Effect of parenting intervention through “Care for Child Development Guideline” on early child development and behaviors: a randomized controlled trial

This randomized controlled trial was approved by the ethics committee of Isfahan University of Medical Sciences (ID: IR.MUI.RESEARCH.REC.1397.092), registered in the Iranian Registry of Clinical Trials (IRCT20190128042533N2, Date of registration: 16/01/2020) and has therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. It was conducted from February 2020 to February 2021 at an outpatient public Pediatrics clinic in Isfahan, Iran. To calculate the sample size, we used the equation for comparing two means with a type I error of 1.96 and a power of 0.90. Assumptions in two groups (including effect size equal to 0.40) were pre-specified based on previously published data [20‐22] and the expected effect was hypothesized as a clinically meaningful effect. The sample size was calculated as at least 133 participants in each group. However, due to the COVID-19 pandemic and social restrictions, we stopped the study when 228 participants enrolled. We included Iranian pregnant women aged 18–45 years in their third trimester (days 196 to 280 of pregnancy) who had a healthy fetus based on clinical and ultrasound evaluations, then we followed their children for 18 months. We excluded participants who were absent for more than 2 educational sessions, refused to continue the study, as well as those who had a child with congenital anomaly, birth asphyxia, seizure, or known metabolic or neurological disorders after birth.

The study protocol was explained to participants and written informed consent was obtained from participants. Overall, 210 pregnant women were included. Random numbers were generated by random allocation software in binary blocks, and the pediatric neurologist assigned participants into intervention or control groups of equal numbers. The intervention group underwent 5 educational group sessions, each lasting for almost 45 minutes. The sessions were held during the third trimester of pregnancy (the first session), and then 2–6 weeks, 2–6 months, 6–9 months, and 9–12 months after delivery. The educational content of each session was adopted from the Persian version of the Care for Child Development (CCD)-2012 manual (Table 1) [23]. In the intervention group, mothers were trained on how to play and communicate with their children based on the children’s age. We used training materials including educational slides, videos, counseling cards, and toys. Parents engaged in play and communication activities to encourage their children’s learning, according to CCD recommendations. They also learn how to be sensitive to the needs of children and respond appropriately to address their needs through play and communication. The training sessions were held in groups with 20 participants by a pediatric neurologist who was trained by the Iranian Ministry of Health and Medical Education. The control group underwent routine education on child care, suggested by WHO, which is currently implemented in most of the primary health care centers in the country by using pamphlets, as well as general skills training sessions such as sessions on breastfeeding encouragement.

The main outcome of the present study was the children’s development at 12 months of age. Moreover, based on our literature review, after the trial registration, we decided to follow up the children’s socio-emotional behavior at 18 months of age. We examined children’s development in 3 key developmental domains of cognition, language, and motor by the Bayley Scales Of Infant and Toddler Development-III (BSID-III) test. It was validated in Persian and the reliability was assessed using Cronbach’s alpha for internal consistency (cognition (r = 0.79), language (receptive communication (r = 0.76), expressive communication (r = 0.81)), motor (fine motor (r = 0.80), and gross motor scales (r = 0.81))). The standardized Persian version of this questionnaire did not include the other 2 domains of social-emotional and adaptive of the English version of BSID-III [24]. In our study, the test was performed by a certified healthcare provider, who was trained by the Iranian Ministry of Health and Medical Education as one of the staff for performing the BSID-III test in Iran. We also assessed children’s socio-emotional behaviors by CBCL/1½–5, which was developed by Achenbach [25]. It consists of 99 closed items that are rated as not true (score 0), somewhat/sometimes true (score 1), or very true/often true (score 2) and one open-ended item. Mothers completed the Persian version of CBCL [26, 27], normalized and translated by Mohammad Esmaeel [28]. In addition to a total problem score, CBCL contains 2 broadband scales (externalizing problems and internalizing problems) and 8 narrowband syndrome scales including emotionally reactive, anxiety/depression, somatic complaints, withdrawal, sleep problems, attention problems, aggressive behavior, and other problems. The latter involves a range of heterogeneous problems including jealousy, disobedience, food refusal, overeating, being overweight, nail-biting, nightmares, etc. DSM-V scales include affective problems, anxiety problems, pervasive developmental problems, attention-deficit/ hyperactivity problems, and oppositional defiant problems.

Good test-retest reliability was found with correlation coefficients ranging from 0.37 to 0.91 for each item. The average test-retest reliability coefficients for the total competence score and the total problems score were 0.80 and 0.79, respectively [29]. In the test re-test analyses conducted by Achenbach et al. [29] with a two-week interval, a test-retest coefficient of 0.87 was reported for behavioral problems.

Sociodemographic data were collected from the mothers in both groups at the time of enrollment. The number of children, educational level of parents, parental ages, their income, history of paternal smoking, infant’s gender, Apgar scores, gestational age, and delivery type were collected.

Continuous variables were expressed as mean ± standard deviation (SD), and categorical data as numbers (percentages). We assessed the normality of data by statistical (by the Kolmogorov–Smirnov test) and graphical tests (Box- plots). Comparisons between means of continuous variables in the intervention and control groups were performed using an independent Student t-test. We used the Chi-square test to assess the difference in the distribution of the categorical variables between intervention and control groups. We calculated the adjusted median and the mean differences between the intervention and control groups by median regression and linear regression models, respectively. The regression models were performed for each domain of BSID-III assessment and CBCL, separately. The models were adjusted for maternal and paternal age and educational levels, paternal cigarette smoking, preterm labor, type of delivery, and child’s gender. We selected the covariates based on a review literature. All analyses followed per-protocol principles. Data analyses were performed using the statistical software STATA 12.0 (STATA Corp, College Station, Texas, USA). P-values of less than 0.050 were considered statistically significant.

The means/medians for all scores were more than 100 in both intervention and control groups. The adjusted median differences between intervention and control groups using median regression were not significant for all BSID-III domains except for cognitive score (β (SE): − 4.98(2.31), p:0.032). We also provided the results of the linear regression and we found no significant differences in cognitive, language and motor scores of BSID-III between the two groups (Table 3).

The adjusted median differences between intervention and control groups using median regression were not significant for any CBCL syndrome scales. The adjusted mean differences between intervention and control groups using linear regression were not significant for all CBCL syndrome scales except for anxiety/depression score(β (SE): − 2.54(1.27), p:0.046) (Table 4).

There are some limitations to the present study that may have affected our findings. First and foremost, the main limitation is that children’s developmental scores based on BSID-III were probably at the ceiling, leaving little room for improvement. BSID scores are from a norm-referenced assessment of early childhood development. Although the selection of neurotypical children might cause an increase in the mean scores, the differences in cultural, environmental, and genetic factors might also influence development. Our sample may not be representative of Iran and may be dissimilar to other parenting evaluations; for example, almost half of our mothers were university-educated. Second, too little time was spent in sessions due to the restrictions we had during the COVID-19 crisis. Third, although we approached to follow up all participants in, we lost a considerable number due to the COVID-19 outbreak. Many mothers in the intervention group were not willing to participate in the sessions anymore because of social distancing rules. It is well documented that parents who accept to participate in parenting programs are different than the ones who do not participate [38]. This issue affects the representability of the study sample, so the result should be interpreted with caution. Fourth, we were not able to assess parents’ knowledge before and after the intervention, and their adherence to CCD instructions due to the limited resources. Measuring parenting practices assessing by some standard tools such as the HOME [39] would also benefit our findings. Fifth, in this study, we just involved mothers in group sessions. Despite the observational evidence that fathers are critically important for ECD [40], we could not involve fathers in our parenting program due to their work time as well as low compliance for the study. The last limitation was that caregivers in the intervention group could have been biased in reporting on their child’s behavior in the CBCL assessment. Therefore, this should be considered when interpreting the findings of the present study. Despite these limitations, this study has focused on children’s behavior during infancy and early childhood. Most parenting programs for behavioral development to date have been commonly delivered to preschool-aged children rather than young children during the earliest years of life and our information on early childhood was scarce [18, 41‐43]. Moreover, we represented the child’s socio-emotional behavior through a valid and reliable tool, while several previous studies reported no details regarding the reliability or validity of the measurement tool for behavioral problems [19]. Another strength of the current study is its novelty in developing countries and the first study of its kind in the region.