Attention Deficit Hyperactivity DisorderCASPI-ADHDNCT04337125
Contribution of Attachment and Educational Practices in the Expression of ADHD in School-aged Children
A study testing Neuropsychological and attachment/parenting assessment in people with Attention Deficit Hyperactivity Disorder, run by Queen Fabiola Children's University Hospital at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Neuropsychological and attachment/parenting assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesBelgium
- Study dates
- 15 May 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children with intellectual disabilities (IQ <80). Epilepsy. Prematurity. Objectified neurological sequelae. Specific language impairment or severe learning disabilities. Contraindication to stopping treatment for ADHD
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, 1020
Jean-François Wylock, Mr, +32 2 477 31 80, jean-françois.wylock@huderf.be
Jean-François Wylock, Mr
- Recruiting
Hôpital Erasme
Brussels, 1070
Hichem Slama, PhD, +32 2 555 33 57, Hichem.slama@erasme.ulb.ac.be
Hichem Slama, PhD
About this study
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
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.
Read more
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Neuropsychological and attachment/parenting assessment
- Keywords
- child, attachment, parenting, ADHD, executive functions
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological and attachment/parenting assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ADHD group | Other | ADHD children with their parents Receives: Other: Neuropsychological and attachment/parenting assessment |
| Control group | Other | Children with typical development and their parents Receives: Other: Neuropsychological and attachment/parenting assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: At enrollment
Secondary outcomes (21)
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
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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
Measured: At enrollment
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
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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.
Measured: At enrollment
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
Measured: At enrollment
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start15 May 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Belgian Kids' Fund
- Responsible party
- Sponsor
- Investigators
- Véronique Delvenne, MDPhD, Study director, Queen Fabiola Children's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337125
- Sponsor's protocol ID
- P2020/PSY/CASPI-ADHD
- Acronym
- CASPI-ADHD
- Status last verified
- Jun 2020
- First submitted
- 1 Apr 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04337125
- Acronym / sponsor ID
- CASPI-ADHD / P2020/PSY/CASPI-ADHD
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- child, attachment, parenting, ADHD, executive functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Collaborators
- The Belgian Kids' Fund
- Study start
- 15 May 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD group | Other | Other: Neuropsychological and attachment/parenting assessmentADHD children with their parents |
| Control group | Other | Other: Neuropsychological and attachment/parenting assessmentChildren with typical development and their parents |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Children with intellectual disabilities (IQ <80). Epilepsy. Prematurity. Objectified neurological sequelae. Specific language impairment or severe learning disabilities. Contraindication to stopping treatment for ADHD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological and attachment/parenting assessmentChildren 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. | Other | ADHD group, Control group |
Primary outcome
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.
21 secondary outcomes
Parent Education Practices Assessment Questionnaire (PEP)
Time frame: At enrollment
Parent Educational Practices perceived by the child (PEPPE)
Time frame: At enrollment
Behavioral Rating Inventory Executive Function (BRIEF)
Time frame: At enrollment
Behavioral Rating Inventory Executive Function for Adult (BRIEF-A)
Time frame: At enrollment
Test of Attentional Performance (TAP)
Time frame: At enrollment
Stroop
Time frame: At enrollment
Counting Stroop Task
Time frame: At enrollment
Tower of London
Time frame: At enrollment
Attention Deficit Hyperactivity Disorder-Rating Scale (ADHD-RS)
Time frame: At enrollment
Emotional Regulation Checklist - version française (ERC-vf)
Time frame: At enrollment
Children Behavior Checklist (CBCL)
Time frame: At enrollment
Revised Card Sorting Test (RCST)
Time frame: At enrollment
Kiddie-SADS-PL
Time frame: At enrollment
Wechsler Intelligence Scale for Children 5th edition (WISC-V)
Time frame: At enrollment
Wechsler Adult Intelligence Scale 4th edition (WAIS-IV)
Time frame: At enrollment
Mini International Neuropsychiatric Interview (MINI)
Time frame: At enrollment
ADHD Adult Scale Rating Scale (ASRS)
Time frame: At enrollment
Wenders Utah Rating Scale (WURS)
Time frame: At enrollment
Relationship Scale Questionnaire (RSQ)
Time frame: At enrollment
Beck Depression Inventory-II (BDI-II)
Time frame: At enrollment
Children's Sleep Habit Questionnaire (CSHQ)
Time frame: At enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: No
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Véronique Delvenne, MDPhD study director
Queen Fabiola Children's University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological and attachment/parenting assessment in people with Attention Deficit Hyperactivity Disorder, run by Queen Fabiola Children's University Hospital at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Wylock, Mr (+32 2 477 31 80, jean-françois.wylock@huderf.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cartes pour l'évaluation de l'Attachement et de la Mentalisation chez l'Enfant (CAME) (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.