Oppositional Defiant Disorder With Familial SettingTOPiNCT03447535
Better Understand Children and Adolescents' Intrafamilial Oppositional Defiant Disorder
An observational study of Oppositional Defiant Disorder With Familial Setting, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Oppositional Defiant Disorder With Familial Setting
- What is being tested?
- Semi-directive interview (Kiddy Sads) and SDQ questionnaires (strenghs and difficulties questionnaire)
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2017to 31 Dec 2017
- Phase
- Observational
- 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 5 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on Intrafamilial Oppositional Defiant Disorder (IODD) in Children and Adolescents
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.
Limit: 32,000 characters.
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.
- Being tested
- Semi-directive interview (Kiddy Sads), SDQ questionnaires (strenghs and difficulties questionnaire)
- Keywords
- Oppositional defiant disorder, Family, Disruptive, impulse control and conduct disorders, Anxiety disorder, Intrafamilial disruptive behaviours disorder
- Medical subject headings
- Oppositional Defiant Disorder, Disruptive, Impulse Control, and Conduct Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-directive interview (Kiddy Sads)Other
semi-directive interview (Kiddy Sads) conducted as part of the care
SDQ questionnaires (strenghs and difficulties questionnaire)Other
SDQ questionnaires (strenghs and difficulties questionnaire) conducted as part of the care
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Semi-directive interview (Kiddy Sads); Other: SDQ questionnaires (strenghs and difficulties questionnaire) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Dec 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oppositional Defiant Disorder With Familial SettingStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisa BOUSQUET, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447535
- Sponsor's protocol ID
- RECHMPL17_0443
- Acronym
- TOPi
- Status last verified
- Feb 2018
- First submitted
- 2 Feb 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Intrafamilial Oppositional Defiant Disorder (IODD) in Children and Adolescents
- ClinicalTrials.gov ID
- NCT03447535
- Acronym / sponsor ID
- TOPi / RECHMPL17_0443
- Keywords
- Oppositional defiant disorder, Family, Disruptive, impulse control and conduct disorders, Anxiety disorder, Intrafamilial disruptive behaviours disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 27 Feb 2018 (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.
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.
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.
Limit: 32,000 characters.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| classic oppositional defiant disorder | – | Other: Semi-directive interview (Kiddy Sads), Other: SDQ questionnaires (strenghs and difficulties questionnaire)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) |
| intrafamilial oppositional defiant disorder | – | Other: Semi-directive interview (Kiddy Sads), Other: SDQ questionnaires (strenghs and difficulties questionnaire)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) |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Semi-directive interview (Kiddy Sads)semi-directive interview (Kiddy Sads) conducted as part of the care | Other | classic oppositional defiant disorder, intrafamilial oppositional defiant disorder |
| SDQ questionnaires (strenghs and difficulties questionnaire)SDQ questionnaires (strenghs and difficulties questionnaire) conducted as part of the care | Other | classic oppositional defiant disorder, intrafamilial oppositional defiant disorder |
Primary outcome
Measure of the prevalence of the anxiety disorder diagnosis
Time frame: 1 day
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.
1 secondary outcome
Measure of Intellectual qQuotient
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
- Individual participant dataSharing planned: Undecided. NC
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.
Elisa BOUSQUET principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oppositional Defiant Disorder With Familial Setting, run by University Hospital, Montpellier at 1 site in France.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the prevalence of the anxiety disorder diagnosis (time frame: 1 day). 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 27 Feb 2018.