Mindfulness-based Program for Children With Disruptive Behavior Disorder

NCT03698240 | Completed DMC

• 1 other identifier: MIND-DBD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Mindfulness; ADHD; Oppositional Defiant Disorder

Outcome Measures

Primary Outcomes (5)

• 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).

  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.

  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.

  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.

  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).

  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

  One week before the start of the intervention, one week after the end of the intervention.

• Change in parents' mindfulness abilities

  One week before the start of the intervention, one week after the end of the intervention.

• Change in children's anxiety traits

  One week before the start of the intervention, one week after the end of the intervention.

• Change in parenting practices

  One week before the start of the intervention, one week after the end of the intervention.

• Change in parents' stress

  One week before the start of the intervention, one week after the end of the intervention.

Study Arms (2)

Mindfulness-based program

EXPERIMENTAL

Children and parents receive the program

Behavioral: Mindfulness-based program

Waiting-list

NO INTERVENTION

Children and parents receive no-interventions.

Interventions

Mindfulness-based program BEHAVIORAL

The program includes 9 mindfulness-based sessions for children and their parents.

Also known as: Fiore dentro

Mindfulness-based program

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Disruptive Behavior primary diagnosis

You may not qualify if:

• IQ \< 80
• ASD diagnosis
• ongoing other interventions

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• University of Pisa: collaborator

Study Sites (1)

IRCCS Stella Maris

Pisa, 56100, Italy

Location

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders; Oppositional Defiant Disorder; Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Pietro Muratori

  IRCCS Stella Maris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: October 5, 2018
• Study Start: October 4, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2020
• Last Updated: August 11, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)