NCT03905785

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

April 4, 2019

Last Update Submit

April 4, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • General Health Questionnaire

    Changes from baseline to 8 weeks

  • Parenting stress

    Changes from baseline to 8 weeks

  • Self-esteem

    Changes from baseline to 8 weeks

Study Arms (2)

Parenting Intervention Group(Samarthan)

EXPERIMENTAL

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

Wait list Control group

NO INTERVENTION

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.

Interventions

SamarthanBEHAVIORAL

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.

Parenting Intervention Group(Samarthan)

Eligibility Criteria

Age2 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Parents who consented to join the trial
  • Children aged 2-8 years
  • Mean score on the Eyberg Intensity Scale for clinical issues

You may not qualify if:

  • Any comorbid psychiatric condition in parents or children
  • Substance abuse or diagnosed clinical somatic condition influencing ability to consent or follow intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gyansanjeevani

Jaipur, Rajasthan, India

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Sadhana Sharma, MD

    NMP Medical Research Institute, India

    STUDY CHAIR
  • Neha Sharma, PhD

    Warwick Research Services

    STUDY DIRECTOR
  • Nagamani Krishnamurthy, PhD

    Balavikasa Educational Academy, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 5, 2019

Study Start

February 12, 2018

Primary Completion

October 11, 2018

Study Completion

December 12, 2018

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations