Disruptive Behavior DisorderNCT03698240
Mindfulness-based Program for Children With Disruptive Behavior Disorder
A study testing Mindfulness-based program in people with Disruptive Behavior Disorder and Oppositional Defiant Disorder, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
Trial summary
The present RCT study investigates whether combined mindfulness program for children and their parents was beneficial for Italian children, aged 8-12, with disruptive behavior diagnosis (DBD). Read more about this study
- Who is it for?
- Ages 8 to 12 years, men only
- Conditions the study is for
- Disruptive Behavior Disorder, Oppositional Defiant Disorder, Attention Deficit and Disruptive Behavior Disorders
- What is being tested?
- Mindfulness-based program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 4 Oct 2018to 1 Jun 2020
- Phase
- Interventional
- 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 8 to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Disruptive Behavior primary diagnosis
Who cannot join
- IQ < 80
- ASD diagnosis
- ongoing other interventions
Trial locations and contacts
1 site in 1 country.
About this study
The present RCT study investigates whether combined mindfulness program for children and their parents was beneficial for Italian children, aged 8-12, with disruptive behavior diagnosis (DBD). The study tests the program effects on children's behavioral difficulties in school and home contexts; children's and parents' mindfulness abilities; children's impulsiveness; and parents' stress. The study include a sample of 50 children randomly allocate to the intervention or to the control condition (wait-list control sample). Repeated measures of children's and parents' and teachers' reported measures will be used.
- Conditions
- Disruptive Behavior Disorder, Oppositional Defiant Disorder, Attention Deficit and Disruptive Behavior Disorders
- Being tested
- Mindfulness-based program
- Keywords
- Mindfulness, ADHD, Oppositional Defiant Disorder
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders, Oppositional Defiant Disorder, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based programBehavioural
Also called Fiore dentro
The program includes 9 mindfulness-based sessions for children and their parents.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based program | Experimental | Children and parents receive the program Receives: Behavioral: Mindfulness-based program |
| Waiting-list | No intervention | Children and parents receive no-interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in behavioral problems at school
Strengths and Difficulties Questionnaire Strength and Difficulties Questionnaire (SDQ) is one of the most frequently used behavioral rating scale in educational, research, and clinical settings for assessing emotional and behavioral patterns in childhood. This 25-item questionnaire measures psychological adjustment in 3- to 16-year-olds in five subdomains. Of these, four subscales measure difficulties (conduct problems, hyperactivity, emotional problems, and peer relational problems), while the fifth measures strengths (prosocial behavior). There are three versions of the scale (a parent, teacher, and self-report).
Measured: One week before the start of the intervention, one week after the end of the intervention.
Change in Aggressive behaviors
Modified Overt Aggression Scale The MOAS (Kay et al., 1988) is a clinician administered scale that measures four types of overt aggression over the past week: verbal aggression, physical aggression against property, auto-aggression, and physical aggression against other people.
Measured: One week before the start of the intervention, one week after the end of the intervention.
Change in Behavioral problems at home
Child Behavior Check List It is a 118 item standardized format, completed by parents for recording behavioural problems and skills in children 6 to 18 years of age. The 118 behaviour problem items are aggregated in eight different subscales related to both Internalizing and Externalizing domains.
Measured: One week before the start of the intervention, one week after the end of the intervention.
Change in impulsiveness
Matching Familiar (MF-20) test from Italian Battery for ADHD (Marzocchi, Re, \& Cornoldi, 2010). In the Matching Familiar Figures (MF) test, participants are shown a figure and are asked to find the matching one among six choices. This task measures the children's impulsiveness. The MF test includes 20 items. Clinicians sum children's score in accuracy and latency time to arrive at one reported value, that is the children's impulsiveness score.
Measured: One week before the start of the intervention, one week after the end of the intervention.
Change in sustained attention capacities
Bells Test Revised The Bells Test revised (Biancardi \& Stoppa, 1997) is a test for the evaluation of sustained attention in children. The test is an adaptation of Gauthiers's Bell Test used to assess neglect in adults. The Bells Test has been modified in order to make it suitable to research in developmental age. Items are organized in four different pages, which include each 35 bells. Speed and Accuracy in selecting the target stimuli (bells) are assessed. The Speed score refers to the number of bells found by the child in the first 30 seconds of the task, while the Accuracy score refers to the total number of bells found during the whole task (120 seconds).
Measured: One week before the start of the intervention, one week after the end of the intervention.
Secondary outcomes (5)
Change in children's mindfulness abilities
Child and Adolescent Mindfulness Measure The CAMM is a recently developed questionnaire that assesses present-moment awareness and non-judgmental, non-avoidant responses to thoughts and feelings in children and adolescents (i.e., "I keep myself busy so I don't notice my thoughts or feelings"), and the ten items are rated on a fivepoint scale. The CAMM has been shown to be reliable (α= 0.81), and positive correlations have been shown with quality of life, social skills, and academic performance. Negative correlations were shown with somatic complaints, internalizing, and externalizing symptoms (Greco et al. 2011).
Measured: One week before the start of the intervention, one week after the end of the intervention.
Change in parents' mindfulness abilities
Five Facet Mindfulness Questionnaire The FFMQ is a 39-item questionnaire that measures five facets of mindfulness (Baer et al., 2006): observing (8 items, e.g., I notice the smells and aromas of things), describing (8 items, e.g., I'm good at finding the words to describe my feelings), acting with awareness (8 items; e.g., I am easily distracted), nonjudging (8 items, e.g., I criticize myself for having irrational or inappropriate emotions), and nonreactivity (7 items; e.g., I watch my feelings without getting lost in them). Participants were asked to rate the degree to which each statement is true for them. Items were scored on a 5-point Likert-type scale ranging from 1 (never or very rarely true) to 5 (very often or always true). Facet scores were computed by summing the scores on the individual items. Facet scores range from 8 to 40 (except for the nonreactivity facet, which ranges from 7 to 35), with higher scores indicating more mindfulness.
Measured: One week before the start of the intervention, one week after the end of the intervention.
Change in children's anxiety traits
Multidimensional Anxiety Scale for Children The Multidimensional Anxiety Scale for Children (MASC) is a 39-item, 4-point Likert self-report scale that robustly represents the factor structure of anxiety in children aged 8 to 18 years. MASC main and subfactors include (a) physical symptoms (tense/restless and somatic/autonomic), (b) harm avoidance (anxious coping and perfectionism), (c) social anxiety (humiliation/rejection and public performance fears), and (d) separation anxiety.
Measured: One week before the start of the intervention, one week after the end of the intervention.
Change in parenting practices
Alabama Parenting Questionnaire The APQ is a 42-item measure on which parents were asked to indicate the frequency with which they implemented a range of parenting practices on a 5-point scale, ranging from 1 (never) to 5 (always). The subfactors include: a) positive parenting, b) parental involvement, c) inconsistent discipline, d) corporal punishment.
Measured: One week before the start of the intervention, one week after the end of the intervention.
Change in parents' stress
Parenting Stress Index The PSI-SF is a 36- item questionnaire designed to measure stress in the parent-child system and identify those families most in need of follow-up services. The PSI-SF consists of three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child. Each subscale consists of 12 items rated from 1 (strongly disagree) to 5 (strongly agree). Subscale scores therefore range from 12 to 60, whereas the total score ranges from 36 to 180. High scores on the subscales and PSI-SF total score indicate greater levels of stress.
Measured: One week before the start of the intervention, one week after the end of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start4 Oct 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive Behavior 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pisa
- Responsible party
- Sponsor
- Investigators
- Pietro Muratori, Principal investigator, IRCCS Stella Maris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698240
- Sponsor's protocol ID
- MIND-DBD
- Status last verified
- Jan 2019
- First submitted
- 20 Jun 2018
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Program for Children With Disruptive Behavior Disorder
- ClinicalTrials.gov ID
- NCT03698240
- Acronym / sponsor ID
- MIND-DBD
- Conditions
- Disruptive Behavior Disorder, Oppositional Defiant Disorder, Attention Deficit and Disruptive Behavior Disorders
- Keywords
- Mindfulness, ADHD, Oppositional Defiant Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- University of Pisa
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 5 Oct 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.
The present RCT study investigates whether combined mindfulness program for children and their parents was beneficial for Italian children, aged 8-12, with disruptive behavior diagnosis (DBD). The study tests the program effects on children's behavioral difficulties in school and home contexts; children's and parents' mindfulness abilities; children's impulsiveness; and parents' stress. The study include a sample of 50 children randomly allocate to the intervention or to the control condition (wait-list control sample). Repeated measures of children's and parents' and teachers' reported measures will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based program | Experimental | Behavioral: Mindfulness-based programChildren and parents receive the program |
| Waiting-list | No intervention | –Children and parents receive no-interventions. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Disruptive Behavior primary diagnosis
Key exclusion criteria (3 listed)
- IQ < 80
- ASD diagnosis
- ongoing other interventions
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 |
|---|---|---|
| Mindfulness-based programAlso: Fiore dentroThe program includes 9 mindfulness-based sessions for children and their parents. | Behavioural | Mindfulness-based program |
Primary outcome
Change in behavioral problems at school
Time frame: One week before the start of the intervention, one week after the end of the intervention.
Strengths and Difficulties Questionnaire Strength and Difficulties Questionnaire (SDQ) is one of the most frequently used behavioral rating scale in educational, research, and clinical settings for assessing emotional and behavioral patterns in childhood. This 25-item questionnaire measures psychological adjustment in 3- to 16-year-olds in five subdomains. Of these, four subscales measure difficulties (conduct problems, hyperactivity, emotional problems, and peer relational problems), while the fifth measures strengths (prosocial behavior). There are three versions of the scale (a parent, teacher, and self-report).
Change in Aggressive behaviors
Time frame: One week before the start of the intervention, one week after the end of the intervention.
Modified Overt Aggression Scale The MOAS (Kay et al., 1988) is a clinician administered scale that measures four types of overt aggression over the past week: verbal aggression, physical aggression against property, auto-aggression, and physical aggression against other people.
Change in Behavioral problems at home
Time frame: One week before the start of the intervention, one week after the end of the intervention.
Child Behavior Check List It is a 118 item standardized format, completed by parents for recording behavioural problems and skills in children 6 to 18 years of age. The 118 behaviour problem items are aggregated in eight different subscales related to both Internalizing and Externalizing domains.
Change in impulsiveness
Time frame: One week before the start of the intervention, one week after the end of the intervention.
Matching Familiar (MF-20) test from Italian Battery for ADHD (Marzocchi, Re, \& Cornoldi, 2010). In the Matching Familiar Figures (MF) test, participants are shown a figure and are asked to find the matching one among six choices. This task measures the children's impulsiveness. The MF test includes 20 items. Clinicians sum children's score in accuracy and latency time to arrive at one reported value, that is the children's impulsiveness score.
Change in sustained attention capacities
Time frame: One week before the start of the intervention, one week after the end of the intervention.
Bells Test Revised The Bells Test revised (Biancardi \& Stoppa, 1997) is a test for the evaluation of sustained attention in children. The test is an adaptation of Gauthiers's Bell Test used to assess neglect in adults. The Bells Test has been modified in order to make it suitable to research in developmental age. Items are organized in four different pages, which include each 35 bells. Speed and Accuracy in selecting the target stimuli (bells) are assessed. The Speed score refers to the number of bells found by the child in the first 30 seconds of the task, while the Accuracy score refers to the total number of bells found during the whole task (120 seconds).
5 secondary outcomes
Change in children's mindfulness abilities
Time frame: One week before the start of the intervention, one week after the end of the intervention.
Change in parents' mindfulness abilities
Time frame: One week before the start of the intervention, one week after the end of the intervention.
Change in children's anxiety traits
Time frame: One week before the start of the intervention, one week after the end of the intervention.
Change in parenting practices
Time frame: One week before the start of the intervention, one week after the end of the intervention.
Change in parents' stress
Time frame: One week before the start of the intervention, one week after the end of the intervention.
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 11 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Disruptive Behavior Disorder
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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. This study is not recruiting at the moment.
Pietro Muratori principal investigator
IRCCS Stella Maris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based program in people with Disruptive Behavior Disorder and Oppositional Defiant Disorder, run by IRCCS Fondazione Stella Maris at 1 site in Italy.
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 1 inclusion and 3 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 11 Aug 2020. 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 Italy. 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?
Change in behavioral problems at school (time frame: One week before the start of the intervention, one week after the end of the intervention.). The study lists 5 primary outcomes in all. 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 11 Aug 2020.