Effectiveness of Parenting Intervention for Improving Child Mental Health

Effectiveness of Parenting Intervention for Improving Child Mental Health: Randomised Single Blind Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Mental Health Wellness 1; Behavior Problem; Conduct Disorders in Children
• Intervention / Treatment: Behavioral: Samarthan

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Rajasthan
    • Jaipur, Rajasthan, India
      • Gyansanjeevani

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 8 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Parenting Intervention Group(Samarthan); 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.	Behavioral: Samarthan; 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.
NO_INTERVENTION: Wait list Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Problem Behaviour	Child problem behaviour was assessed using Eyberg Child Behavior Inventory which evaluates parental report of behavioral problems	Change from baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Health Questionnaire	Parents general health was assessed using General Health questionnaire	Changes from baseline to 8 weeks
Parenting stress	Parenting Stress Index measured parenting stress	Changes from baseline to 8 weeks
Self-esteem	Self-esteem in parents were measured using Self-esteem score	Changes from baseline to 8 weeks

Collaborators and Investigators

• Sponsor: NMP Medical Research Institute
• Collaborators: Warwick Research Services; Balavikasa Educational Academy, India
• Investigators: Study Chair: Sadhana Sharma, MD, NMP Medical Research Institute, India; Principal Investigator: Nagamani Krishnamurthy, PhD, Balavikasa Educational Academy, India

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 12, 2018
• Primary Completion (ACTUAL): October 11, 2018
• Study Completion (ACTUAL): December 12, 2018

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 4, 2019
• First Posted (ACTUAL): April 5, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 4, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Problem Behavior; Conduct Disorder
• Other Study ID Numbers: NMP/Bala/02189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No