ECD Newborn Parenting Education Program

NCT06572254 | Recruiting DMC

• 1 other identifier: 8343
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Parenting

Keywords

Early childhood development; Responsive caregiving; Parenting

Outcome Measures

Primary Outcomes (4)

• World Health Organization Quality of Life Scale

  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

  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

  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)

  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

Study Arms (2)

Self-study Pictorial Module

NO INTERVENTION

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.

Monthly Sessions and Self-study handouts

EXPERIMENTAL

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

Interventions

Early Childhood Development Newborn Parenting Education Program OTHER

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.

Also known as: Early Childhood Development Newborn Responsive Caregiving

Monthly Sessions and Self-study handouts

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Newborn or mother with underlying conditions or morbidities
• Living under 15000 per month

Sponsors & Collaborators

• Aga Khan University: lead
• Global Affairs Canada: collaborator
• Aga Khan Health Services: collaborator

Study Sites (2)

Aga Khan Health Services

Kabul, Greater Kabul, 1001, Afghanistan

COMPLETED

Aga Khan Health Services

Chitral, Khyber Pakhtunkhwa, 17130, Pakistan

RECRUITING

Related Links

• A Packet for Parenting Education on Early Childhood Newborn Responsive Caregiving
• "A Packet for Parenting Education on Early Childhood Newborn Responsive Caregiving

Study Officials

• Sarah Saleem, FCPS

  Aga Khan University

  STUDY CHAIR

Central Study Contacts

Dr. Shelina Bhamani, PhD

CONTACT

03355134134; shelina.bhamani@aku.edu

Sara Sheikh, MScN

CONTACT

03313596023; sara.sheikh@aku.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants in the study will be randomly assigned to either the intervention arm, where they will receive the newborn parenting education program, or the control arm, where they will not receive any intervention. The participants will not be informed of their group allocation to minimize potential bias in their reporting of outcomes. Healthcare providers and researchers involved in the delivery of the intervention and data collection will be aware of the group allocations due to the practical requirements of implementing the education program.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Professor, Lead Early Childhood Development and Program Director Outreach Education, Department of Obstetrics and Gynecology

Model Details: This study uses a parallel interventional design with two arms: an intervention group receiving a newborn parenting education program and a control group receiving no intervention. The primary aim is to compare parental confidence, feeding practices, teaching practices, and experiences between the two groups. Additionally, it assesses pre- and post-training experiences of nurses and healthcare providers and explores the readiness for large-scale implementation of the program in primary healthcare settings

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 27, 2024
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

AF (1); PA (1)