NCT03472222

Brief Summary

Substance abuse remain critical problems in both developed and developing countries. Under privileged communities where health and economic system is weakest, use of drugs and illicit substances starts during adolescence and young adulthood. This not just affect physical development, mental health and social integration, but also family formation and stability, deviant behaviour, sexual behaviour and involvement, educational pursuits, livelihood pursuits. Therefore, emphasises the need for preventive education at this impressionable age.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2018

Completed
Last Updated

May 24, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

February 24, 2018

Last Update Submit

May 22, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percent days abstinent of tobacco, alcohol and drugs

    Daily Dairy was given to assess days abstinent of tobacco, alcohol and drugs

    change from baseline to 12-weeks

Secondary Outcomes (1)

  • Well being

    change from baseline to 12-weeks

Other Outcomes (1)

  • Craving

    change from baseline to 12-weeks

Study Arms (1)

Arsha Vidya Program

EXPERIMENTAL

Arsha Vidya outreach community program was conducted with children. An unique well-planned teaching program developed to educate Indian cultural values \& heritage to young children and adults with yoga, chants, religious and spiritual practices through stories, group activities and plays.

Behavioral: Arsha Vidya program

Interventions

Integrated intervention program includes counselling and supportive care with the support of Arsha Vidya program

Arsha Vidya Program

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parental consent to participate

You may not qualify if:

  • Family not involved in de-addiction program
  • Planning to move the area
  • Mental incapacity to consent or participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMP Medical Reserach Institute

Ahmedabad, Gujarat, India

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Buddhatmananda Saraswati

    Arsha Vidya Study Centre, India

    STUDY CHAIR
  • Rajubhai P Odedra

    NMP Medical Research Institute

    PRINCIPAL INVESTIGATOR
  • Divya Gaur

    United Research International

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Quasi experimental design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2018

First Posted

March 21, 2018

Study Start

February 21, 2018

Primary Completion

August 30, 2018

Study Completion

September 6, 2018

Last Updated

May 24, 2019

Record last verified: 2019-01

Locations