Clinical trial NCT06572254: ECD Newborn Parenting Education Program
Official title: Early Childhood Newborn Parenting Education Program at Primary Health Care Facilities of Pakistan: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parenting
Keywords: Early childhood development
Responsive caregiving
Parenting
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Global Affairs Canada
name: Aga Khan Health Services
First posted: 2024-08-27
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: World Health Organization Quality of Life Scale
timeFrame: Baseline - At birth (1st Interaction)
measure: Karitine Parenting Confidence Scale
timeFrame: Through study completion, 6th month
measure: Responsive Interactions Scale
timeFrame: Through study completion, 6th month
measure: Caregiver Reported Early Development Instruments (CREDI)
timeFrame: Through study completion, 6th month
Secondary outcomes:
Other outcomes:
Locations:
city: Kabul
country: Afghanistan
facility: Aga Khan Health Services
state: Greater Kabul
city: Chitral
country: Pakistan
facility: Aga Khan Health Services
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Aga Khan University
name: Sarah Saleem, FCPS
role: STUDY_CHAIR
References: