Behavioral Assessment of ChildrenPREPARENCT04783220
PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (PREPARE Trial)
A study testing Comprehensive structured parent intervention in people with Behavioral Assessment of Children and Early Intervention, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Preterm infants are at high risk of developmental delay or disabilities and they do benefit from early intervention programs. Many programs aiming at improving preterm infants' developmental outcome have been proposed with mixed results. Read more about this study
- Who is it for?
- Ages 1 day to 21 daysHealthy volunteers can take part
- Conditions the study is for
- Behavioral Assessment of Children, Early Intervention
- What is being tested?
- Comprehensive structured parent intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Nov 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 1 day to 21 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Couplets of parents and their preterm infants admitted to the NICU, who are <35 weeks gestation at birth and who are deemed medically stable by their treating neonatologist.
Who cannot join
- Infants with significant neurologic disorder precluding meaningful interaction with the parents as determined by the neurologist
- Infants with major congenital anomalies precluding meaningful interaction with the parents as determined by the neurologist
- Infants with systemic medical and/ or surgical conditions precluding interaction with the parents, other than preterm-related intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL).
- Parental refusal to participate
- Absence of clearance from the neonatologist
- Infants planned to be transferred to another facility for their NICU care.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive PaREnting ProgrAm to Enhance PREterm Infants' Health and Development: A Randomized Controlled Trial (PREPARE Trial)
Preterm infants are at high risk of developmental delay or disabilities and they do benefit from early intervention programs. Many programs aiming at improving preterm infants' developmental outcome have been proposed with mixed results. In low to middle-income countries, clinically relevant and effective low cost interventions empowering parents have yet to be established.
Read the detailed description
Education and intervention programs targeting parents of premature infants are lacking in low to middle income countries (LMIC) and in Arabic countries in particular. The main concept of this proposal is to develop a program in Arabic for parents of premature infants with the aim to increase their knowledge about short and long term problems of prematurity, increase their involvement in the care during their stay in the neonatal intensive care unit (NICU) and promote responsive and sensitive parenting in the NICU and after discharge. This is to empower parents and have them become active contributors to enhancing their infant's development through play activities and tracking of developmental milestones.
- Being tested
- Comprehensive structured parent intervention
- Keywords
- Preterm infant, Parental stress, Early child development, Parenting in the neonatal intensive care
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive structured parent interventionBehavioural
- Educational sessions and coaching on infants' behavior cues
- Skills on motor stimulation
- Written instructions for play and stimulation activities at discharge
- Multidisciplinary follow-up
- Developmental tracking and advice via a mobile app
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The parents of babies in this group will receive an educational and intervention program Receives: Behavioral: Comprehensive structured parent intervention |
| Control | No intervention | The parents of babies in this group will receive the standard parent education and follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child developmental outcome
The developmental outcome of preterm children will be assessed using the Ages and Stages Questionnaire at 9 months of corrected age.
The ASQ-3 covers 5 area of child development : Gross Motor, Fine Motor, Problem Solving, Personal-Social, Communication.
Scores for each area should range between minimum 0 and maximum 60. Higher scores indicate that the child is developing properly.
Measured: 9 months
Secondary outcomes (7)
Physiological state- Respiratory rate
Physiological parameters including respiratory rate will be retrieved from the bedside monitors.
Measured: 1 year
Physiological state - Oxygen saturation
Physiological parameters including oxygen saturation will be retrieved from the bedside monitors.
Measured: 1 year
Neurobehavioral state
Behavioral state will be assessed by a cerified trained developmental specialist using a 7-point score that include: (i) Quiet/deep sleep, (ii) Active sleep, (iii) Awake State, (iv) drowsy, (v) quiet alert, (vi) active alert, (vii) crying
Measured: 1 year
Parental Knowledge assessment
Parental knowledge assessment test will be administered before and after the education sessions using 10 true/false questions regarding topics addressed in the sessions.
Measured: Before hospital discharge
Parental stress
The Arabic parenting stress index short form questionnaire will be used. The PSI-SF is a self-administered questionnaire and consists of 36 items divided into three subscales of 12 items each: parental distress, parent-child dysfunctional interaction and difficult child.
For each subscales scores ranges should be between 12 and 60. For the total stress score , the minimum score is 36 and the maximum is 180. Higher scores mean more depressive symptoms.
Measured: 1 year
Behavioral parenting activities
A questionnaire derived from the UNICEF MICS 6 questionnaire will be used. MICS or "MULTIPLE INDICATOR CLUSTER SURVEY" is a tool used to assess the activities of parents with their infants.
Measured: 1 year
Parents perceptions
The Perceived Maternal Parenting Self-Efficacy questionnaire is a standardized valid and reliable instrument to assess parent's perceptions of their ability to care for their infants.
PMP-SE is composed of 20 items divided into four subscales: care taking procedures, evoking behaviours, reading behaviours or signalling, and situational beliefs.
Those items are formulated as statements using a five-point Likert scale. Scoring ranges from 20 to 80 where a higher score indicates a higher self-efficacy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Nov 2021
- Primary completion14 Oct 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral Assessment of ChildrenStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lama Charafeddine, MD, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783220
- Sponsor's protocol ID
- SBS-2020-0365
- Acronym
- PREPARE
- Status last verified
- Feb 2025
- First submitted
- 15 Jan 2021
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive PaREnting ProgrAm to Enhance PREterm Infants' Health and Development: A Randomized Controlled Trial (PREPARE Trial)
- ClinicalTrials.gov ID
- NCT04783220
- Acronym / sponsor ID
- PREPARE / SBS-2020-0365
- Keywords
- Preterm infant, Parental stress, Early child development, Parenting in the neonatal intensive care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 14 Oct 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 5 Mar 2021 (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.
Preterm infants are at high risk of developmental delay or disabilities and they do benefit from early intervention programs. Many programs aiming at improving preterm infants' developmental outcome have been proposed with mixed results. In low to middle-income countries, clinically relevant and effective low cost interventions empowering parents have yet to be established.
Detailed description
Education and intervention programs targeting parents of premature infants are lacking in low to middle income countries (LMIC) and in Arabic countries in particular. The main concept of this proposal is to develop a program in Arabic for parents of premature infants with the aim to increase their knowledge about short and long term problems of prematurity, increase their involvement in the care during their stay in the neonatal intensive care unit (NICU) and promote responsive and sensitive parenting in the NICU and after discharge. This is to empower parents and have them become active contributors to enhancing their infant's development through play activities and tracking of developmental milestones.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Comprehensive structured parent interventionThe parents of babies in this group will receive an educational and intervention program |
| Control | No intervention | –The parents of babies in this group will receive the standard parent education and follow-up. |
Who may qualify
- Ages
- 1 day to 21 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Couplets of parents and their preterm infants admitted to the NICU, who are <35 weeks gestation at birth and who are deemed medically stable by their treating neonatologist.
Key exclusion criteria (6 listed)
- Infants with significant neurologic disorder precluding meaningful interaction with the parents as determined by the neurologist
- Infants with major congenital anomalies precluding meaningful interaction with the parents as determined by the neurologist
- Infants with systemic medical and/ or surgical conditions precluding interaction with the parents, other than preterm-related intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL).
- Parental refusal to participate
- Absence of clearance from the neonatologist
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 |
|---|---|---|
| Comprehensive structured parent intervention1. Educational sessions and coaching on infants' behavior cues 2. Skills on motor stimulation 3. Written instructions for play and stimulation activities at discharge 4. Multidisciplinary follow-up 5. Developmental tracking and advice via a mobile app | Behavioural | Intervention |
Primary outcome
Child developmental outcome
Time frame: 9 months
The developmental outcome of preterm children will be assessed using the Ages and Stages Questionnaire at 9 months of corrected age. The ASQ-3 covers 5 area of child development : Gross Motor, Fine Motor, Problem Solving, Personal-Social, Communication. Scores for each area should range between minimum 0 and maximum 60. Higher scores indicate that the child is developing properly.
7 secondary outcomes
Physiological state- Respiratory rate
Time frame: 1 year
Physiological state - Oxygen saturation
Time frame: 1 year
Neurobehavioral state
Time frame: 1 year
Parental Knowledge assessment
Time frame: Before hospital discharge
Parental stress
Time frame: 1 year
Behavioral parenting activities
Time frame: 1 year
Parents perceptions
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- MICS6 TOOLSLink provided by the sponsor.
- Agency for Healthcare Reserach and Quality (2018). NICU-2-HOME: Using Health IT to Support Parents of NICU Graduates Transitioning to Home (Illinois) \| AHRQ National Resource Center; Health Information Technology: Best Practices Transforming Quality, SLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Lama Charafeddine, MD principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive structured parent intervention in people with Behavioral Assessment of Children and Early Intervention, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child developmental outcome (time frame: 9 months). 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 4 Apr 2025.