NCT05096975

Brief Summary

Attention Deficit Hyperactivity Disorder (ADHD) is frequently associated with emotional dysregulation (ED). ED is characterized by excessive and inappropriate emotional reactions compared to social norms, uncontrolled and rapide shifts in emotion and attention focused on emotional stimuli. According to research, there are strong correlations between personality traits and psychiatric disorder as ADHD. In a longitudinal study, the persistence of ADHD symptoms during adolescence is associated with high neuroticism, low agreeableness and low conscience. Studies show that these personality traits are factors of vulnerabilities for comordities associated with ADHD and are predictive of overall functioning difficulties. Studies show correlations between ADHD in childhood and personality disorders at adulthood . ADHD is frequently associated with emotional dysregulation (ED) that is characterized by an inability to modulate emotional responses in a given context . ED is observed in 24% to 50% children with ADHD . Children with ADHD and ED are more likely to present a severe and complex symptomatology and are at risk for antisocial and bordeline personality disorders than children without ED. To date, there would be no studies which would have been interested in personality traits in children with ADHD and ED. The main objective is to determine if children with ADHD and ED present from childhood traits of personality as low agreeableness, low conscience and high neuroticism that are predictive of personality disorders at adulthood. It would involve earl identification of children at increased risk of pejorative developmental trajectories. The second objectives are:

  • Improve understanding of the heterogeneity of ADHD symptom expression;
  • Have a better understanding of the child's personalit and temperament traits to identify riks and protective factors;
  • Identify children with ADHD with profiles at risk of personality disorders in order to adapt the care according to the child's needs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

October 18, 2021

Last Update Submit

April 13, 2022

Conditions

Keywords

Personality traitsChildrenAttention Deficit Hyperactivity DisorderEmotion dysregulation

Outcome Measures

Primary Outcomes (1)

  • Rate of Score at the CBCL-A-A-A

    Score at the CBCL-A-A-A when combining the "Aggressive behaviors", "Anxiety/Depression" and "Attention" subscales (Achenbach \& Rescorla, 2001). Questionnaire measures emotional and behavior problem in 4 to 18 year-old children in the past months.

    1 day

Secondary Outcomes (1)

  • Rate of Score of Hierachical Personality Inventory for Childen

    1 day

Study Arms (3)

Control group

ADHD without emotion dysregulation (Control group) The group is composed of children with ADHD and with a score ≤ 180 at the CBCL-A-A-A when combining the "Aggressive behaviors", "Anxiety/Depression" and "Attention" subscales.

Other: Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without ED

Deficit Emotion Self Regulation group

ADHD without moderate emotion dysregulation (Deficit Emotion Self Regulation group) The group is composed of children with ADHD and with a score ≥180 and ≤ 210 at the CBCL-A-A-A when combining the "Aggressive behaviors", "Anxiety/Depression" and "Attention" subscales.

Other: Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without ED

Dysregulation Profile Group

ADHD with severe emotion dysregulation (Dysregulation Profile Group) The group is composed of children with ADHD and with a score ≥ 210 at the CBCL-A-A-A when combining the "Aggressive behaviors", "Anxiety/Depression" and "Attention" subscales.

Other: Evaluation of the CBCL-A-A-A and HiPIC in children with ADHD and with ED or without ED

Interventions

The intervention involves the completion of two questionnaires by parents at child psychiatry unit of Montpellier University Hospital when children come to participate in a psychometric assessment or when parents or children participate in therapeutic group. All parents completed Child Behavior Checklist (CBCL; Achenbach \& Rescorla, 2001), a 118-item questionnaire to measure emotional and behavior problems in 4 to 18-years-old children in the past six months and Hierarchical Personality Inventory for Children (HiPIC, Mervielde \& De Fruyt, 1999, a 144-item questionnaire to obtain a profile of the personality of 6 to 12-year-old children.

Control groupDeficit Emotion Self Regulation groupDysregulation Profile Group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

* Children with a diagnostic of ADHD and followed at Montpellier University Hospital. * Children and adolescents aged between 7 and 12 years.

You may qualify if:

  • Children and adolescents aged 7-12 years followed at Montpellier University Hospital ;
  • Children and adolescents with a diagnostic of ADHD (diagnostics criteria from DSM-V);
  • Children and adolescents benefiting from a multidisciplinary evaluation or therapeutic group at the child psychiatry unit of Montpellier University Hospital

You may not qualify if:

  • \- Family non-french speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: NONE RETAINED

NC

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Diane Purper-Ouakil, M.D., Ph. D.

    UH Montpellier

    STUDY DIRECTOR
  • Romo, PHD

    University Paris Nanterre

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2021

First Posted

October 27, 2021

Study Start

September 1, 2020

Primary Completion

September 30, 2021

Study Completion

December 30, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations