Neurobehavioral Outcomes of Children with Antenatal Exposure to Antiseizure Medications.

OBJECTIVES: To evaluate the effect of antiepileptic medications prescribed to mothers during pregnancy on the development and behavior of children. METHODS: From the Kerala Registry of Epilepsy and Pregnancy, 98 children between the ages of 1½ to 2½ y were consecutively chosen. Children of mothers who did not have epilepsy during pregnancy and not exposed to antiseizure medications (ASMs) antenatally were selected as comparator group. Developmental assessment of the children was performed using Developmental Assessment Scale for Indian Infants (DASII) and Receptive-Expressive Emergent Language Scale (REELS). Behavior outcomes were assessed using Child Behavior Checklist. RESULTS: A significant delay in expressive language skills was seen in children exposed to antiseizure medication with an odds ratio of 2.539 (95% CI 1.10, 5.85, P = 0.026). A delay in expressive language skills was seen in polytherapy with clobazam (odds ratio 6.83; 95% CI 2.17, 21.56, P < 0.001). Also, delay was seen in receptive language skills in the same polytherapy group (odds ratio of 7.333; 95% CI 2.16, 24.92, P < 0.001). There were no statistically significant differences between study and comparative groups in motor and mental quotient domains and behavioral outcomes. CONCLUSIONS: The finding of speech delay in children exposed to ASMs is significant since individuals with a history of childhood speech or language disorders may experience long-term difficulties in mental health, social well-being, and academic outcomes.

Development and Validation of a Tool for Assessing Pre-Writing Skills of 2-5 y old Children.

OBJECTIVES: To develop a tool to assess pre-writing skills of 2-5 y old children in India. METHODS: The tool development process followed the recommendations by Fitzpatrick et al. and the Consensus based Standards for the selection of health Measurement Instruments (COSMIN), and included 4 phases. In Phase I, an initial 35-item draft tool was developed by an expert panel for the tool-development. In Phase II, the 35-item draft tool was prevalidated through peer and expert reviews, pilot-study to assess the tool-comprehensibility, and assessment of test-retest and inter-rater reliability. In Phase III, the 35-item draft tool was administered on the 575 typically developing children aged 2-5 y, recruited from rural, urban, slum, and coastal areas through stratified random sampling. In Phase IV, the normative age-range for development of each item was generated by calculating the age-percentiles (10th, 25th, 50th, 75th, 90th). Factor analysis and item reduction was done for items in 2-3, 3-4, and 4-5 y age-groups. The final tool was converted to graphic format with 10th-90th age-percentile bars. RESULTS: The final tool had 26 items with a three-factor structure. Cronbach's alpha was within acceptable limits for all three age-groups (0.723, 0.778, and 0.823 in 2-3 y, 3-4 y, and 4-5 y respectively). Kappa coefficients of the items ranged from 0.6-1 in interrater reliability and 0.64-1 test-retest reliability analysis reflecting substantial agreement between ratings. CONCLUSIONS: A 26-item screening tool "Prewriting skills Assessment Tool" (PAT) to assess writing readiness of 2-5 y old children was developed. Tool reliability and construct validity have been established.

Prevalence of Specific Learning Disorders (SLD) Among Children in India: A Systematic Review and Meta-Analysis.

Background: Specific learning disorders (SLD) comprise varied conditions with ongoing problems in one of the three areas of educational skills-reading, writing, and arithmetic-which are essential for the learning process. There is a dearth of systematic reviews focused exclusively on the prevalence of SLD in India. Hence, this study was done to estimate the prevalence of SLD in Indian children. Methods: A systematic search of electronic databases of MEDLINE, Embase, PsycINFO, and CINAHL was conducted. Two authors independently assessed the eligibility of the full-text articles. The third author reassessed all selected studies. A standardized data extraction form was developed and piloted. The pooled prevalence of SLDs was estimated from the reported prevalence of eligible studies, using the random-effects model. Results: Six studies of the systematic review included the diagnostic screening of 8133 children. The random-effects meta-analysis showed that the overall pooled prevalence of SLD in India was 8% (95% CI = 4-11). The tools used to diagnose SLD in the studies were the National Institute of Mental Health and Neurosciences (NIMHANS)-SLD index and the Grade Level Assessment Device (GLAD). Conclusions: Nearly 8% of children up to 19 years have SLD. There are only a few high-quality, methodologically sound, population-based epidemiological studies on this topic. There is a pressing need to have large population-based surveys in India, using appropriate screening and diagnostic tools. Constructing standardized assessment tools, keeping in view the diversity of Indian culture, is also necessary.

CDC Kerala--The Untold Story.

This article is our life time experience in conceptualizing and systematically developing Child Development Centre (CDC) Kerala in the last 25 years, from a research project to a national training centre in child and adolescent development and premarital counseling. CDC Kerala's major contribution was in creating a 'conceptual framework' of a valid link between childhood disability, low birth weight, adolescent girls' nutrition and fetal onset adult lifestyle diseases. It all started with a randomized controlled trial (RCT) proving beyond doubt that early stimulation is effective in improving the neurodevelopmental status of high risk babies at one and two years and the same cohort was followed-up in detail at 5, 13, 16, 19 and 24 completed years. The process of establishing CDC Kerala is being presented under (i) clinical child development, (ii) adolescent care counseling, (iii) young adults and premarital counseling and (iv) institution building.

CDC Kerala 10: Diagnostic accuracy of the severity scores for childhood autism rating scale in India.

OBJECTIVE: To document the diagnostic accuracy of the Childhood Autism Scale (CARS) thresholds to identify mild, moderate and severe autism in India. METHODS: The CARS scores of 623 children, with and without autism were compared against the Diagnostic and Statistical Manual for Mental Disorders 4th edition (DSM-IV-TR) for ASD diagnosis and clinical consensus between two developmental paediatricians as the reference standard for autism severity using the Receiver operating characteristics (ROC) curve analyses and contingency tables. RESULTS: The CARS total score for mild, moderate and severe autism ranged from 30.5 to 35, 35.5-40 and ≥40.5 respectively in this study. The overall diagnostic accuracy of CARS total score in the mild range was moderate [AUC = 0.68 (95%CI = 0.62-0.88), z = 1.34; P = 0.18], moderate range was high [AUC = 0.90 (95%CI = 0.77-0.97), z = 8.62; P = 0.0001] and severe range was also high [AUC = 0.85 (95%CI = 0.77-0.90), z = 7.09; P = 0.0001]. CONCLUSIONS: There are validated severity scores for Childhood Autism Rating Scale for clinical and research use in India.

CDC Kerala 2: Developmental intervention package for babies <1,800 g--outcome at 6 mo using DASII.

OBJECTIVES: To describe the experience of using developmental intervention package among low birth weight babies less than 1,800 g and developmental outcome at the end of 6 mo monthly intervention. METHODS: Babies below 1,800 g, discharged from neonatal intensive care unit (NICU) of Sree Avittom Thirunal (SAT) hospital, over the last 3 y, were followed at Child Development Centre (CDC) Kerala and offered monthly evaluation by different tools and developmental intervention using a package by trained developmental therapists and mothers were encouraged to continue the same at home. At the end of 6 mo the developmental outcome was assessed using Developmental Assessment Scale for Indian Infants (DASII). RESULTS: Out of a total of 821 babies enrolled for early stimulation program, 740 babies successfully completed 6 mo follow up and stimulation program. Comparing the outcome at 4 and 6 mo, both grading for head holding and gross motor part of DDST showed a statistically significant reduction in abnormal findings. At 6 mo assessment on DASII, motor DQ abnormalities were a high 80% for 600-900 g, as against 17.1% abnormalities for 1,500-1,800 g birth weight group. CONCLUSIONS: The results of this intensive early stimulation program for babies below 1,800 g have shown the importance of monthly early intervention using a mother oriented systematic developmental stimulation package.

CDC Kerala 15: Developmental Evaluation Clinic (2-10 y)--developmental diagnosis and use of home intervention package.

OBJECTIVE: To describe the last 5 years' experience of Child Development Centre (CDC), Kerala Developmental Evaluation Clinic II for children between 2 and 10 y, referred for suspicion of developmental lag in the preschool years and scholastic difficulty in the primary classes with specific focus on developmental profile and the experience of the home based intervention package taught to the mothers. METHODS: A team of evaluators including developmental therapist, preschool teacher with special training in clinical child development, speech therapist, special educator, clinical psychologist and developmental pediatrician assessed all the children referred to CDC Kerala. Denver Developmental Screening Test (DDST-II), Vineland Social Maturity Scale (VSMS) and Intelligent Quotient (IQ) tests were administered to all children below 6 y and those above 6 with apparent developmental delay. RESULTS: Speech/delay (35.9%), behavior problem (15.4%), global delay/ intellectual disability (15.4%), learning problem (10.9%), pervasive developmental disorders (7.7%), seizure disorder (1.7%), hearing impairment (0.7%), and visual impairment (0.7%) were the clinical diagnosis by a developmental pediatrician. Each child with developmental problem was offered a home based intervention package consisting of developmental therapy and special education items, appropriate to the clinical diagnosis of the individual child and the same was taught to the mother. CONCLUSIONS: The experience of conducting the developmental evaluation clinic for children between 2 and 10 y has shown that a team consisting of developmental therapist, speech therapist, preschool teacher, special educator, clinical child psychologist and developmental pediatrician, using appropriate test results of the child could make a clinical diagnosis good enough for providing early intervention therapy using a home based intervention package.

CDC Kerala 7: Effect of early language intervention among children 0-3 y with speech and language delay.

OBJECTIVE: To assess the effect of systematic clinic and home based early language intervention program in children reporting to the early language intervention clinic with full partnership of specially trained developmental therapist and the parents. METHODS: All babies between 0 and 3 y referred to Child Development Centre (CDC) Kerala for suspected speech/language delay were assessed and those without hearing impairment were screened first using Language Evaluation Scale Trivandrum (LEST) and assessed in detail using Receptive Expressive Emergent Language Scale (REELS). Those having language delay are enrolled into the early language intervention program for a period of 6 mo, 1 h at the CDC clinic once every month followed by home stimulation for rest of the month by the mother trained at CDC. RESULTS: Out of the total 455 children between 0 and 3 y, who successfully completed 6 mo intervention, the mean pre and post intervention language quotient (LQ) were 60.79 and 70.62 respectively and the observed 9.83 increase was statistically significant. The developmental diagnosis included developmental delay (62.4%), global developmental delay (18.5%), Trisomy and other chromosomal abnormalities (10.5%), microcephaly and other brain problems (9.9%), misarticulation (8.4%), autistic features (5.3%) and cleft palate and lip (3.3%) in the descending order. CONCLUSIONS: In the present study among 455 children between 0 and 3 y without hearing impairment, who successfully completed 6 mo early language intervention, the mean pre and post intervention LQ were 60.79 and 70.62 respectively and the observed 9.83 increase was statistically significant.

CDC Kerala 1: Organization of clinical child development services (1987-2013).

OBJECTIVE: The main objective of establishing the Child Development Centre (CDC), Kerala for piloting comprehensive child adolescent development program in India, has been to understand the conceptualization, design and scaling up of a pro-active positive child development initiative, easily replicable all over India. METHODS: The process of establishing the Child Development Centre (CDC) Kerala for research, clinical services, training and community extension services over the last 25 y, has been as follows; Step 1: Conceptualization--The life cycle approach to child development; Step 2: Research basis--CDC model early stimulation is effective; Step 3: Development and validation of seven simple developmental screening tools; Step 4: CDC Diagnostic services--Ultrasonology and genetic, and metabolic laboratory; Step 5: Developing seven intervention packages; Step 6: Training--Post graduate diploma in clinical child development; Step 7: CDC Clinic Services--seven major ones; Step 8: CDC Community Services--Child development referral units; Step 9: Community service delivery models--Childhood disability and for adolescent care counselling projects; Step 10: National capacity building--Four child development related courses. RESULTS: CDC Kerala follow-up and clinic services are offered till 18 y of age and premarital counselling till 24 y of age as shown in "CDC Kerala Clinic Services Flow Chart" and 74,291 children have availed CDC clinic services in the last 10 y. CONCLUSIONS: CDC Kerala is the first model for comprehensive child adolescent development services using a lifecycle approach in the Government sector and hence declared as the collaborative centre for Rashtriya Bal Swasthya Karyakram (RBSK), in Kerala.

CDC Kerala 4: TDSC items based developmental therapy package among low birth weight babies--outcome at 18 months using DASII.

OBJECTIVE: To assess the effectiveness of Trivandrum Developmental Screening Chart (TDSC) items based intervention package developed at Child Development Centre, Kerala on the developmental outcome of children at 18 mo of age using Developmental Assessment Scale for Indian Infants (DASII) and compare the same in different birth weight groups. METHODS: Five hundred consecutive discharges from the Neonatal Intensive Care Unit (NICU), Sree Avittam Thirunal hospital, were recruited and followed up till 18 mo of age including 240 low birth weight (LBW;<2,500 g) babies and 260 normal birth weight babies. All 240 LBW babies were offered early intervention at monthly intervals till 12 mo of age, whereas the normal birth weight (NBW) group received only immunization service as per the routine of the hospital. The early intervention package for the low birth weight group was designed based on Trivandrum Developmental Screening Chart (TDSC 0-2 y) items delay. At 18 mo of age both the groups were offered developmental assessment using DASII by specially trained and experienced developmental therapists who were blind to the intervention status of the babies. RESULTS: It was observed that the LBW (<2,500 g) group, who received intervention had a DASII mental age of 18.31 as against 18.16 in the NBW (≥2,500 g) group and mental DQ 101.84 (LBW group) and 98.65 (NBW group) and the observed differences were not statistically significant. Similarly, the LBW, who received intervention group had a DASII motor age of 18.68 as against 18.47 in the NBW group and motor DQ 139.40 (LBW group) and 135.39 (NBW group) and the observed differences were not statistically significant. CONCLUSIONS: The results of this TDSC based intervention package among low birth weight babies showed that at 18 mo of age there was no statistically significant difference in the developmental outcome using DASII, between low birth weight babies on intervention and the normal birth weight babies without any intervention.

CDC Kerala 6: Validation of Language Evaluation Scale Trivandrum (0-3 y) against Receptive Expressive Emergent Language Scale in a developmental evaluation clinic population.

OBJECTIVE: To validate Language Evaluation Scale Trivandrum (LEST) 0-3 y against the reference standard, Receptive Expressive Emergent Language Scale (REELS) in a population of children attending CDC developmental evaluation clinic 0-3 y. METHODS: All the children clinically diagnosed as having speech and language problem in the developmental evaluation clinic of CDC Kerala over a period of 3 y were assessed using LEST (0-3) by trained developmental therapist and REELS by a speech therapist, both blind to the results of each other. RESULTS: Out of a total of 761 children between 0-3 y diagnosed as having speech problems by a Developmental Pediatrician in the developmental evaluation clinic (0-3 y) of CDC Kerala, both LEST and REELS could be administered among 679 children. The screening tool LEST 0-3 had a high sensitivity (84.4%), specificity (80.3%), Positive Predictive Value (PPV) (91.5%), Negative Predictive Value (NPV) (67.1%) and accuracy (83.2%) against the reference standard REELS. CONCLUSIONS: The observation of this study that LEST 0-3 had a high sensitivity, specificity and accuracy against REELS, suggest that in a developmental/speech evaluation clinic LEST could be effectively used in resource poor settings.

CDC Kerala 9: Effectiveness of low intensity home based early intervention for autism spectrum disorder in India.

OBJECTIVE: To validate effectiveness of low intensity, home based early intervention (EI) models in autism for countries with low disability resources. METHODS: Fifty-two toddlers and young children were assessed before and after intervention with Childhood Autism Rating Scale, Vineland Social Maturity Scale, and Receptive-Expressive Emergent Language Scale. Developmental and speech therapists helped mothers assemble low-cost training kits based on the developmental age of the child, gave initial training in the basic behavioral technique to address the three autism symptom clusters at home. Follow-up support was given either on a weekly, fortnightly or monthly basis. Most of the children were also placed in play-schools. Data was analyzed using appropriate bivariate and multivariate techniques. RESULTS: There was statistical and clinical amelioration in the severity of autism, with acquisition of social skills and language skills (all P = 0.001) after intervention in children with mild to severe autism. Gender showed a trend in becoming a significant predictor for intervention response. CONCLUSIONS: Low-intensity, home-based EI can be effectively used in situations where there is paucity of disability resources in countries like India, especially in primary-care and community settings.

CDC Kerala 3: At-risk baby clinic service using different screening tools--outcome at 12 months using Developmental Assessment Scale for Indian Infants.

OBJECTIVES: To describe CDC Kerala experience of establishing an at-risk baby clinic and the comparison of different developmental screening tools at 12 mo against the gold standard Developmental Assessment Scale for Indian Infants (DASII). METHODS: At risk baby clinic of CDC, Kerala was established as a facility for follow up of NICU graduates from Sree Avittam Thirunal Hospital at 2, 4, 6, 8 and 12 mo corrected age and during each visit the mother is taught the CDC model early stimulation by developmental therapists and encouraged to continue to do the same at home. At 12 mo, assessment results of four simple developmental tools were compared with the gold standard DASII administered by a senior developmental therapist. RESULTS: Out of a total of 800 babies, outcome measurements at 12 mo were available for 604 infants. The prevalence of developmental delay using the screening tools, CDC grading for standing, Amiel Tison angles and DDST II (Denver II) gross motor were 24.8, 24 and 24.3% respectively and using DASII, a diagnostic tool (13.3%). Also the combination of Amiel Tison angles, CDC standing grading and DDST gross motor against DASII motor DQ had high specificity (94.15%) and negative predictive value (NPV) (70.18%) but with a very low sensitivity of 14.58% and low positive predictive value (PPV) of 53.85%. It was observed that a significant odds ratio for DASII mental deviation quotient (DQ) was seen for neonatal seizures (2.34) and low birth weight (1.49). CONCLUSION: The prevalence of developmental delay using the screening tools, CDC grading for standing, Amiel Tison angles and DDST II (Denver II) gross motor were 24.8, 24 and 24.3% respectively and together they had a high specificity, NPV and accuracy against DASII motor DQ as gold standard at one year assessment.

CDC Kerala 5: Developmental therapy clinic experience--use of Child Development Centre grading for motor milestones.

OBJECTIVES: To document the experiences of the intervention given to children who attended the developmental therapy clinic of Child Development Centre (CDC) Kerala, a specialized clinic for providing developmental intervention/therapy for babies less than two years with developmental delay/disability. METHODS: All the babies referred to this speciality clinic from developmental screening/evaluation clinics of CDC were registered in the clinic and re-evaluation was done using CDC grading for head holding, sitting, standing, Amiel Tison passive angles, and Trivandrum Developmental Screening Chart (TDSC) 0-2 y. RESULTS: Out of a total of 600 consecutive babies below 2 y with developmental delay/disability referred to developmental therapy clinic, on comparing the test results at enrollment and after 6 mo of intervention, a statistically significant reduction was observed (i) in the 2-4 mo age group with regard to abnormal TDSC (25.5%), (ii) in the 4-8 mo age group with regard to abnormal head holding grade (87.1%) and abnormal TDSC (19.4%), (iii) in the 8-12 mo age group, with regard to abnormal sitting grade (71.7%) and (iv) in the above 12 mo age group with regard to abnormal sitting grade (35.3%) and abnormal standing grade (78.8%). CONCLUSIONS: The experience of organizing the developmental intervention/therapy clinic at CDC Kerala has shown that therapy services by developmental therapists in a centre and supportive therapy by mother at home is useful in improving the developmental status of children with developmental delay.