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CTRI Number  CTRI/2024/07/070102 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 23/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Exploring how college youth manage emotions through peer support. 
Scientific Title of Study   Interpersonal Affect Regulation and its Correlates in the Context of Peer Relationships among College Youth.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Alma Reeba Joseph 
Designation  PhD Scholar 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Clinical Psychology M V Govindswamy Building, 3rd Floor Hosur Road Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  9496437630  
Fax    
Email  almareebaj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Seema Mehrotra 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Clinical Psychology M V Govindswamy Building, 3rd Floor Hosur Road. Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  08026995192  
Fax    
Email  drmehrotra_seema@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Seema Mehrotra 
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Clinical Psychology M V Govindswamy Building, 3rd Floor Hosur Road. Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  08026995192  
Fax    
Email  drmehrotra_seema@yahoo.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neuro Sciences, Hosur Road, Bangalore, 560029 
 
Primary Sponsor  
Name  Alma Reeba Joseph 
Address  Department of Clinical Psychology NIMHANS, Hosur Road, Bangalore, 560029 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
National Institute of Mental Health and Neuro Sciences   Hosur Road, Bangalore 560029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Seema Mehrotra  National Institute of Mental Health and Neurosciences  Department of Clinical Psychology M V Govindswamy Building, 3rd Floor Hosur Road, Bangalore
Bangalore
KARNATAKA 
9448503853

drmehrotra_seema@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not Applicable 
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Youth between 18-25 years of age.
2. Youth able to speak and read in English.
3. All genders
4. College students 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Secondary Outcome  
Outcome  TimePoints 
Not Applicable  Not Applicable 
 
Target Sample Size   Total Sample Size="700"
Sample Size from India="700" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This study aims to explore Interpersonal Affect Regulation (IAR) among college youth, engagement in IAR, perceived barriers and facilitators within peer relationships. It investigates the nature of IAR and its relationship with emotion regulation difficulties. It also examines the role of various factors, such as gender, distress disclosure, perceived social support, and the strength of peer ties, as predictors of IAR. In addition, the study seeks to determine how IAR predicts psychological distress and emotional well-being and aims to identify distinct profiles related to IAR and emotion regulation difficulties. By employing exploratory sequential mixed method design, this study is conducted in 3 phases. To explore youth perspectives on peer support for distress, perceived barriers and facilitators, and engagement in Interpersonal Affect Regulation (IAR) within peer relationships, two focused group discussions will be conducted with 8-12 participants each in their college campuses. Participants will be recruited from one government and one private university, using convenience sampling. Efforts will be made to include younger and older participants of all genders from diverse disciplines. To understand the correlates of IAR, a survey will be conducted recruiting 700 college students from various private and government colleges ensuring representation from all genders and disciplines through purposive sampling. The survey will be conducted offline in their college campuses in a group administration format after obtaining written informed consent participants.  A subsample of 20 youth from the survey participants will be selected for one-one-one interviews to explore interpersonal affect regulation experiences and processes within peer relationships. A pilot study will be conducted before the main study to refine survey tools, to estimate time take for interview and survey, familiarise with the data collection process and to ensure reliability and validity of the tools. The tools used for the study include basic data sheet, Received Assistance in Regulating Emotions Questionnaire (Urano et al., 2022), Interpersonal Emotion-Regulation Questionnaire (Hofmann et al., 2016), Interpersonal Emotion Management Scale (Little et al., 2011), Difficulties in Emotional Regulation Scale- Short Form (Kaufman et al., 2016), Multidimensional Scale of Perceived Social Support (Zimet et al. 1988), Strength of ties with peers’ network (Morris, 2023), Distress Disclosure Index (Kahn et al., 2001),  Kessler Psychological Distress Scale (Kessler et al., 2002), and Positive and Negative Affect Schedule ((Rao & Mehrotra, 2006). Data analysis will employ descriptive statistics, including mean, standard deviation, frequencies, and percentages, to summarize quantitative data. Correlation analysis (Pearson or Spearman) will examine relationships between emotion regulation difficulties (DERS) and interpersonal affect regulation (IAR). Differences between subgroups will be tested using independent sample t-tests or Mann-Whitney U tests. Structural equation modelling will explore direct and indirect variable relationships, while multiple linear regression will identify predictors of IAR and its impact on distress and well-being. Latent class modelling will identify subgroups based on IAR and emotion regulation difficulties, and multinomial logistic regression will analyse the influence of gender, social support, peer ties, and distress disclosure on affect regulation profiles. Qualitative data from Event Reconstruction Method (ERM) and focus group discussions (FGDs) will be analysed using content analysis.

 

 

 
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