Behavioral Assessment of Children, Early Intervention
Conditions
Keywords
Preterm infant, Parental stress, Early child development, Parenting in the neonatal intensive care
Brief 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. 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.
Interventions
BEHAVIORALComprehensive structured parent intervention
1. 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
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 21 Days
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child developmental outcome | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiological state - Oxygen saturation | 1 year | Physiological parameters including oxygen saturation will be retrieved from the bedside monitors. |
| Neurobehavioral state | 1 year | 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 |
| Parental Knowledge assessment | Before hospital discharge | Parental knowledge assessment test will be administered before and after the education sessions using 10 true/false questions regarding topics addressed in the sessions. |
| Physiological state- Respiratory rate | 1 year | Physiological parameters including respiratory rate will be retrieved from the bedside monitors. |
| Behavioral parenting activities | 1 year | 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. |
| Parents perceptions | 1 year | 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. |
| Parental stress | 1 year | 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. |
Countries
Lebanon
Outcome results
None listed