An interventional study of Mindfulness-based program in Disruptive Behavior Disorder, Oppositional Defiant Disorder and Attention Deficit and Disruptive Behavior Disorders, sponsored by IRCCS Fondazione Stella Maris. Completed at 1 site in Italy. Open to male participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2020-08-11.
Sponsored by IRCCS Fondazione Stella Maris · Not applicable, Interventional, and Treatment
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.
86 studies on the registry are indexed under Oppositional Defiant Disorder; 16 are open to participants now.
This study's enrollment of 50 is below the median of 102 across 76 interventional studies indexed under Oppositional Defiant Disorder.
Browse Oppositional Defiant Disorder studies →IRCCS Fondazione Stella Maris is the lead sponsor of 46 studies on the registry; 27 are open to participants now.
Compared within Oppositional Defiant Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Attention Deficit and Disruptive Behavior Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Exclusion Criteria:
Children and parents receive the program
Behavioral: Mindfulness-based program
Children and parents receive no-interventions.
The program includes 9 mindfulness-based sessions for children and their parents.
Also known as: Fiore dentro
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: One week before the start of the intervention, one week after the end of the intervention.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One week before the start of the intervention, one week after the end of the intervention.
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2018 to primary completion in Jun 2019, 7 months.
Of 35 non-industry interventional studies with no phase under Oppositional Defiant Disorder, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's 7 months is below that.
Counting every sponsor, half of 36 studies reached it within 28 months; a quarter within 19 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Oppositional Defiant Disorder →
IRCCS Fondazione Stella Maris