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IRCT20190915044776N1 IRCT 2020-04-06 Iran University of Medical Sciences 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 2019-10-29 anticipated 54 Complete https://irct.ir/trial/42199 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 description: Statistical Analyst is unaware of the personal codes of the intervention and control groups. N/A Attention Deficit/Hyperactivity Disorder. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Yes - There is a plan to make this available What will be shared: Data will be presented in the statistical analysis section in the future articles When: Nearly six months to one year after the termination of the project To whom: All mental health practitioners who will read the articles Conditions: Researchers who aim to conduct any related studies on the data Where to obtain: Corresponding author How to obtain: Sending email and explaining about the research aims Comments:
public Ghazaleh Zargarinejad
Unit East 4, No.76, St 22th, Amirabad Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1437644841 +98 21 8801 0623 Zargarinejad.gh@iums.ac.ir Iran University of Medical Sciences scientific Ghazaleh Zargarinejad
Unit East 4, No.76, St 22th, Amirabad Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1437644841 +98 21 8801 0623 Zargarinejad.gh@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 6 years 10 years Both 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 F90 Attention-deficit hyperactivity disorders Behavior Behavior N/A 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. 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. 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. 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). Child's Externalizing Behaviors. Timepoint: Pretest, Post test and 2-month Follow-up. Method of measurement: Eyberg Child Behavior Inventory (ECBI). Child's Emotion Regulation. Timepoint: Pretest, Post test and 2-month Follow-up. Method of measurement: Emotion Regulation Checklist (ERC). Emotion Socialization. Timepoint: Pretest, Post test and 2-month Follow-up. Method of measurement: Coping with Children's Negative Emotions Scale (CCNES). Psychological Symptoms: Anxiety, Depression and Stress. Timepoint: Pretest, Post test and 2-month Follow-up. Method of measurement: Depression Anxiety Stress Scales (DASS-21). Parenting Stress. Timepoint: Pretest, Post test and 2-month Follow-up. Method of measurement: Parenting Stress Index-Short Form (PSI-SF). Mother's Emotion Regulation. Timepoint: Pretest, Post test and 2-month Follow-up. Method of measurement: Difficulties in Emotion Regulation Scale (DERS). Iran University of Medical Sciences Approved 2019-10-01 Ethics committee of Iran University of Medical Sciences 5th floor, Iran University of medical Sciences, Hemmat Highway, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)