German Clinical Trials Register

Acronym/abbreviation of the study

Effectivenessstudy SKEPT

URL of the study

No Entry

Brief summary in lay language

Early childhood regulatory disorders refer to an infant’s or toddler’s extraordinary difficulty to properly regulate its behavior in at least one interaction context. Among the most common regulatory disturbances are excessive screaming, sleep-onset and night-waking disorder as well as feeding-behavior disorder. The frequency of such regulatory problems in the first year of life is estimated to be about 20%. In approximately half the cases the children’s difficulties are only of transient nature and disappear on their own. However, severe, persistent or multiple regulatory difficulties can lead to an increased level of parental stress and the manifestation of interactional difficulties. This, in turn, can strongly influence the child’s development and lead to emotional and behavioral problems far beyond the toddler age. Therefore the investigation of early preventive and interventional programs is needed. The aim of the present study is to investigate the effectiveness of the psychodynamic and relationship-focused infant-toddler-parent psychotherapy (SKEPT) targeting regulation disorders in the fields of crying, sleeping and feeding. The effectiveness of the short-term intervention is compared with the effectiveness of the regular pediatric treatment. Participants of the study are children, 16-60 weeks of age, who are being presented at cooperating pediatricians in the region of Heidelberg because of regulatory symptoms. After extensive diagnostic investigation the participants are randomly assigned to the treatment by SKEPT or the treatment by the pediatrician. Objective of the study is to test the effect of the treatment on the child’s symptoms, the parent-child interaction, and the parental burden in the upbringing and care of the child as well as the general parental psychopathology, especially on depression, and finally the impact on parental self-efficacy. For this purpose data is collected using questionnaires, behavioral diaries, and videotaped interactions between parents and child before and after the treatment period of twelve weeks. Twelve months after the end of treatment the long-term effects are tested through the examination of the child’s symptoms, the parental burden regarding the upbringing and care of the child as well as the general parental psychopathology, especially depression, and finally the parental self-efficacy and parental reflective functioning. Twelve months after the end of treatment the long-term effects are tested through the examination of the child’s symptoms, the parental burden regarding the upbringing and care of the child as well as the general parental psychopathology, especially depression, and finally the parental self-efficacy and parental reflective functioning. Amendment on 07.07.2014: Lower age restriction changed to 4 months. Reason: clinical experience gained through the cooperation with paediatricians; enlargement of sample size.

Brief summary in scientific language

Early childhood regulatory disorders such as excessive screaming, sleep-onset and night-waking disorder as well as feeding behavior disorder occur frequently in the first year of life. Severe, persistent or multiple regulatory difficulties can lead to an increased level of parental stress and the manifestation of interactional difficulties. This, in turn, can strongly influence the child’s development and lead to emotional and behavioral problems far beyond the toddler age. Therefore, the investigation of early preventive and interventional programs is needed. Randomized controlled studies investigating the effectiveness of such programs are, however, very rare. The aim of the present RCT study is to investigate the effectiveness of the psychodynamic and relationship-focused infant-toddler-parent psychotherapy (SKEPT) targeting regulation disorders in the fields of crying, sleeping and feeding. The effectiveness of the short-term intervention is compared with the effectiveness of the regular pediatric treatment (TAU). Participants of the study are children, 16-60 weeks of age, who are being presented at cooperating pediatricians in the region of Heidelberg because of regulatory symptoms. After extensive diagnostic investigation the participants are randomly assigned to the treatment with SKEPT (n = 80) or the treatment by the pediatrician (n = 80). The manualized treatment conducted by psychotherapists using SKEPT includes four sessions (first session á 90 minutes and 2nd-4th session á 50 minutes) in the course of twelve weeks. The treatment by the pediatrician is documented case-related in order to control the effect of dose (number and duration of visits), different treatment elements, and the degree of specific training of the pediatrician in post-[hoc] analyses. Moreover, information about additional health-care-service providers consulted by the parents during the course of the study is gathered. The investigation of the effectiveness of the two treatments is done through the use of questionnaires, behavioral diaries and videotaped interactions between parents and child before (t1) and after (t2) the treatment period of twelve weeks. Primary outcome variables are the symptoms of the child operationalized by the duration of cry/fussing, sleep and feeding episodes on four consecutive days as well as the experienced difficulties in behavioral regulation of the child rated by the parents. Secondary outcome variables are the emotional availability of the parents in parent-child interaction, parental burden in the upbringing and care of the child as well as the general parental psychopathology, especially depression, and finally parental self-efficacy and parental reflective functioning. Another object of investigation is the treatment satisfaction of parents in both conditions. Twelve months after the end of treatment (t3) the long-term effects are tested through the examination of the child’s symptoms, the parental burden regarding the upbringing and care of the child as well as the general parental psychopathology, especially depression, and finally the parental self-efficacy and parental reflective functioning. An additional subject of the catamnesis is the use of social and professional support in both groups. The title of the study has been adapted according to the new name of the program.