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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03905785
Other study ID # NMP/Bala/02189
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 12, 2018
Est. completion date December 12, 2018

Study information

Verified date April 2019
Source NMP Medical Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date December 12, 2018
Est. primary completion date October 11, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 8 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
India Gyansanjeevani Jaipur Rajasthan

Sponsors (3)

Lead Sponsor Collaborator
NMP Medical Research Institute Balavikasa Educational Academy, India, Warwick Research Services

Country where clinical trial is conducted

India, 

Outcome

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