| CTRI Number |
CTRI/2018/09/015822 [Registered on: 25/09/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/09/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Parental lifestyle Guidelines] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of parental education programme on in autism spectrum disorders |
|
Scientific Title of Study
|
Effectiveness of parental education programme on ayurvedic lifestyle in autism spectrum disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRajesh N |
| Designation |
Senior medical officer |
| Affiliation |
Govt.Ayurveda Dispensary |
| Address |
Neelamana
Karuvissery P.O
Kozhikode
Edachery P.O, Kozhikode, Kerala, 673502
Kozhikode
KERALA
673010
India |
| Phone |
9447541819 |
| Fax |
|
| Email |
rajeshnayu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DINESH KS |
| Designation |
Associate professor |
| Affiliation |
V.P.S.V.AYURVEDA COLLEGE |
| Address |
V.P.S.V.AYURVEDA COLLEGE, KOTTAKKAL,
V.P.S.V.AYURVEDA COLLEGE, KOTTAKKAL,
Malappuram
KERALA
676501
India |
| Phone |
09447698085 |
| Fax |
|
| Email |
drayurksd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DINESH KS |
| Designation |
|
| Affiliation |
V.P.S.V.AYURVEDA COLLEGE |
| Address |
ASSOCIATE PROFESSOR AND HEAD, V.P.S.V.AYURVEDA COLLEGE, KOTTAKKAL,
ASSOCIATE PROFESSOR AND HEAD, V.P.S.V.AYURVEDA COLLEGE, KOTTAKKAL,
Malappuram
KERALA
676501
India |
| Phone |
09447698085 |
| Fax |
|
| Email |
drayurksd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam PS Varier Ayurveda College, Kottakkal |
|
|
Primary Sponsor
|
| Name |
VAIDYARATNAM PS VARIER AYURVEDA COLLEGE |
| Address |
EDARIKODE, MALAPPURAM, KERALA |
| Type of Sponsor |
Other [GOVERNEMENT AIDED COLLEGE] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR DINESH KS |
V.P.S.V.AYURVEDA COLLEGE HOSPITAL |
DEPARTMENT OF KAUMARABHRITYA, VAIDYARATNAM PS VARIER AYURVEDA COLLEGE, KOTTAKKAL, MALAPPURAM,KERALA
Malappuram
KERALA |
9447698085
drayurksd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PARENTS OF CHILDREN WITH AUTISM SPECTRUM DISORDERS |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NO COMPARISON DONE |
THIS IS AN OPEN SINGLE ARM STUDY |
| Intervention |
PARENTAL EDUCATION PROGRAM |
The parents were educated using a prepared module onĀyurvedic lifestyle modifications.The training was imparted through a 4-days in-house training programme in two batches. The parents were educated on approach of ASD in Āyurveda, biological rhythm, roles of lifestyle management, diet, natural urges, sleep and Yoga in ASD management and expressed emotions. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1.Parenting figures of children diagnosed with ASD (DSM-5) of age group between 3 – 15 years
2.No discrimination of sex, religion and economic status
3.Participants willing to give written consent |
|
| ExclusionCriteria |
| Details |
1.Parenting figures with major systemic illnesses
2.Parenting figures with major psychiatric disorders / cognitive impairments
3.Parenting figures with lower educational status that may interfere with the proper transaction of the educational module
4.Parenting figures of children with severe global developmental delay with profound cognitive deficits |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.improvement in CARS scale in children
2.An improvement in Indian scale for assessment of autism-
3-A positive deflection in the Family Impact questionare
4.Improvement in quality of life of the selected parents assessed by WHO-QOL-BREF |
ALL OUTCOME WERE STARTED TO GAIN IN THREE MONTHS OF TIME |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PARENTING FIGURES OF AUTISM CHILDREN WILL GET EFFECTIVE LIFESTYLE GUIDELINES TO ACHIEVE A BETTER HEALTH AND BETTER CARS SCALE |
3 YEARS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "88"
Final Enrollment numbers achieved (India)="88" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2017 |
| Date of Study Completion (India) |
06/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="4"
Days="23" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Autism Spectrum Disorders (ASD) is a neuro-developmental disorder, having a previous nomenclature of Pervasive Developmental Disorders in DSM-4.The objectives of the intervention were to reduce the family distress by the application of Āyurvedic principles of lifestyle modifications and dietetics and thereby to improve the functional independence of children. Methods An open clinical trial was conducted in the year 2016-17 at VPSV Ayurveda College among 100 parenting figures of 55 autistic children. The parents were educated using a prepared module onĀyurvedic lifestyle modifications.The training was imparted through a 4-days in-house training programme in two batches. The parents were educated on approach of ASD in Āyurveda, biological rhythm, roles of lifestyle management, diet, natural urges, sleep and Yoga in ASD management and expressed emotions.Participants fulfilling the DSM-5 diagnostic criteriawere enrolled for the study. Assessment Parents were assessed with WHO QOL and Family Impact Questionnaires and children with CARS and ISAA, before and after 8 weeks. Data were analysed using paired t test, chi square test and Pierson’s Rank Correlation Testusing SPSS v16.0. Results Significant changes were noticed in all domains of parental quality of life and in overall autistic features of children (p < 0.001). There is a mild association of parental stress and autistic features of children, which was found not statistically significant. Conclusion The results of this study can be incorporated by Āyurvedic practitioners across the country to manage the quality of life of parents and to improve the autistic features of children. Key Words Autism Spectrum Disorder, parental education, Ayurvedic lifestyle management |