ECD Newborn Parenting Education Program

August 26, 2024 updated by: Shelina Bhamani, Aga Khan University

Early Childhood Newborn Parenting Education Program at Primary Health Care Facilities of Pakistan: A Feasibility Study

Early childhood development: specifically the first 1000 days of life are of crucial importance. It sets the trajectory for the future and transgenerational health. Life of a neonate is influenced by several factors of which responsive caregiving is one of the most imperative facets. In the earliest days of life, the role of responsive caregiving is vital for the child's growing brain. Interactions between the primary caregiver and the neonate in early infancy period foster social and cognitive growth, build trust, provide sense of security, and helps build brain of the young child. In resource constraints areas, particularly in primary health care settings, there is a lack of initiatives to support responsive caregiving. The investigators intend to do an implementation adaptation and assessment of impact and efficacy of early childhood newborn parenting education program at primary health care facilities of Pakistan and Afghanistan. Investigators already have a structured program at our tertiary health care setting, with this project, investigators now intend to adapt it to primary care settings of Aga Khan Health Services Pakistan and Afghanistan a) explore the impact of newborn parenting education program on parental outcomes b) conduct training for health care providers and asses their pre-post knowledge and skills and c) explore systems readiness to scale up this program at national level. The expected outcome of this research is to build a proof of concept of this intervention in primary healthcare settings and disseminate its findings for a national level scale up and to advocate the importance of it to the government sector, civil society organization and funding agencies.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The first 1000 days of life are critical to the growth and early brain development. Responsive caregiving lays the foundation of early childhood development and future acquisition of skills. Nurturing care provided by primary caregivers can activate different brain systems, allowing children to feel safe, form connections, and foster emotional and cognitive growth. A child's ability to adapt to adversity and stress in the future relies on a strong foundation of care provided in early childhood. The investigators also commit to be part of this movement and want to help realize the right of every child to survive and thrive, to build a more sustainable future for all. investigators are working on providing optimal care and wellbeing opportunities to the young children and this continuous and involved parenting support needs to start before birth and continue until the age of eight. The investigators will broadly take implementation research approach using different strategies for different aims. Hence for this research, investigators want to implement and adapt this same model in primary care settings of remote Pakistan and Afghanistan. The investigators have chosen Aga Khan Health Services Pakistan (AKHSP) and Aga Khan Health Services, Afghanistan (AKHSA), Foundation for Health and Empowerment (F4HE) field sites. The current research is also proposed in the same geographies that are part of F4HE, although F4HE has very strong implementation the research part is missing, so this research will fill the research gap and build knowledge on early childhood responsive caregiving in primary health care settings. AKHS has its primary care setup all over Pakistan and Afghanistan and the following BHCs will be chosen to implement this research and make the intervention sustainable.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Afghanistan
    • Greater Kabul
      • Kabul, Greater Kabul, Afghanistan, 1001
        • Completed
        • Aga Khan Health Services
  • Pakistan
    • Khyber Pakhtunkhwa
      • Chitral, Khyber Pakhtunkhwa, Pakistan, 17130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Normal delivery
  2. No underlying morbidities of the newborn
  3. Are not living in ultra-poverty less than 15000/- total household income.

Exclusion Criteria:

  1. Newborn or mother with underlying conditions or morbidities
  2. Living under 15000 per month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Self-study Pictorial Module
The control group will only be provided with a self-study pictorial module, and they will be tracked and requested to visit the center at the 6 months (child age) post-delivery. At 6 months, their data on responsive interactions, parenting confidence, and patient experience will be collected.
Experimental: Monthly Sessions and Self-study handouts
The intervention will undergo a 6-month intervention consisting of 1 session at birth with a self-study manual, and 5 monthly sessions (once a month till the infant turns 6 months). At 6 months, they will also be assessed on the measures mentioned above.
Other: Early Childhood Development Newborn Parenting Education Program
Investigators will be adapting the model used here at the tertiary care of newborn parenting which investogators have developed based on the nurturing care framework and keys to the caregiving framework. Both models have shown reliable evidence of their effectiveness.
Other Names:
  • Early Childhood Development Newborn Responsive Caregiving

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
World Health Organization Quality of Life Scale
Time Frame: Baseline - At birth (1st Interaction)
scale assesses an individual's perceived quality of life, including their physical health, psychological state, social relationships, and environmental factors. It evaluates how an individual's health status affects their overall well-being, happiness, and life satisfaction. The minimum value in the scale which is "1" indicates "very poor" while the maximum value which is "5" indicates "very good".
Baseline - At birth (1st Interaction)
Karitine Parenting Confidence Scale
Time Frame: Through study completion, 6th month
it consists of 15 items and is used by professionals. The items help explore caregivers' confidence in caring for their infants. It is a self-reported questionnaire and minimal clinical instructions are required to fill it. There are 4 Likert scale options out of which the minimum "0" indicates "No, hardly ever" while maximum is "3" which indicates "Yes, most of the time ". Parents scoring 39 or below indicate of experiencing low confidence while parents scoring 40 and above indicate high levels of confidence.
Through study completion, 6th month
Responsive Interactions Scale
Time Frame: Through study completion, 6th month
it consists of 15 items and is used by professionals. The items help explore caregivers' confidence in caring for their infants. It is a self-reported questionnaire and minimal clinical instructions are required to fill it. There are 4 Likert scale options out of which the minimum "0" indicates "No, hardly ever" while maximum is "3" which indicates "Yes, most of the time ". Parents scoring 39 or below indicate of experiencing low confidence while parents scoring 40 and above indicate high levels of confidence.
Through study completion, 6th month
Caregiver Reported Early Development Instruments (CREDI)
Time Frame: Through study completion, 6th month
The 20-item questionnaire is a brief version of the full Caregiver Reported Early Development Instruments, capturing essential developmental domains: cognitive, language, motor, and socio-emotional development. The minimum score is "0" while the maximum score is "20".
Through study completion, 6th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aga Khan University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aga Khan Health Services
Global Affairs Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Sarah Saleem, FCPS, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 8343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Investigators may not share the individual participant data but investigators plan to publish papers with partners from both countries and share the final results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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