The Impact of an Interactive Guidance Intervention on Sustained Social Withdrawal in Preterm Infants in Chile: Randomized Controlled Trial

Background: Sustained social withdrawal is a key indicator of child emotional distress and a risk factor for psychological development. Preterm infants have a higher probability of developing sustained social withdrawal than infants born full-term during their first year. Objective: To compare the effect of a behavioral guidance intervention to that of routine pediatric care on sustained social withdrawal behavior in preterm infants. Design: Multicenter randomized clinical trial. Participants: Ninety nine moderate and late preterm newborns and their parents were recruited and randomized into two groups, i.e., Intervention (n = 49) and Control (n = 50). Both groups attended medical check-ups at 2, 6 and 12 months and were assessed with the Alarm Distress Baby Scale. The intervention group received a standardized behavioral intervention if the neonatologist detected sustained social withdrawal. Also, parents filled out the Edinburgh Postnatal Depression Scale, the modified-Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale-revised. Results: At baseline, the prevalence of withdrawal was 4.0% (95% CI: 0.03–14.2) for the control group and 22.4% (95% CI: 13.0–35.9) for the intervention group [OR = 0.22, p = 0.028 (95% CI =0.06–0.84)]. At 6 months, the prevalence was 10.0% (95% CI: 3.9–21.8) for the control group and 6.1% (95% CI: 2.1–16.5) for the intervention group [OR = 2.09, p = 0.318 (95% CI = 0.49–8.88)]. At 12 months, the prevalence was 22.0% (95% CI: 12.8–35.2) for the control group and 4.1% (95% CI: 1.1–13.7) for the intervention group [OR = 6.63, p = 0.018 (95% CI = 1.39–31.71)]. Logistic generalized estimating equation models were performed. The pooled crude OR (considering diagnosis at 6 and 12 months) was 3.54 [p = 0.022 (95% CI = 1.20–10.44); Cohen's d= 0.70]. In the case of pooled adjusted OR, the model considered diagnosis (0 = Withdrawal, 1 = Normal) as the dependent variable, time of evaluation (1= 6 months, 2 = 12 months) and group (0 = Control, 1 = Experimental) as factors. In this case, the pooled adjusted OR was 3.57 [p = 0.022 (95% CI = 1.20–10.65); Cohen's d = 0.70]. Conclusion: Assessment and intervention of sustained social withdrawal in preterm infants via standardized instruments benefits families by reducing its prevalence, and possible associated negative outcomes. Clinical Trial Registration: ClinicalTrials.gov; https://clinicaltrials.gov/ct2/show/NCT03212547, identifier: NCT03212547.