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Mindfulness-based Program for Children With Disruptive Behavior Disorder

Primary Purpose

Disruptive Behavior Disorder, Oppositional Defiant Disorder, Attention Deficit and Disruptive Behavior Disorders

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Mindfulness-based program
Sponsored by
IRCCS Fondazione Stella Maris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disruptive Behavior Disorder focused on measuring Mindfulness, ADHD, Oppositional Defiant Disorder

Eligibility Criteria

8 Years - 12 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Disruptive Behavior primary diagnosis

Exclusion Criteria:

  • IQ < 80
  • ASD diagnosis
  • ongoing other interventions

Sites / Locations

  • IRCCS Stella Maris

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness-based program

Waiting-list

Arm Description

Children and parents receive the program

Children and parents receive no-interventions.

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
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).

Secondary Outcome Measures

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).
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.
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.
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.
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.

Full Information

First Posted
June 20, 2018
Last Updated
August 9, 2020
Sponsor
IRCCS Fondazione Stella Maris
Collaborators
University of Pisa
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1. Study Identification

Unique Protocol Identification Number
NCT03698240
Brief Title
Mindfulness-based Program for Children With Disruptive Behavior Disorder
Official Title
Mindfulness-based Program for Children With Disruptive Behavior Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Fondazione Stella Maris
Collaborators
University of Pisa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disruptive Behavior Disorder, Oppositional Defiant Disorder, Attention Deficit and Disruptive Behavior Disorders
Keywords
Mindfulness, ADHD, Oppositional Defiant Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-based program
Arm Type
Experimental
Arm Description
Children and parents receive the program
Arm Title
Waiting-list
Arm Type
No Intervention
Arm Description
Children and parents receive no-interventions.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based program
Other Intervention Name(s)
Fiore dentro
Intervention Description
The program includes 9 mindfulness-based sessions for children and their parents.
Primary Outcome Measure Information:
Title
Change in behavioral problems at school
Description
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.
Title
Change in Aggressive behaviors
Description
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.
Title
Change in Behavioral problems at home
Description
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.
Title
Change in impulsiveness
Description
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.
Title
Change in sustained attention capacities
Description
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.
Secondary Outcome Measure Information:
Title
Change in children's mindfulness abilities
Description
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.
Title
Change in parents' mindfulness abilities
Description
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.
Title
Change in children's anxiety traits
Description
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.
Title
Change in parenting practices
Description
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.
Title
Change in parents' stress
Description
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Disruptive Behavior primary diagnosis Exclusion Criteria: IQ < 80 ASD diagnosis ongoing other interventions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pietro Muratori
Organizational Affiliation
IRCCS Stella Maris
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Stella Maris
City
Pisa
ZIP/Postal Code
56100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Mindfulness-based Program for Children With Disruptive Behavior Disorder

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