). In the counting condition, children had to report as fast as possible the number of dots within each square. In the reading condition, they had to read the number written within each square. In the interference condition, they had to report how many numbers were written within each square, while avoiding reading the number itself. Important variables for analysis are number of errors and time in interference condition.
Tower of London
The test consists of a support with three rods of different heights and three beads of different colors. The individual must reproduce, on the support and in a determined number of movements, a particular configuration proposed by the examiner. Important variable is the number of excess movements.
Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS)
ADHD-RS is a questionnaire rated by parents to assess severity of ADHD and is composed of 18 items on 0-3 point scale. Higher scores indicates more ADHD symptoms.
Emotional Regulation Checklist - version française (ERC-vf)
ERC-vf is a questionnaire rated by parents to assess abilities of emotional regulation and emotional dysregulation of child and is composed to 24 items divided in two scale. Each item is rated on 0-4 scale. Higher score in emotional dysregulation scale indicate more difficulty. Higher score in scale of emotional regulation indicate more competence for regulate emotions.
Children Behavior Checklist (CBCL)
CBCL is a questionnaire rated by parents to assess child's behavior and presence of comorbid disorders such as anxiety, depression or oppositional disorders and is composed of 118 items. Each item is rated on 0-2 scale. Raw scores were converted on T-scores on three large scales (Internalising, Externalising, Total) and eight syndrome scales (Aggressive Behavior, Anxious/Depressed, Attention, Problems, Rule-Breaking Behavior, Social Problems, Somatic Complaints, Thought Problems, Withdrawn/Depressed). Higher scores indicate more difficulty.
Revised Card Sorting Test (RCST)
Cognitive flexibility of child will be assessed with RCST. Children must classed a set of 48 card according to three possibles categories (color, shape and number). Child must inferred the correct category on base examinator feedback. Important variable is the number of errors.
Kiddie-SADS-PL
The evaluation of child and adolescent mental health disorder is assessed by the Kiddie-SADS-PL DSM-5, a semi-structured diagnostic interview for children and adolescents
Wechsler Intelligence Scale for Children 5th edition (WISC-V)
The child intellectual functioning will be assessed using the WISC-V (Wechsler, 2016). The Digit span subtest will be using as measure of working memory
Wechsler Adult Intelligence Scale 4th edition (WAIS-IV)
The parental intellectual functioning will be assessed with the WAIS-IV subtests of Matrices and Figure weight. The Digit span subtest will be using as measure of working memory.
Mini International Neuropsychiatric Interview (MINI)
MINI is a semi-structured diagnostic interview for adults validated in french (Lecrubier & al., 1997). Current and past symptoms of psychopathology are assessed in order to establish one or more diagnoses according to the DSM-5 criteria.
ADHD Adult Scale Rating Scale (ASRS)
ASRS is a self-questionnaire to assess presence and severity of ADHD symptoms in parents and is composed of 18 items on 0-3 point scale. Higher scores indicates more ADHD symptoms.
Wenders Utah Rating Scale (WURS)
WURS is a self-questionnaire completed by parent that allows to assess retrospectively the presence of attentional difficulties and hyperactivity signs in childhood. The french version included 25 items rated from 0 to 4 depending on the severity of the behavior. Higher scores indicate more difficulty.
Relationship Scale Questionnaire (RSQ)
RSQ is a self-questionnaire of 30 items destined to assess the attachment style of adult (Secure, Fearful, Preoccupied and Detached). The adult rates each item on Likert scale in 5 points according to what looks most like him.
Beck Depression Inventory-II (BDI-II)
BDI-II is a self-report to assess presence of depressive symptoms in parent and includes 21 items. Each item is rated on 0-3 scale. Higher scores indicate more depressive symptoms
Children's Sleep Habit Questionnaire (CSHQ)
CSHQ is questionnaire rated by parents and is composed of 35 items on 1-3 point scale. Higher scores indicates more sleep disorders.

Full Information

First Posted
April 1, 2020
Last Updated
June 4, 2020
Sponsor
Queen Fabiola Children's University Hospital
Collaborators
The Belgian Kids' Fund
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1. Study Identification

Unique Protocol Identification Number
NCT04337125
Brief Title
Contribution of Attachment and Educational Practices in the Expression of ADHD in School-aged Children
Acronym
CASPI-ADHD
Official Title
Cross-sectional Study Assessing the Contribution of Attachment and Educational Practices in the Expression of ADHD in School-aged ADHD Children and Control Group
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Fabiola Children's University Hospital
Collaborators
The Belgian Kids' Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
child, attachment, parenting, ADHD, executive functions

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADHD group
Arm Type
Other
Arm Description
ADHD children with their parents
Arm Title
Control group
Arm Type
Other
Arm Description
Children with typical development and their parents
Intervention Type
Other
Intervention Name(s)
Neuropsychological and attachment/parenting assessment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cartes pour l'évaluation de l'Attachement et de la Mentalisation chez l'Enfant (CAME)
Description
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)
Time Frame
At enrollment
Title
Security Scale - version français (SS-vf)
Description
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.
Time Frame
At enrollment
Secondary Outcome Measure Information:
Title
Parent Education Practices Assessment Questionnaire (PEP)
Description
PEP is a questionaire completed by parents to assess parents' child-rearing behavior and included 35 questions divided into 9 factors: positive parenting, monitoring, rules, punishment, ignorance, maternal reward and autonomy. This questionnaire will be used to compare the distribution of parenting practices in children with AHDH and with TD group
Time Frame
At enrollment
Title
Parent Educational Practices perceived by the child (PEPPE)
Description
PEPPE is a questionaire completed by child and is composed to 18 questions to assess perception of parenting practices.
Time Frame
At enrollment
Title
Behavioral Rating Inventory Executive Function (BRIEF)
Description
BRIEF is a questionnaire rated by parents to assess child's executive functioning and is composed of a 86 items. Each item is rated on 0-2 scale. Higher scores indicate more executive difficulties.
Time Frame
At enrollment
Title
Behavioral Rating Inventory Executive Function for Adult (BRIEF-A)
Description
BRIEF-A is a self-report to assess parent's executive functioning in parent and includes 75 items. Each item is rated on 0-2 scale. Higher scores indicate more executive difficulties.
Time Frame
At enrollment
Title
Test of Attentional Performance (TAP)
Description
TAP is a computerized battery allowing attentional performances and different executive functions such as alertness, divided attention, motor inhibition, flexibility.
Time Frame
At enrollment
Title
Stroop
Description
This task includes three conditions: denomination, reading, interference. In the denomination condition, adult must saw as quickly as possible the color of each square presented in line. In the reading condition adult must read as quickly as the name of colors presented in line in black ink (congruent condition). In the interference condition, he must say the color of the ink of word (names of colors in a different ink than the color named) and thus inhibit the automatic treatment of read.
Time Frame
At enrollment
Title
Counting Stroop Task
Description
This task includes three conditions : counting, reading, interference. Items were presented on a computer screen in 10 lines, presented one at time, with 10 stimuli per line (squares with numbers or dots). In the counting condition, children had to report as fast as possible the number of dots within each square. In the reading condition, they had to read the number written within each square. In the interference condition, they had to report how many numbers were written within each square, while avoiding reading the number itself. Important variables for analysis are number of errors and time in interference condition.
Time Frame
At enrollment
Title
Tower of London
Description
The test consists of a support with three rods of different heights and three beads of different colors. The individual must reproduce, on the support and in a determined number of movements, a particular configuration proposed by the examiner. Important variable is the number of excess movements.
Time Frame
At enrollment
Title
Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS)
Description
ADHD-RS is a questionnaire rated by parents to assess severity of ADHD and is composed of 18 items on 0-3 point scale. Higher scores indicates more ADHD symptoms.
Time Frame
At enrollment
Title
Emotional Regulation Checklist - version française (ERC-vf)
Description
ERC-vf is a questionnaire rated by parents to assess abilities of emotional regulation and emotional dysregulation of child and is composed to 24 items divided in two scale. Each item is rated on 0-4 scale. Higher score in emotional dysregulation scale indicate more difficulty. Higher score in scale of emotional regulation indicate more competence for regulate emotions.
Time Frame
At enrollment
Title
Children Behavior Checklist (CBCL)
Description
CBCL is a questionnaire rated by parents to assess child's behavior and presence of comorbid disorders such as anxiety, depression or oppositional disorders and is composed of 118 items. Each item is rated on 0-2 scale. Raw scores were converted on T-scores on three large scales (Internalising, Externalising, Total) and eight syndrome scales (Aggressive Behavior, Anxious/Depressed, Attention, Problems, Rule-Breaking Behavior, Social Problems, Somatic Complaints, Thought Problems, Withdrawn/Depressed). Higher scores indicate more difficulty.
Time Frame
At enrollment
Title
Revised Card Sorting Test (RCST)
Description
Cognitive flexibility of child will be assessed with RCST. Children must classed a set of 48 card according to three possibles categories (color, shape and number). Child must inferred the correct category on base examinator feedback. Important variable is the number of errors.
Time Frame
At enrollment
Title
Kiddie-SADS-PL
Description
The evaluation of child and adolescent mental health disorder is assessed by the Kiddie-SADS-PL DSM-5, a semi-structured diagnostic interview for children and adolescents
Time Frame
At enrollment
Title
Wechsler Intelligence Scale for Children 5th edition (WISC-V)
Description
The child intellectual functioning will be assessed using the WISC-V (Wechsler, 2016). The Digit span subtest will be using as measure of working memory
Time Frame
At enrollment
Title
Wechsler Adult Intelligence Scale 4th edition (WAIS-IV)
Description
The parental intellectual functioning will be assessed with the WAIS-IV subtests of Matrices and Figure weight. The Digit span subtest will be using as measure of working memory.
Time Frame
At enrollment
Title
Mini International Neuropsychiatric Interview (MINI)
Description
MINI is a semi-structured diagnostic interview for adults validated in french (Lecrubier & al., 1997). Current and past symptoms of psychopathology are assessed in order to establish one or more diagnoses according to the DSM-5 criteria.
Time Frame
At enrollment
Title
ADHD Adult Scale Rating Scale (ASRS)
Description
ASRS is a self-questionnaire to assess presence and severity of ADHD symptoms in parents and is composed of 18 items on 0-3 point scale. Higher scores indicates more ADHD symptoms.
Time Frame
At enrollment
Title
Wenders Utah Rating Scale (WURS)
Description
WURS is a self-questionnaire completed by parent that allows to assess retrospectively the presence of attentional difficulties and hyperactivity signs in childhood. The french version included 25 items rated from 0 to 4 depending on the severity of the behavior. Higher scores indicate more difficulty.
Time Frame
At enrollment
Title
Relationship Scale Questionnaire (RSQ)
Description
RSQ is a self-questionnaire of 30 items destined to assess the attachment style of adult (Secure, Fearful, Preoccupied and Detached). The adult rates each item on Likert scale in 5 points according to what looks most like him.
Time Frame
At enrollment
Title
Beck Depression Inventory-II (BDI-II)
Description
BDI-II is a self-report to assess presence of depressive symptoms in parent and includes 21 items. Each item is rated on 0-3 scale. Higher scores indicate more depressive symptoms
Time Frame
At enrollment
Title
Children's Sleep Habit Questionnaire (CSHQ)
Description
CSHQ is questionnaire rated by parents and is composed of 35 items on 1-3 point scale. Higher scores indicates more sleep disorders.
Time Frame
At enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Wylock, Mr
Phone
+32 2 477 31 80
Email
jean-françois.wylock@huderf.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique Delvenne, MDPhD
Organizational Affiliation
Queen Fabiola Children's University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Universitaire Des Enfants Reine Fabiola
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François Wylock, Mr
Phone
+32 2 477 31 80
Email
jean-françois.wylock@huderf.be
First Name & Middle Initial & Last Name & Degree
Jean-François Wylock, Mr
Facility Name
Hôpital Erasme
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hichem Slama, PhD
Phone
+32 2 555 33 57
Email
Hichem.slama@erasme.ulb.ac.be
First Name & Middle Initial & Last Name & Degree
Hichem Slama, PhD
First Name & Middle Initial & Last Name & Degree
Jean-François Wylock, Mr

12. IPD Sharing Statement

Plan to Share IPD
No

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Contribution of Attachment and Educational Practices in the Expression of ADHD in School-aged Children

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