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Clinical Trials/NCT03698240
NCT03698240
Completed
N/A

Mindfulness-based Program for Children With Disruptive Behavior Disorder

IRCCS Fondazione Stella Maris1 site in 1 country50 target enrollmentOctober 4, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Disruptive Behavior Disorder
Sponsor
IRCCS Fondazione Stella Maris
Enrollment
50
Locations
1
Primary Endpoint
Change in impulsiveness
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 4, 2018
End Date
June 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Disruptive Behavior primary diagnosis

Exclusion Criteria

  • ASD diagnosis
  • ongoing other interventions

Outcomes

Primary Outcomes

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 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 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 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 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).

Secondary Outcomes

  • 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 Sites (1)

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