Oppositional Defiant DisorderNCT06194994
Emotion Regulation as a Moderator of Two Different Treatments for Children With ODD
A study testing Parent Management Training and Tuning Your Temper in people with Oppositional Defiant Disorder, run by University of Iceland at 1 site in Iceland.
Trial summary
The goal of this randomized controlled trial is to is to test emotion regulation as a moderator of two different treatments for children with Oppositional Defiant Disorder (ODD). Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Oppositional Defiant Disorder
- What is being tested?
- Parent Management Training and Tuning Your Temper
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteIceland
- Study dates
- 4 Jan 2024to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosed with Oppositional Defiant Disorder
- Icelandic speaking (child and parent/guardian)
Who cannot join
- IQ below 70 (full scale score)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iceland1 site, 1 recruiting
- Recruiting
University of Iceland
Reykjavik, 101
Urdur Njardvik, PhD, +3545255957, urdurn@hi.is
About this study
Official title: Emotion Regulation as a Moderator of Two Different Treatments for Children With Oppositional Defiant Disorder: A Randomized Clinical Trial
The goal of this randomized controlled trial is to is to test emotion regulation as a moderator of two different treatments for children with Oppositional Defiant Disorder (ODD). The main question it aims to answer is whether treatment gains be increased when children with ODD receive a treatment congruent with their emotion regulation skill problems. Participants will be divided into two groups based on their response patterns; a high emotion dysregulation group and a low emotion dysregulation group. Within each group, children will then be randomly assigned to either a behavioral parent training intervention or a child directed treatment involving problem solving and emotion regulation skills.
Read the detailed description
Emotion regulation has been implicated in the development of ODD. Two types of treatment are commonly used for children with ODD, behavioral parent training and child directed cognitive treatments. Parent training focuses on increasing compliance and reducing defiant behaviour while the child directed treatments focus on increasing the child's problem solving skills and emotion regulation. The investigators will assess emotion regulation and emotional lability in children diagnosed with ODD and divide them into two groups based on their response patterns; a high emotion dysregulation group and a low emotion dysregulation group. Within each group, children will then be randomly assigned to either a behavioral parent training intervention or a child directed treatment involving problem solving and emotion regulation skills, which makes it possible to assess the effects of the different interventions for the two distinct groups. Treatment effects will be assessed at pre- and post-treatment as well as at 6 and 18 month follow-up. Comorbid conditions will be tested as moderators.
- Conditions
- Oppositional Defiant Disorder
- Being tested
- Parent Management Training, Tuning Your Temper
- Keywords
- Oppositional Defiant Disorder, Emotion Regulation, Child Psychopathology
- Medical subject headings
- Oppositional Defiant Disorder, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent Management TrainingBehavioural
Behavioral parent training program aimed at increasing compliance and positive behaviours while decreasing disruptive behaviours
Tuning Your TemperBehavioural
Cognitive behavioural treatment for children focusing on arousal reduction, problem solving and cognitive restructuring.
| Study group | Role | What they receive |
|---|---|---|
| Parent Training | Experimental | Behavioral parent training intervention. Individual sessions. Receives: Behavioral: Parent Management Training |
| Child directed treatment | Experimental | Child directed cognitive behavioral therapy. Individual sessions. Receives: Behavioral: Tuning Your Temper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disruptive Behaviour Rating Scale
Parent and teacher rated questionnaire to assess change in symptoms of ODD.
Measured: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
Diagnostic Interview to assess whether a child changes in diagnostic status, whether child meets DSM-5 diagnostic criteria for mental disorders.
Measured: Pre-treatment; 6-month follow-up; 18-month follow-up.
Secondary outcomes (5)
Strength and difficulties questionnaire
Parent and teacher rated questionnaire to assess change in emotional and behavioral problems. Results are converted to t-scores where t=65 is considered a clinical cut-off score. Higher scores indicate worse outcome.
Measured: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Home Situations Questionnaire
Parent rated questionnaire to assess change in compliance and problematic behaviour at home. Frequency of problems is recorded (min 0, max 16) and severity score for each item endorsed is rated on the scale of 0-9 with higher scores indicating worse outcome.
Measured: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Social Skills Rating System
Parent rated questionnaire to assess change in social skills. The SSRS has 55 questions rated from 0-2 (min 0 max 110). There are 4 social skills domains: Cooperation, Assertion, Responsibility and Self-control with higher scores indicating better outcome. And 3 problem domains (External, Internal and Hyperactivity) with higher scores indicating worse outcome.
Measured: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Parent Stress Index
Parent rated questionnaire to assess change in parental stress. Scores range from 18-90 with higher scores indicating higher levels of parental stress.
Measured: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Pediatric Quality of Life Index
Questionnaire to assess change in child quality of life. The parent version used has 23 items rated on a scale from 0-4 (min 0 max 92). High scores indicate worse outcome.
Measured: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start4 Jan 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oppositional Defiant 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation to two different treatments which will be compared.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Collaborators
- Stockholm University
- Responsible party
- Principal investigator, Urdur Njardvik, University of Iceland
- Investigators
- Urdur Njardvik, PhD, Principal investigator, Department of Psychology, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194994
- Sponsor's protocol ID
- UI-2023-ODDEMREG
- Status last verified
- Jan 2024
- First submitted
- 22 Jun 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the study includes repeated measures of a vulnerable population, parts of the data will be classified as sensitive personal data and thus restricted by the permit from the Bioethics Committee. We will consult with GAGNÍS (member of CESSDA ERIC) on how to make the data available according to the FAIR principles.
Publications
Njardvik U, Smaradottir H, Ost LG. The Effects of Emotion Regulation Treatment on Disruptive Behavior Problems in Children: A Randomized Controlled Trial. Res Child Adolesc Psychopathol. 2022 Jul;50(7):895-905. doi: 10.1007/s10802-022-00903-7. Epub 2022 Feb 8.
PubMed 35133557Barkley, R. A. (2013). Defiant children: A clinician's manual for assessment and parent training: Guilford press
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Regulation as a Moderator of Two Different Treatments for Children With Oppositional Defiant Disorder: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06194994
- Acronym / sponsor ID
- UI-2023-ODDEMREG
- Conditions
- Oppositional Defiant Disorder
- Keywords
- Oppositional Defiant Disorder, Emotion Regulation, Child Psychopathology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Collaborators
- Stockholm University
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 8 Jan 2024 (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.
The goal of this randomized controlled trial is to is to test emotion regulation as a moderator of two different treatments for children with Oppositional Defiant Disorder (ODD). The main question it aims to answer is whether treatment gains be increased when children with ODD receive a treatment congruent with their emotion regulation skill problems. Participants will be divided into two groups based on their response patterns; a high emotion dysregulation group and a low emotion dysregulation group. Within each group, children will then be randomly assigned to either a behavioral parent training intervention or a child directed treatment involving problem solving and emotion regulation skills.
Detailed description
Emotion regulation has been implicated in the development of ODD. Two types of treatment are commonly used for children with ODD, behavioral parent training and child directed cognitive treatments. Parent training focuses on increasing compliance and reducing defiant behaviour while the child directed treatments focus on increasing the child's problem solving skills and emotion regulation. The investigators will assess emotion regulation and emotional lability in children diagnosed with ODD and divide them into two groups based on their response patterns; a high emotion dysregulation group and a low emotion dysregulation group. Within each group, children will then be randomly assigned to either a behavioral parent training intervention or a child directed treatment involving problem solving and emotion regulation skills, which makes it possible to assess the effects of the different interventions for the two distinct groups. Treatment effects will be assessed at pre- and post-treatment as well as at 6 and 18 month follow-up. Comorbid conditions will be tested as moderators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomisation to two different treatments which will be compared.
| Arm | Type | Receives |
|---|---|---|
| Parent Training | Experimental | Behavioral: Parent Management TrainingBehavioral parent training intervention. Individual sessions. |
| Child directed treatment | Experimental | Behavioral: Tuning Your TemperChild directed cognitive behavioral therapy. Individual sessions. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosed with Oppositional Defiant Disorder
- Icelandic speaking (child and parent/guardian)
Key exclusion criteria (1 listed)
- IQ below 70 (full scale score)
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 |
|---|---|---|
| Parent Management TrainingBehavioral parent training program aimed at increasing compliance and positive behaviours while decreasing disruptive behaviours | Behavioural | Parent Training |
| Tuning Your TemperCognitive behavioural treatment for children focusing on arousal reduction, problem solving and cognitive restructuring. | Behavioural | Child directed treatment |
Primary outcome
Disruptive Behaviour Rating Scale
Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Parent and teacher rated questionnaire to assess change in symptoms of ODD.
Schedule for Affective Disorders and Schizophrenia for School Aged Children (K-SADS-PL)
Time frame: Pre-treatment; 6-month follow-up; 18-month follow-up.
Diagnostic Interview to assess whether a child changes in diagnostic status, whether child meets DSM-5 diagnostic criteria for mental disorders.
5 secondary outcomes
Strength and difficulties questionnaire
Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Home Situations Questionnaire
Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Social Skills Rating System
Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Parent Stress Index
Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Pediatric Quality of Life Index
Time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
- Background: PubMed 35133557Njardvik U, Smaradottir H, Ost LG. The Effects of Emotion Regulation Treatment on Disruptive Behavior Problems in Children: A Randomized Controlled Trial. Res Child Adolesc Psychopathol. 2022 Jul;50(7):895-905. doi: 10.1007/s10802-022-00903-7. Epub 2022 Feb 8.
- BackgroundBarkley, R. A. (2013). Defiant children: A clinician's manual for assessment and parent training: Guilford press
- Individual participant dataSharing planned: No. As the study includes repeated measures of a vulnerable population, parts of the data will be classified as sensitive personal data and thus restricted by the permit from the Bioethics Committee. We will consult with GAGNÍS (member of CESSDA ERIC) on how to make the data available according to the FAIR principles.
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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.
Urdur Njardvik, PhD principal investigator
Department of Psychology, University of Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Management Training and Tuning Your Temper in people with Oppositional Defiant Disorder, run by University of Iceland at 1 site in Iceland.
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: looking for participants now, as of the sponsor's last update on 8 Jan 2024. 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 Iceland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Urdur Njardvik, PhD (+354-525-5957, urdurn@hi.is), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disruptive Behaviour Rating Scale (time frame: Pre-treatment; Immediately post-treatment; 6-month follow-up; 18-month follow-up.). 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?
On the ClinicalTrials.gov record for NCT06194994, which also lists 2 linked publications.
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 8 Jan 2024.