Protocol summary

Summary
(1) Objective: This study aims to determine the effectiveness of mindful parenting training on parental parenting stress, clinical symptoms and self efficacy in children with attention deficit hyperactivity disorder. (2) Design: This study is a randomized clinical trial with two groups (experimental and control) in three phases (per-test, post-test and follow up). (3) Setting and conduct: Sixty children with ADHD diagnosis and their mothers who are eligible for inclusion and exclusion are selected. They will assign in two groups randomly (mindful parenting and control). Participants of both group receive pharmacotherapy (risperidone or Ritalin). participants of both group fill out Swanson, Nolan and Pelham parenting rating scale (SNAP-IV); children self-efficacy questionnaire (SEQ-C); parenting stress index- short form (PSI-SF36) as per-test, post-test and two month after intervention as follow- up. The intervention will be done for mothers that have children with ADHA in 8 sessions. The data will be analyzed by spss-21, using the multivariate analysis of covariance (MANCOVA). (4) Inclusion: Children are having with attention deficit hyperactivity disorder (ADHD) according to a psychiatrist; age 7-12 years; receiving regular pharmacotherapy by risperidone or Ritalin; their mothers are having minimum education level of diploma. Exclusion criteria: Mother or child having intellectual disability, psychosis or major mood disorder; receiving pharmacotherapy unregularly. (5) Interventions: The intervention consist of 8 sessions (each session last 90 minutes) of mindful parenting training based on Kabat-Zinn protocol in experimental group. The control group doesn’t receive any psychotherapy. (6) Main outcome measures: Main outcome measures variables are clinical symptoms and self-efficacy in children and parenting stress in their mothers.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016021026505N1
Registration date: 2016-02-22, 1394/12/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-02-22, 1394/12/03
Registrant information
Name
Mahdieh Behbahani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 659 1568
Email address
behbahani-ma@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of mindful parenting training on parental parenting stress, clinical symptoms and self-efficacy in children with attention deficit hyperactivity disorder
Public title
Effect of mindful parenting training on parental parenting stress, clinical symptoms and self-efficacy in children with attention deficit hyperactivity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Participant including major eligibility inclusion criteria are patients with the diagnosis of attention deficit hyperactivity disorder by a psychiatrist; child aged 7-12 years; children receive pharmacotherapy by Risperidone or Ritalin; their parent have minimum education level of diploma; having willingness to participate in the research. Exclusion criteria: Parent or child with diagnosis of intellectual disability by a psychiatrist; child have bipolar concurrent disorder; psychiatrist change dosage of drug child.
Age
From 7 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences and Health Services
Street address
Kashan University of Medical Sciences and Health Services, 5th Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Approval date
2016-01-21, 1394/11/01
Ethics committee reference number
IR.KAUMS.REC.1394.143

Health conditions studied

1

Description of health condition studied
Attention deficit hyperactivity disorder
ICD-10 code
F90.0
ICD-10 code description
Disturbance of activity and attention

Primary outcomes

1

Description
Parental parenting stress
Timepoint
Before intervention, after intervention, two month after intervention
Method of measurement
Parenting stress index- short form (PSI-SF36)

Secondary outcomes

1

Description
Clinical symptoms
Timepoint
Before intervention, after intervention, two month after intervention
Method of measurement
Swanson, Nolan and Pelham parenting rating scale (SNAP-IV) (diagnosis and classification of attention deficit hyperactivity disorder)

2

Description
Self-efficacy for children
Timepoint
Before intervention, after intervention, two month after intervention
Method of measurement
Children self-efficacy questionnaire (SEQ-C)

Intervention groups

1

Description
The intervention consist of 8 sessions (each session last 90 minutes) of mindful parenting training based on Kabat-Zinn protocol in experimental group.
Category
Behavior

2

Description
Pharmacotherapy by Risperidone or Ritalin in control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kargaer-Nejad psychiatric center
Full name of responsible person
Dr Fatemeh Assariyan
Street address
Kashan University of Medical Sciences and Health Services, 5th qotbe Ravandi Blvd, Kashan
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Full name of responsible person
Dr Qolam ali Hamidi
Street address
Kashan University of Medical Sciences and Health Services, 5th Qotbe Ravandi Blvd, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Mahdieh Behbahani
Position
M.Sc Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Kashan University of Medical Sciences and Health Services, 5th Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 2999
Fax
Email
behbahani-ma@kaums.ac.ir, psy.m.behbahani@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Mahdieh Behbahani
Position
M.Sc Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Kashan University of Medical Sciences and Health Services, 5th Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
behbahani-ma@kaums.ac.ir, psy.m.behbahani@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Mahdieh Behbahani
Position
M.Sc Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Kashan University of Medical Sciences and Health Services, 5th Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 2999
Fax
Email
behbahani- ma @kaums.ac.ir, Psy.m.behbahani@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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