Comparing the Effectiveness of Group Emotion-Focused and Behavioral Interventions for mothers in Children with Attention Deficit/Hyperactivity Disorder
Comparing the effectiveness of group Emotion-focused and Behavioral interventions for mothers in children with Attention Deficit/Hyperactivity Disorder, before intervention, after intervention and follow up
Comparing the effectiveness of group Emotion-focused and Behavioral interventions for mothers in mothers of children with Attention Deficit/Hyperactivity Disorder, before intervention ,after intervention and follow up
Design
Randomized Clinical Trail with pre-test, post-test and follow-up assessment with intervention and control groups
Settings and conduct
Participants are mothers who have children diagnosed with Attention Deficit/Hyperactivity Disorder
The study is performed in Tehran Psychiatric Institute clinic
Participants/Inclusion and exclusion criteria
Diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) based on Kiddie schedule for Affective Disorder and Schizophrenia-Present and Lifetime Version (K-SADS-PL), Age range for children is between 6 to 10, Minimum education for mothers is diploma, Comorbidity with Autism Spectrum Disorders and Mental Retardation, Non Pharmaco-Therapeutic intervention for mothers or children 6 months before intervention, Starting Pharmacotherapy for mothers or children in accordance with the intervention or during it, Diagnosis of Psychotic Disorders or being in Major Depression / Mania Episodes in mothers
Intervention groups
Emotion-focused intervention group
Behavioral intervention group
Main outcome variables
Attention Deficit/Hyperactivity Disorder symptom severity in children
Externalizing problems in children
Emotion regulation in children
Maternal emotion socialization
Maternal well being
Parenting stress in mothers
Maternal Emotion regulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190915044776N1
Registration date:2020-04-06, 1399/01/18
Registration timing:retrospective
Last update:2020-04-06, 1399/01/18
Update count:0
Registration date
2020-04-06, 1399/01/18
Registrant information
Name
Ghazaleh Zargarinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 0623
Email address
zargarinejad.gh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-29, 1398/08/07
Expected recruitment end date
2019-11-28, 1398/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effectiveness of Group Emotion-Focused and Behavioral Interventions for mothers in Children with Attention Deficit/Hyperactivity Disorder
Public title
Comparing the Effectiveness of Group Emotion-Focused and Behavioral Interventions for mothers in Children with Attention Deficit/Hyperactivity Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) based on Kiddie schedule for Affective Disorder and Schizophrenia- Present and Lifetime Version (K-SADS-PL)
Age range for children is limited to 6 to 10 years
Minimum education for mothers is diploma
Exclusion criteria:
Comorbidity with Bipolar Spectrum Disorders, Autism Spectrum Disorder and Mental Retardation in children
Non-pharmacological interventions for mothers or children 6 months before intervention
starting Pharmacotherapy for mothers or children in accordance with the intervention or during it
Diagnosis of Psychotic Disorders or being in Major Depression / Mania Episodes in mothers
Age
From 6 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The participants are randomly assigned using blocked randomization to three groups (two intervention groups and one control group). Randomization is performed using //www.sealedenvelope.com/. Considering the number of groups (three groups), the block size is 6 and fixed. We have 9 blocks. In each block, two participants are randomly assigned to the first intervention group (Emotion Focused), two participants to the second intervention group (Behavioral) and two participants to control group(waiting list).
Blinding (investigator's opinion)
Single blinded
Blinding description
Statistical Analyst is unaware of the personal codes of the intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
5th floor, Iran University of medical Sciences, Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-10-01, 1398/07/09
Ethics committee reference number
IR.IUMS.REC.1398.701
Health conditions studied
1
Description of health condition studied
Attention Deficit/Hyperactivity Disorder
ICD-10 code
F90
ICD-10 code description
Attention-deficit hyperactivity disorders
Primary outcomes
1
Description
Symptoms of Attention Deficit/Hyperactivity Disorder
Timepoint
Pretest, Post test and 2-month Follow-up
Method of measurement
Swanson, Nolan and Pelham–IV Questionnaire (SNAP-IV)
2
Description
Child's Externalizing Behaviors
Timepoint
Pretest, Post test and 2-month Follow-up
Method of measurement
Eyberg Child Behavior Inventory (ECBI)
3
Description
Child's Emotion Regulation
Timepoint
Pretest, Post test and 2-month Follow-up
Method of measurement
Emotion Regulation Checklist (ERC)
4
Description
Emotion Socialization
Timepoint
Pretest, Post test and 2-month Follow-up
Method of measurement
Coping with Children's Negative Emotions Scale (CCNES)
5
Description
Psychological Symptoms: Anxiety, Depression and Stress
Timepoint
Pretest, Post test and 2-month Follow-up
Method of measurement
Depression Anxiety Stress Scales (DASS-21)
6
Description
Parenting Stress
Timepoint
Pretest, Post test and 2-month Follow-up
Method of measurement
Parenting Stress Index-Short Form (PSI-SF)
7
Description
Mother's Emotion Regulation
Timepoint
Pretest, Post test and 2-month Follow-up
Method of measurement
Difficulties in Emotion Regulation Scale (DERS)
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention Group (Emotion Focused Intervention): In this study, Emotion Focused Intervention is applied using "Emotions Program" which was developed by Shortt and Eddy (2014). The objective of the "Emotions Program" was to teach emotion regulation and emotion coaching parenting skills to mothers. The Emotion Focused Intervention is consisted of 15 2-hr group weekly sessions for mothers. Nine of the sessions focus on strengthening emotion regulation skills and the remaining six sessions target emotion coaching skills. The parent emotion-regulation component was informed by key ideas and strategies from Dialectical Behavior Therapy (DBT) which was developed by Linehan (1993). The content of the sessions is focused on being aware of emotions and thoughts, mindfulness, experiencing emotions without making judgment, calming down strong emotions, healthy coping and responding effectively to life’s events. The emotion coaching component was derived from the Tuning In to Kids (TIK) which was developed by Havighurst & Harley (2007). Emotion coaching reflects a unique parenting behavior and socialization process whereby parents provide guidance to their children in understanding and coping with emotions. Some handouts and practices are presented to mothers each sessions which are related to the session content.
Category
Behavior
2
Description
Second Intervention Group (Behavioral Parenting): Behavioral parenting in this research is implemented using the Level 4 of Positive Parenting Program (Triple P) which was developed by Sanders & his colleagues (2000) for parents of children with more severe behavioral difficulties. This is an 8-session group parenting program (5 sessions for 2 hours and 3 telephone sessions for 15-30 minutes) for each mothers. Behavioral parenting programs, such as Triple P are based on behavioral approach and learning theory. Sessions of Triple P involve monitoring problem child behavior, stimulus control (e.g., identifying antecedents to problem behavior, promoting a more positive environment) , rewards for appropriate behavior, directed discussion , giving clear instructions and behavior-consequences (e.g., time-out, planned ignoring). Some handouts and practices are presented to mothers each sessions which are related to the session content.
Category
Behavior
3
Description
Control Group (Waiting List): Waiting list in this research includes mothers of children diagnosed with Attention deficit hyperactivity disorder which are selected based on inclusion criteria. They do not receive the intervention until the intervention phase of the research is finished. It is explained for mothers on the waiting list that their sessions would begin after five months due to research purpose. The mothers are asked to complete the same questionnaires using the same instruments and concurrent with intervention groups.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Child Psychiatric Clinic of Tehran Psychiatric Institute
Full name of responsible person
Ghazale Zargarinejad
Street address
No 1, mansoori Alley, Niaiesh St, Satarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
ghzargar57@gmail.com
Web page address
http://tip.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Shams Mehrabadi
Street address
No 1, mansoori Alley, Niaiesh St, Satarkhan Ave
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6347 1209
Email
research.tip@iums.ac.ir
Web page address
http://tip.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghazaleh Zargarinejad
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit East 4, No.76, St 22th, Amirabad Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1437644841
Phone
+98 21 8801 0623
Email
Zargarinejad.gh@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghazaleh Zargarinejad
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit East 4, No.76, St 22th, Amirabad Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1437644841
Phone
+98 21 8801 0623
Email
Zargarinejad.gh@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghazaleh Zargarinejad
Position
Ph.D Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit East 4, No.76, St 22th, Amirabad Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1437644841
Phone
+98 21 8801 0623
Email
ghzargar57@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data will be presented in the statistical analysis section in the future articles
When the data will become available and for how long
Nearly six months to one year after the termination of the project
To whom data/document is available
All mental health practitioners who will read the articles
Under which criteria data/document could be used
Researchers who aim to conduct any related studies on the data
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
Sending email and explaining about the research aims