NCT03565250

Brief Summary

Context: Attention Deficit Hyperactivity Disorder (ADHD), a major public health issue, is a neurodevelopmental disorder characterized by disturbance of attention, pathological impulsivity and a variable level of psychomotor hyperactivity. In addition to medium-term repercussions such as school failure or family dysfunction, these children have difficulties in dealing with emotions, metacognition and self-awareness that have serious consequences for self-regulation and identity construction. Objective: To investigate identity building in children with ADHD and explore its links with the severity of the disorder and associated neuropsychological disturbances. Material and method: 20 childrens with ADHD and 20 controls will be recruited over a 24-month period. They will be administered the Damon and Hart's Self-Understanding Interview, exploring 7 identity domains: Physical, Active, Social, Psychological, Continuity, Agentivity, Distinction Self/Other. The severity of ADHD, neuropsychological functioning (attention, working memory, executive functions, long-term memory), self-esteem and internal/external attributive style (locus of control) will be assessed by validated scales. The overall level of identity development and in each dimension will be compared between patients and controls. Within patients, the correlations between level of identity development and the severity of ADHD will be explored, as well as with neuropsychological functioning, with statistical control of age. Assumptions: The investigators hypothesize that children with ADHD will exhibit a significantly lower level of identity development than controls, which will be positively correlated with neuropsychological functioning, and negatively correlated with the severity of ADHD.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

May 16, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

July 20, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 13, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

May 16, 2018

Last Update Submit

July 12, 2018

Conditions

Keywords

Attention Deficit Disorder with HyperactivitySelf conceptChildNeuropsychology

Outcome Measures

Primary Outcomes (1)

  • Identity building

    Self understanding interview (Damon ahd Hart): analysis and developmental characterization of the child's discourse on himself, Model distinguishes the two components of Self: * the me-self: aggregation of self-knowledge; * The I self: the Self-as-subject; the subjective component that performs the act of self-knowledge. to attest to identity development: * The average level of identity development for me-self as a whole is calculated by summing the total number of segments in each developmental level multiplied by his cardinal, all divided by the total number of segments * Breakdown of segments of speech in the 4 modal levels (superficial, self-centered, interactive, codified) for each of the identity dimensions of the component of me-self (Physics, Active, Social, Psychological, Continuity, Agentivity, Distinction Self / Other) , * The best developmental level for each dimension of the I-Self component 0 à 4

    baseline

Secondary Outcomes (7)

  • • Intensity score of ADHD

    baseline

  • Self esteem

    baseline

  • Causal style

    baseline

  • Global Assessment of Functioning Scale

    baseline

  • working memory

    baseline

  • +2 more secondary outcomes

Study Arms (2)

ADHD patients

EXPERIMENTAL

children aged 8-12 ans with ADHD

Other: self understanding interview

control

ACTIVE COMPARATOR

children aged 8-12 ans without ADHD

Other: self understanding interview

Interventions

semi-structured interview designed for assessment of identity according to Damon \& Hart's 7-dimension develomental model

ADHD patientscontrol

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patient group:
  • Child aged 8 to 12,
  • clinical diagnosis of ADHD according to DSM-V criteria
  • Informed consent signed by the holder (s) of the exercise of parental authority and specifying the decision of the child himself,
  • Subject having French as mother tongue,
  • Subject affiliated to the social security system.
  • Control group:
  • Child aged 8 to 12,
  • Not suffering from ADHD according to DSM-V criteria
  • Informed consent signed by the holder (s) of the exercise of parental authority and specifying the decision the child himself,
  • Subjects with French as their mother tongue,
  • Subject affiliated to the social security system.

You may not qualify if:

  • Sensory disorders,
  • Pathology of the brain (head trauma, epilepsy, others),
  • Major psychiatric comorbidity (current depressive episode, schizophrenia, bipolar disorder, autism spectrum disorders),
  • Anticonvulsant treatment
  • Consumption of toxic (drug, alcohol).
  • Mental retardation QI less than 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, France

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Marie-Amélie Tordjman-Madigand, MD

    CHU CAEN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Amélie Tordjman-Madigand

CONTACT

Fabian Guenole

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 16, 2018

First Posted

June 21, 2018

Study Start

July 20, 2018

Primary Completion

August 4, 2020

Study Completion

December 31, 2020

Last Updated

July 13, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations