Behavior ProblemNCT03905785
Effectiveness of Parenting Intervention for Improving Child Mental Health
A study testing Samarthan in people with Behavior Problem and Conduct Disorders in Children, run by NMP Medical Research Institute at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior Problem, Conduct Disorders in Children, Mental Health Wellness 1
- What is being tested?
- Samarthan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteIndia
- Study dates
- 12 Feb 2018to 12 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents who consented to join the trial
- Children aged 2-8 years
- Mean score on the Eyberg Intensity Scale for clinical issues
Who cannot join
- Any comorbid psychiatric condition in parents or children
- Substance abuse or diagnosed clinical somatic condition influencing ability to consent or follow intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Samarthan
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SamarthanBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Problem Behaviour
Child problem behaviour was assessed using Eyberg Child Behavior Inventory which evaluates parental report of behavioral problems
Measured: Change from baseline to 8 weeks
Secondary outcomes (3)
General Health Questionnaire
Parents general health was assessed using General Health questionnaire
Measured: Changes from baseline to 8 weeks
Parenting stress
Parenting Stress Index measured parenting stress
Measured: Changes from baseline to 8 weeks
Self-esteem
Self-esteem in parents were measured using Self-esteem score
Measured: Changes from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start12 Feb 2018
- Primary completion11 Oct 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior ProblemStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- NMP Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Warwick Research Services, Balavikasa Educational Academy, India
- Responsible party
- Sponsor
- Investigators
- Sadhana Sharma, MD, Study chair, NMP Medical Research Institute, IndiaNeha Sharma, PhD, Study director, Warwick Research ServicesNagamani Krishnamurthy, PhD, Principal investigator, Balavikasa Educational Academy, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905785
- Sponsor's protocol ID
- NMP/Bala/02189
- Status last verified
- Apr 2019
- First submitted
- 4 Apr 2019
- Last updated
- 5 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Parenting Intervention for Improving Child Mental Health: Randomised Single Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03905785
- Acronym / sponsor ID
- NMP/Bala/02189
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- NMP Medical Research InstituteUniversity, hospital or other
- Collaborators
- Warwick Research Services, Balavikasa Educational Academy, India
- Study start
- 12 Feb 2018 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenting Intervention Group(Samarthan) | Experimental | Behavioral: SamarthanParenting 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 | 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. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Parents who consented to join the trial
- Children aged 2-8 years
- Mean score on the Eyberg Intensity Scale for clinical issues
Key exclusion criteria (2 listed)
- Any comorbid psychiatric condition in parents or children
- Substance abuse or diagnosed clinical somatic condition influencing ability to consent or follow intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SamarthanSamarthan 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. | Behavioural | Parenting Intervention Group(Samarthan) |
Primary outcome
Child Problem Behaviour
Time frame: Change from baseline to 8 weeks
Child problem behaviour was assessed using Eyberg Child Behavior Inventory which evaluates parental report of behavioral problems
3 secondary outcomes
General Health Questionnaire
Time frame: Changes from baseline to 8 weeks
Parenting stress
Time frame: Changes from baseline to 8 weeks
Self-esteem
Time frame: Changes from baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadhana Sharma, MD study chair
NMP Medical Research Institute, India
Neha Sharma, PhD study director
Warwick Research Services
Nagamani Krishnamurthy, PhD principal investigator
Balavikasa Educational Academy, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Samarthan in people with Behavior Problem and Conduct Disorders in Children, run by NMP Medical Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Problem Behaviour (time frame: Change from baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.