ClinicalTrials.gg
CompletedNCT03447535TOPiUpdated Feb 27, 2018

Better Understand Children and Adolescents' Intrafamilial Oppositional Defiant Disorder

An observational study in Oppositional Defiant Disorder With Familial Setting, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 5 Years to 16 Years. Per ClinicalTrials.gov, last updated 2018-02-27.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
75
Ages
5 Years to 16 Years
Sex
All
01

Study summary

Oppositional Defiant Disorder (ODD) is defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) as: "A pattern of angry/irritable mood, argumentative/defiant behavior, or vindictiveness lasting at least 6 months exhibited during interaction with at least one individual who is not a sibling." "The disturbance in behavior is associated with distress in the individual or others in his or her immediate social context (e.g., family, peer group, work colleagues), or it impacts negatively on social, educational, occupational, or other important areas of functioning." Children with "classic" oppositional defiant disorder, except for mild forms, show symptoms in several settings (at home, at school, with peers).

In this study, the investigators will consider the specifics of children presenting "intrafamilial" oppositional defiant disorder (IODD). These children's symptoms are confined to only one setting: the home. Therefore, the aim of this study will be to characterize children with intrafamilial oppositional defiant disorder. The investigators want to understand the differences between IODD and classical forms of ODD in terms of psychiatric comorbidities, medical histories and cognitive abilities. They also investigate what clinicians currently do to help these families.

Read the detailed description

Definition: Extended description of the protocol, including more technical information (as compared to the Brief Summary), if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as Eligibility Criteria or outcome measures.

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Child-to-parent violence was kept secret for a long time. Searchers don't know much about this type of domestic violence, however they recently tried to investigate more on the subject. Bousquet et al. carried out a review of literature on the subject, and grouped the articles that they found. There was only one study concerned with children with Intrafamilial Oppositional Defiant Disorder (IODD) which is called in the study Oppositional Defiant Disorder with family tyranny (Delaunay et al., 2008).

IODD is described in the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM) as a mild form of Oppositional Defiant Disorder (ODD). This term characterizes children that meet the criteria for ODD ("a pattern of angry/irritable mood, argumentative/defiant behavior, or vindictiveness") but their symptoms are confined to only one setting: the home. Therefore, the aim of this study is to characterize Intrafamilial ODD children and the particularities of their families.

Nowadays, new treatment strategies exist in Montpellier, designed to be used as group therapies. In these groups, non-violent resistance methods are taught to the parents. The efficiency of this therapy is currently being studied. To improve this therapy and to offer appropriate therapies to the children themselves, it is important to improve the acknowledgement of these "tyrannical children". This is the aim of this study. To reach this goal, the investigators will compare the medical records of the children with IODD to those of the children with classic ODD.

On one hand, they expect children with IODD to be more anxious and smarter than children with "classic" ODD. On the other hand, they expect they will have had diseases that changed interactions with their parents. They also assume they will come from small families: i.e. they may be an only child, educated by a single parent, or they may have wealthy parents. Finally, they hypothesize that clinicians won't treat the children with IODD the same way as those with "classic" ODD.

02

Conditions studied

  • Oppositional Defiant Disorder With Familial Setting

Keywords

  • Oppositional defiant disorder
  • Family
  • Disruptive, impulse control and conduct disorders
  • Anxiety disorder
  • Intrafamilial disruptive behaviours disorder
03

In context

Oppositional Defiant Disorder

86 studies on the registry are indexed under Oppositional Defiant Disorder; 16 are open to participants now.

This study's enrollment of 75 is below the median of 200 across 10 observational studies indexed under Oppositional Defiant Disorder.

Browse Oppositional Defiant Disorder studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects include:

  • Patients diagnosed with ODD during a day evaluation at one of our unit cares: UDS (Unité de Diagnostic et de Soins) or UPP (Unité de Prévention Pédosychiatrique); both units are headed by the Pr Diane Purper-Ouakil CHU Saint Eloi Montpellier.
  • Patients included in the " REACT " study conducted at CHU Saint Eloi Montpellier, and diagnosed with ODD during the pre-study visit.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Child diagnosed with ODD with KSADS_PL
  • Child who was evaluated during a day evaluation at one of our unit cares: UDS (Unité de Diagnostic et de Soins) or UPP (Unité de Prévention Pédosychiatrique)
  • Child included in the "REACT" study
  • 16 years old or under

Exclusion criteria

Exclusion criteria:

  • Child who has not been diagnosed with ODD
  • Missing data in the parent report SDQ or teacher report SDQ preventing the SDQ total score calculation
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
75 participants (actual)
Patient registry
No

Groups and cohorts

  • classic oppositional defiant disorder

    CODD Group: " classic " oppositional defiant disorder SDQ total difficulties score and the parents report SDQ total difficulties score: Group CODD (" classic " oppositional defiant disorder): teacher report SDQ total difficulties score (≥ 12), parents report SDQ total difficulties score (≥14)

    Other: Semi-directive interview (Kiddy Sads) · Other: SDQ questionnaires (strenghs and difficulties questionnaire)

  • intrafamilial oppositional defiant disorder

    IODD group: intrafamilial oppositional defiant disorder SDQ total difficulties score and the parents report SDQ total difficulties score: Group IODD (Intrafamilial Oppositional Defiant Disorder): teacher report SDQ total difficulties score normal (\<12), parents report SDQ total difficulties score abnormal (\>16)

    Other: Semi-directive interview (Kiddy Sads) · Other: SDQ questionnaires (strenghs and difficulties questionnaire)

Interventions

  • OtherSemi-directive interview (Kiddy Sads)

    semi-directive interview (Kiddy Sads) conducted as part of the care

  • OtherSDQ questionnaires (strenghs and difficulties questionnaire)

    SDQ questionnaires (strenghs and difficulties questionnaire) conducted as part of the care

06

What researchers measure

Primary outcomes

  1. Measure of the prevalence of the anxiety disorder diagnosis

    The psychometric test used to characterize the specific primary outcome measure is the Kiddie-SADS-PL Schedule For Affective Disorders and Schizophrenia for School Age Children Present and Lifetime Version. The K-SADS-PL is a semi-structured interview aimed at early diagnosis of affective disorders such as anxiety disorder, depression, bipolar disorder. It generates reliable and valid child psychiatric diagnoses (1). It is specifically designed for school children aged 6 to 18. In this study, the K-SADS-PL test is performed by psychiatry residents or by psychologists. The interview is performed during the evaluation day (hospital day care) or during the pre-study visit for patients participating in the " react " protocole.

    Time frame: 1 day

Secondary outcomes

  1. Measure of Intellectual qQuotient

    The Wechsler Intelligence Scale for Children (WISC) is an individually administered intelligence test for children aged 6 to 16. The test generates a Full Scale IQ (formerly known as an intelligence quotient or IQ score) that represents a child's general intellectual ability. In our study, both WISC IV and WISC V have been used. The Fifth Edition is the most current version, and has therefore been used for the most recent tests. The WISC IV provides four index scores: Verbal Comprehension Index, Processing speed Index,Working Memory Index, Perceptual Reasoning Index (see below). The WISC V provides 5 index scores: Verbal Comprehension Index, Visual Spatial Index, Fluid Reasoning Index, Working Memory Index, and Processing Speed Index (see below). For the measure of the intellectual quotient and for the measure of all the index scores, the average is 80-120. Bellow average values represents poorer outcome.

    Time frame: 1 day

Other outcomes

  1. Assesment of Verbal Comprehension Index

    The Verbal Comprehension Index (VCI) is a score derived from the administration of selected subtests from the fourth and the fifth Wechsler Intelligence Scale for Children (WISC). It is designed to provide a measure of verbal acquired knowledge and verbal reasoning. (See Encyclopedia of Clinical Neuropsychology)

    Time frame: 1 day

  2. Perceptual Reasoning Index

    The WISC IV provides four index scores: Verbal Comprehension Index, Processing speed Index,Working Memory Index, Perceptual Reasoning Index. The WISC V provides 5 index scores: Verbal Comprehension Index, Visual Spatial Index, Fluid Reasoning Index, Working Memory Index, and Processing Speed Index.

    Time frame: 1 day

  3. Working Memory Index

    The WISC IV provides four index scores: Verbal Comprehension Index, Processing speed Index,Working Memory Index, Perceptual Reasoning Index. The WISC V provides 5 index scores: Verbal Comprehension Index, Visual Spatial Index, Fluid Reasoning Index, Working Memory Index, and Processing Speed Index.

    Time frame: 1 day

  4. Processing Speed Index

    The WISC IV provides four index scores: Verbal Comprehension Index, Processing speed Index,Working Memory Index, Perceptual Reasoning Index. The WISC V provides 5 index scores: Verbal Comprehension Index, Visual Spatial Index, Fluid Reasoning Index, Working Memory Index, and Processing Speed Index.

    Time frame: 1 day

  5. Visuo Spatial Index

    The WISC IV provides four index scores: Verbal Comprehension Index, Processing speed Index,Working Memory Index, Perceptual Reasoning Index. The WISC V provides 5 index scores: Verbal Comprehension Index, Visual Spatial Index, Fluid Reasoning Index, Working Memory Index, and Processing Speed Index.

    Time frame: 1 day

  6. Fluid Reasoning Index (FRI)

    It is a score derived from the administration of selected subtests from the fifth Wechsler Intelligence Scale for Children (WISC). It allows to detect underlying conceptual relationships among visual objects

    Time frame: 1 day

  7. Prevalence of somatic diseases in patient medical history

    Past somatic diseases were mentioned in the patient medical record. We classified them into: 1. Serious illness (chronic illness, hospitalisation needed, treatment taken for several months) 2. Less serious illness.

    Time frame: 1 day

  8. Socio-economic status of the family assessed by parents' occupation

    Parents' occupation were classified into 6 categories derived from the INSEE classification (Institut national de la statistique et des études économiques)

    Time frame: 1 day

  9. Family situation

    Family situation: number of siblings, birth rank among siblings, single parents, divorced parents Description:This information is in the medical reports, it is mentioned in the questionnaire that is always filled by parents before the first consultation of their child.

    Time frame: 1 day

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
08

References and documents

Individual participant data

Plan to share: Undecided — NC

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Dec 2017, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2018
First posted
Feb 27, 2018
StartActual
Dec 1, 2017
Primary completionActual
Dec 31, 2017
CompletionActual
Dec 31, 2017
Last update
Feb 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03447535
Responsible party
Sponsor
First posted
Feb 27, 2018
Start date
Dec 1, 2017
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Feb 27, 2018

Study contacts

Elisa BOUSQUET
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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