ParentingNCT06572254
ECD Newborn Parenting Education Program
A study testing Early Childhood Development Newborn Parenting Education Program in people with Parenting, run by Aga Khan University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Parenting
- What is being tested?
- Early Childhood Development Newborn Parenting Education Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Normal delivery
- No underlying morbidities of the newborn
- Are not living in ultra-poverty less than 15000/- total household income.
Who cannot join
- Newborn or mother with underlying conditions or morbidities
- Living under 15000 per month
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Afghanistan1 site
- Completed
Aga Khan Health Services
Kabul, Greater Kabul, 1001
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan Health Services
Chitral, Khyber Pakhtunkhwa, 17130
Aisha Mab, 3406253939, aisha.maab@akhsp.org
Sanober Nadeem, 03013301554, sanober.nadeem@akhsp.org
About this study
Official title: 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.
Read the 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
- Being tested
- Early Childhood Development Newborn Parenting Education Program
- Keywords
- Early childhood development, Responsive caregiving, Parenting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Childhood Development Newborn Parenting Education ProgramOther
Also called Early Childhood Development Newborn Responsive Caregiving
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Early Childhood Development Newborn Parenting Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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.
Measured: 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".
Measured: Through study completion, 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Global Affairs Canada, Aga Khan Health Services
- Responsible party
- Principal investigator, Shelina Bhamani, Aga Khan University
- Investigators
- Sarah Saleem, FCPS, Study chair, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572254
- Sponsor's protocol ID
- 8343
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Childhood Newborn Parenting Education Program at Primary Health Care Facilities of Pakistan: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06572254
- Acronym / sponsor ID
- 8343
- Conditions
- Parenting
- Keywords
- Early childhood development, Responsive caregiving, Parenting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Global Affairs Canada, Aga Khan Health Services
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Early Childhood Development Newborn Parenting Education ProgramThe 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Normal delivery
- No underlying morbidities of the newborn
- Are not living in ultra-poverty less than 15000/- total household income.
Key exclusion criteria (2 listed)
- Newborn or mother with underlying conditions or morbidities
- Living under 15000 per month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Childhood Development Newborn Parenting Education ProgramAlso: Early Childhood Development Newborn Responsive CaregivingInvestigators 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 | Monthly Sessions and Self-study handouts |
Primary outcome
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".
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.
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.
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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- A Packet for Parenting Education on Early Childhood Newborn Responsive CaregivingLink provided by the sponsor.
- "A Packet for Parenting Education on Early Childhood Newborn Responsive CaregivingLink provided by the sponsor.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Saleem, FCPS study chair
Aga Khan University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Childhood Development Newborn Parenting Education Program in people with Parenting, run by Aga Khan University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Afghanistan, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Shelina Bhamani, PhD (03355134134 ext. 02134864645, shelina.bhamani@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Quality of Life Scale (time frame: Baseline - At birth (1st Interaction)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.