ECD Newborn Parenting Education Program

NCT ID: NCT06572254

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2025-03-31

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.

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.

Conditions

Parenting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Early Childhood Development Newborn Parenting Education Program

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Early Childhood Development Newborn Responsive Caregiving

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Global Affairs Canada

OTHER

Sponsor Role: collaborator

Aga Khan Health Services

OTHER

Sponsor Role: collaborator

Aga Khan University

OTHER

Sponsor Role: lead

Responsible Party

Shelina Bhamani

Asst Professor, Lead Early Childhood Development and Program Director Outreach Education, Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sarah Saleem, FCPS

Role: STUDY_CHAIR

Aga Khan University

Locations

Aga Khan Health Services

Kabul, Greater Kabul, Afghanistan

Site Status: COMPLETED

Aga Khan Health Services

Chitral, Khyber Pakhtunkhwa, Pakistan

Site Status: RECRUITING

Countries

Afghanistan; Pakistan

Central Contacts

Dr. Shelina Bhamani, PhD

Role: CONTACT

shelina.bhamani@aku.edu

03355134134 ext. 02134864645

Sara Sheikh, MScN

Role: CONTACT

sara.sheikh@aku.edu

03313596023

Facility Contacts

Aisha Mab

Role: primary

aisha.maab@akhsp.org

3406253939

Sanober Nadeem

Role: backup

sanober.nadeem@akhsp.org

03013301554

Related Links

https://www.aku.edu/mcpk/obs-gyn/Documents/ECD-English.pdf

A Packet for Parenting Education on Early Childhood Newborn Responsive Caregiving

https://www.aku.edu/mcpk/obs-gyn/Documents/ECD-Urdu.pdf

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

Other Identifiers

8343

Identifier Type: -

Identifier Source: org_study_id