Clinical trial NCT03698240: Mindfulness-based Program for Children With Disruptive Behavior Disorder
Official title: Mindfulness-based Program for Children With Disruptive Behavior Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disruptive Behavior Disorder
Oppositional Defiant Disorder
Attention Deficit and Disruptive Behavior Disorders
Keywords: Mindfulness
ADHD
Oppositional Defiant Disorder
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
Collaborators: name: University of Pisa
First posted: 2018-10-05
Enrollment: 50
Sex: MALE
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Disruptive Behavior primary diagnosis

Exclusion Criteria:

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

Primary outcomes:
measure: Change in behavioral problems at school
timeFrame: One week before the start of the intervention, one week after the end of the intervention.
measure: Change in Aggressive behaviors
timeFrame: One week before the start of the intervention, one week after the end of the intervention.
measure: Change in Behavioral problems at home
timeFrame: One week before the start of the intervention, one week after the end of the intervention.
measure: Change in impulsiveness
timeFrame: One week before the start of the intervention, one week after the end of the intervention.
measure: Change in sustained attention capacities
timeFrame: One week before the start of the intervention, one week after the end of the intervention.
Secondary outcomes:
measure: Change in children's mindfulness abilities
timeFrame: One week before the start of the intervention, one week after the end of the intervention.
measure: Change in parents' mindfulness abilities
timeFrame: One week before the start of the intervention, one week after the end of the intervention.
measure: Change in children's anxiety traits
timeFrame: One week before the start of the intervention, one week after the end of the intervention.
measure: Change in parenting practices
timeFrame: One week before the start of the intervention, one week after the end of the intervention.
measure: Change in parents' stress
timeFrame: One week before the start of the intervention, one week after the end of the intervention.
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: IRCCS Stella Maris
Study officials:
affiliation: IRCCS Stella Maris
name: Pietro Muratori
role: PRINCIPAL_INVESTIGATOR
References: