A Clinical trial for evaluation of the efficacy of parenting skills group training to the mothers of children with Attention Deficit Hyperactivity Disorder (ADHD) on the quality of life of the children
This study will be designed, as a clinical trial with pre- and post- tests, aiming to evaluate the impact of the parenting skills group training to the mothers of children with Attention Deficit Hyperactivity Disorder (ADHD) on the quality of life of the children. The study population will include 60 cases of the children with Attention Deficit Hyperactivity Disorder (ADHD) 8 to 12 years referring to the psychiatric center of Guil of Rasht. After attendance at the psychiatric center of Guil of Rasht, the patients are selected by a psychiatrist based on a clinical interview according to diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5). The mothers of patients with Attention Deficit Hyperactivity Disorder meet the inclusion and exclusion criteria; will be entered in the study after obtaining informed consent. Using convenient sampling, the samples will be divided randomly into two groups of the intervention and the control. The training process will be continued for eight sessions of 90 minutes and using Positive Parenting Program (Triple P), by a child and adolescent psychiatrist in the psychiatric clinic of Guil of Rasht. The efficacy of the training will be evaluated last session and then three months after based on the scores obtained from the Pediatric Quality of Life Questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701297237N2
Registration date:2017-04-14, 1396/01/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-14, 1396/01/25
Registrant information
Name
Maryam Kousha
Name of organization / entity
Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 1163
Email address
m-kousha@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical trial for evaluation of the efficacy of parenting skills group training to the mothers of children with Attention Deficit Hyperactivity Disorder (ADHD) on the quality of life of the children
Public title
A Clinical trial for evaluation of the efficacy of parenting skills group training to the mothers of children with Attention Deficit Hyperactivity Disorder (ADHD) on the quality of life of the children
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Children 8 to 12 years with a diagnosis of Attention Deficit Disorder / Hyperactivity Disorder and Oppositional Defiant Disorder (ODD),children who receive medical treatment and will response with optimal dosage , mother cooperation with the researcher and her regular attendance training sessions, minimum qualification of the mother is third grade of middle school, lack of acute and severe psychiatric illness in the mother, at the same time there are no psychiatric disorders in children with attention deficit disorder / hyperactivity disorder other than ODD, lack of diseases such as epilepsy, mental retardation and Pervasive Developmental Disorders in the child; Exclusion criteria: The reluctance of the mother to continue for cooperation in research
Age
From 8 years old to 12 years old
Gender
Both
Phase
3
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
The random numbers table will be used for random selection
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti Blvd,Opposite to the Sepah bank, Above Iran Radiator Representation. Building Of Assistance Research and Technology, Rasht, Iran
Before the start of the first session, at the end of the eighth session and three months after the end of the eighth session
Method of measurement
Pediatric Quality of Life Inventory PedsQl Parent-Proxy Report (ages 8-12)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: For 30 others, mothers of the control group, will be conducted only conventional therapy and routine monthly visits for their sick children
Category
Treatment - Other
2
Description
Intervention group: will be trained about parenting skills during 8 sessions of 90 minutes. The training sessions will be held on a weekly basis and based on common educational content, using Positive Parenting Program (Triple P), by a child and adolescent psychiatrist in the psychiatric clinic of Guil of Rasht.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Psychiatric Clinic Gil, Rasht
Full name of responsible person
Dr Maryam Kousha
Street address
Poursina Avenue, Children's Psychiatric Clinic Gil , Rasht