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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
NMP Medical Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Behavior Problem

Eligibility Criteria

2 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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

First Posted
April 4, 2019
Last Updated
April 4, 2019
Sponsor
NMP Medical Research Institute
Collaborators
Warwick Research Services, Balavikasa Educational Academy, India
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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

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Effectiveness of Parenting Intervention for Improving Child Mental Health

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