Effectiveness of Parenting Intervention for Improving Child Mental Health
Primary Purpose
Behavior Problem, Conduct Disorders in Children, Mental Health Wellness 1
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Samarthan
Sponsored by
About this trial
This is an interventional supportive care trial for Behavior Problem
Eligibility Criteria
Inclusion Criteria:
- Parents who consented to join the trial
- Children aged 2-8 years
- Mean score on the Eyberg Intensity Scale for clinical issues
Exclusion Criteria:
- Any comorbid psychiatric condition in parents or children
- Substance abuse or diagnosed clinical somatic condition influencing ability to consent or follow intervention
Sites / Locations
- Gyansanjeevani
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Parenting Intervention Group(Samarthan)
Wait list Control group
Arm Description
Parenting intervention was designed as group program, training parents in cognitive-behavioural techniques for managing child's difficult behaviour and issues. Program was focused on parent-child problem solving method and positive interaction.
wait list control group was given no intervention for the trial period. They were offered sam intervention after the intervention was completed in experimental group.
Outcomes
Primary Outcome Measures
Child Problem Behaviour
Child problem behaviour was assessed using Eyberg Child Behavior Inventory which evaluates parental report of behavioral problems
Secondary Outcome Measures
General Health Questionnaire
Parents general health was assessed using General Health questionnaire
Parenting stress
Parenting Stress Index measured parenting stress
Self-esteem
Self-esteem in parents were measured using Self-esteem score
Full Information
NCT ID
NCT03905785
First Posted
April 4, 2019
Last Updated
April 4, 2019
Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services, Balavikasa Educational Academy, India
1. Study Identification
Unique Protocol Identification Number
NCT03905785
Brief Title
Effectiveness of Parenting Intervention for Improving Child Mental Health
Official Title
Effectiveness of Parenting Intervention for Improving Child Mental Health: Randomised Single Blind Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 12, 2018 (Actual)
Primary Completion Date
October 11, 2018 (Actual)
Study Completion Date
December 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services, Balavikasa Educational Academy, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In this study, effectiveness of a group parenting intervention was assessed in a community setting, for its impact on child behaviour problems and parental mental health.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Behavior Problem, Conduct Disorders in Children, Mental Health Wellness 1
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Parenting Intervention Group(Samarthan)
Arm Type
Experimental
Arm Description
Parenting intervention was designed as group program, training parents in cognitive-behavioural techniques for managing child's difficult behaviour and issues. Program was focused on parent-child problem solving method and positive interaction.
Arm Title
Wait list Control group
Arm Type
No Intervention
Arm Description
wait list control group was given no intervention for the trial period. They were offered sam intervention after the intervention was completed in experimental group.
Intervention Type
Behavioral
Intervention Name(s)
Samarthan
Intervention Description
Samarthan intervention was designed as group program, training parents in cognitive-behavioural techniques for managing child's difficult behaviour and issues. Program was focused on parent-child problem solving method and positive interaction.
Primary Outcome Measure Information:
Title
Child Problem Behaviour
Description
Child problem behaviour was assessed using Eyberg Child Behavior Inventory which evaluates parental report of behavioral problems
Time Frame
Change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
General Health Questionnaire
Description
Parents general health was assessed using General Health questionnaire
Time Frame
Changes from baseline to 8 weeks
Title
Parenting stress
Description
Parenting Stress Index measured parenting stress
Time Frame
Changes from baseline to 8 weeks
Title
Self-esteem
Description
Self-esteem in parents were measured using Self-esteem score
Time Frame
Changes from baseline to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Parents who consented to join the trial
Children aged 2-8 years
Mean score on the Eyberg Intensity Scale for clinical issues
Exclusion Criteria:
Any comorbid psychiatric condition in parents or children
Substance abuse or diagnosed clinical somatic condition influencing ability to consent or follow intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sadhana Sharma, MD
Organizational Affiliation
NMP Medical Research Institute, India
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Neha Sharma, PhD
Organizational Affiliation
Warwick Research Services
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nagamani Krishnamurthy, PhD
Organizational Affiliation
Balavikasa Educational Academy, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gyansanjeevani
City
Jaipur
State/Province
Rajasthan
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effectiveness of Parenting Intervention for Improving Child Mental Health
We'll reach out to this number within 24 hrs