An interventional study of Early Childhood Development Newborn Parenting Education Program in Parenting, sponsored by Aga Khan University. Recruiting at 2 sites in 2 countries. Open to female participants. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Aga Khan University · Not applicable, Interventional, and Other
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.
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.
Aga Khan University is the lead sponsor of 294 studies on the registry; 43 are open to participants now.
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Exclusion Criteria:
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.
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.
Also known as: Early Childhood Development Newborn Responsive Caregiving
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".
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: Through study completion, 6th month
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Plan to share: No — Investigators may not share the individual participant data but investigators plan to publish papers with partners from both countries and share the final results
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