| CTRI Number |
CTRI/2020/08/027451 [Registered on: 28/08/2020] Trial Registered Prospectively |
| Last Modified On: |
16/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Well-being intervention for Indian adolescents in psychiatric setting |
|
Scientific Title of Study
|
Well-being intervention for adolescents in out patient psychiatric setting: A preliminary evaluation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ahil |
| Designation |
Ph D scholar |
| Affiliation |
NIMHANS |
| Address |
Ahil N, MVGovindaswamy block, 3 rd floor, Department of clinical psychology,
NIMHANS
Ahil N, MVGovindaswamy block, 3 rd floor, Department of clinical psychology,
NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
09489137278 |
| Fax |
|
| Email |
ahilnallathambi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uma Hirisave |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Dr Uma Hirisave,
Professor,
departmetn of clinical psychology, M V Govindaswamy block, 3rd floor, NIMHANS
NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
9900143301 |
| Fax |
|
| Email |
drumahirisave@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ahil |
| Designation |
PhD scholar |
| Affiliation |
Student |
| Address |
MVGovindaswamy block,
3rd floor
department of clinical psychology, NIMHANS
NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
09489137278 |
| Fax |
|
| Email |
ahilnallathambi@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health And Neuro Sciences (NIMHANS), Bangalore |
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
NIMHANS, Bangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR UMA HIRISAVE |
NIMHANS Bangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| N Ahil |
NIMHANS |
Department of Clinical Psychologyy
Bangalore
KARNATAKA |
09489137278
ahilnallathambi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F90-F98||Behavioral and emotional disorders with onset usually occurring in childhood and adolescence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Well-being intervention |
Well-being intervention refers to the Well-being therapy (WBT) for children and adolescents with emotional and behavioral disturbances by Albieri et al (2009) based on Ryff’s psychological well-being model with the aim of improving the emotional and psychological well-being of adolescents. The plan of this study is to conduct 6-8 individual sessions of well-being intervention, based on the above model. This will be an adjunct to routine clinical care in the follow-up. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Adolescents, aged 12-17 years consulting CAP OPD, NIMHANS for follow up
2. Hyperkinetic disorders (F90), Conduct disorders (F91), Mixed disorders of conduct and emotions (F92), Emotional disorders with onset specific to childhood (F93), Disorders of social functioning with onset specific to childhood and adolescence (F94), Tic disorders (F95), Other behavioral and emotional disorders with onset usually occurring in childhood and adolescence (F96), unspecified mental disorder (F99), Mental disorders, not otherwise specified (F99)
3. Mania without psychotic symptoms (F30.1), bipolar affective disorder- current episode hypomania (F31.0), current episode mania without psychotic symptoms (F31.1), current episode mild or moderate depression (F31.3), current episode severe depression without psychotic symptoms (F31.4), current episode mixed (F31.6), mild depressive episode (F32.0), moderate depressive episode (F32.1), severe depressive episode without psychotic symptoms (F32.1), recurrent depressive disorder – mild (F33.0), moderate (F33.1), severe without psychotic symptoms (F33.2), cyclothymia (F34.0), Dysthymia (F34.1)
4. Neurotic, stress-related and somatoform disorders (F40-F48), Behavioral syndromes associated with physiological disturbance and physical factors (F50-F59)
5. CGI score of 4 or less than 4 in severity domain
6. CGAS score of 50 to 90
7. Participants who can converse and write in English/Tamil (Language restriction of researcher)
8. Accompanied by parent/s
|
|
| ExclusionCriteria |
| Details |
Clinical evidence of
1. Mental retardation (F70-F79)
2. Specific developmental disorders of speech and language (F80), Specific developmental disorders of motor function (F82), Mixed specific developmental disorders (F83), Pervasive developmental disorders (F84), Other disorders of psychological development (F88) and Unspecified disorder of psychological development (F89)
3. Schizophrenia (F20)
4. Mania with psychotic symptoms (F30.2), Bipolar affective disorder, current episode mania with psychotic symptoms (F31.2), Bipolar affective disorder, current episode severe depression with psychotic symptoms (F31.5), Severe depression with psychotic symptoms (F32.3), recurrent depressive disorder, current episode severe with psychotic symptoms (F33.3)
5. Organic mental disorders (F00-F09)
Adolescents with diagnosis of Substance Use Disorder who consumed alcohol/ any substances in last 3 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Score on Sterling Children’s Well-Being Scale
score on subjective Happiness Scale
score on Self-esteem scale
score on Functional status questionnaire |
pre assessment
post assessment
follow up after one month
follow up after three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
score on my experience scale
outcomes on changes in daily routine
outcomes on feedback of the intervention |
pre assessment
post assessment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/11/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study aims at examining the
effect of the Well-Being intervention for adolescents attending follow up
services in Child and adolescent out-patient psychiatric setting. The primary
objectives are to examine the effect of well-being intervention on emotional
well-being of adolescents, on psychological well-being of adolescents and on
adolescent’s functioning and to examine the feasibility of the well-being
intervention. The study design to achieve the aim is open label trial- single
group pre, post, follow-up design. Well-being intervention refers to the Well-being therapy (WBT) for
children and adolescents with emotional and behavioural disturbance by Albieri
et al (2009) based on Ryff’s psychological well-being model with the aim of
improving the emotional and psychological well-being of adolescents. The plan
of this study is to conduct 8 individual sessions of well-being intervention,
based on the above model (online/ in person). This will be an adjunct to routine clinical care in
the follow-up. Adolescents scoring CGI score of 4 or less
than 4 in severity domain, CGAS score of 50-90 and who can converse and write
in English/Tamil (Language restriction of researcher) will be included in the
study. Clinical evidence of Mental retardation (F70-F79), Specific
developmental disorders of speech and language (F80), Specific developmental
disorders of motor function (F82), Mixed specific developmental disorders (F83,
Pervasive developmental disorders (F84), Other disorders of psychological
development (F88) and Unspecified disorder of psychological development (F89),
Adolescents who consumed alcohol/ any substances in last 3 months, disorders
with psychotic symptoms/ neurological disorders will be excluded from the
study. Repeated Measures ANOVA/ Friedman test
would be used to compare the means between follow up, post and pre intervention
based on the normality of the difference and homogeneity of variance between
the groups to check for the effect of intervention.
|