| 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
|
|
|
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 |
|
|
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. |