Effectiveness of group mindfulness based stress reduction on parents of children with Attention Deficit Hyperactivity Disorder on mental health, quality of life and child behavioral problems, a randomized controlled clinical trial
Objectives:. The purpose of the present study is to evaluate the effectiveness of group mindfulness based stress reduction on parents of children with Attention Deficit Hyperactivity Disorder on mental health, quality of life and child behavioral problems. Design: The present study is a randomized clinical trial with control group, a cross sectional study. Setting and conduct: 64 parents of children with ADHD age between 8-16 were selected from the ones who referred to Shiraz University of Medical Sciences polyclinic and divided into experimental and control groups, randomly. Participants including major eligibility criteria: At least primary education (6th class) ; Co-therapy sessions; Agreement to participate in research; The diagnosis of Attention Deficit Hyperactivity Disorder in their children should be confirmed by a psychiatrist in at least the past 3 years and who are unwilling to participate in therapy sessions and whom with other psychiatric or medical problems or chronic diseases in themselves or their children should be excluded from this study. Intervention: All participants completed GHQ-28, SF-36 and SDQ parent form, three times as, pre-test, post-test and follow-up. Experimental group participate in eight, 45 min sections of group therapy base on Mindfulness Based Stress Reduction therapy (MBCT) .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112231021N1
Registration date:2017-03-13, 1395/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-13, 1395/12/23
Registrant information
Name
Samaneh Muosavinasab
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3627 1531
Email address
s_mousavinasab@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of group mindfulness based stress reduction on parents of children with Attention Deficit Hyperactivity Disorder on mental health, quality of life and child behavioral problems, a randomized controlled clinical trial
Public title
Effectiveness of stress reduction on parents of children with Attention Deficit Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1.At least primary education (6th class) ; 2.Co-therapy sessions; 3.Agreement to participate in research; 4.The diagnosis of Attention Deficit Hyperactivity Disorder should be confirmed by a psychiatrist in at least the past 3 years
Exclusion criteria: 1.Unwillingness to participate in therapy sessions; 2.Other psychiatric or medical problems or chronic diseases in children or their parents
Age
From 8 years old to 16 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Siences
Street address
Ethic Comittee, 7th floor, Medical School, Zand St.
City
Shiraz
Postal code
7134814336
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SUMS.MED.REC.1394.76
Health conditions studied
1
Description of health condition studied
ADHD
ICD-10 code
F90.0
ICD-10 code description
Attention deficit:disorder with hyperactivity
Primary outcomes
1
Description
Mental health of mothers of children with ADHD
Timepoint
Before intervention- immediately after intervention- 3 months after intervention
Method of measurement
GHQ-28 inventory
2
Description
Quality of life of mothers of children with ADHD
Timepoint
Before intervention- immediately after intervention- 3 months after intervention
Method of measurement
SF-36 inventory
3
Description
Behavioral problems in child with ADHD
Timepoint
Before intervention- immediately after intervention- 3 months after intervention
Method of measurement
SDQ inventory, parent form
Secondary outcomes
1
Description
level of stress
Timepoint
In sessions
Method of measurement
Observation and self report
Intervention groups
1
Description
The experimental group will participate in therapy sessions. (8 sessions, once a week, for 45 minutes) and in these groups using mindfulness stress reduction techniques are taught