Trial document





This trial has been registered retrospectively.
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  DRKS00005739

Trial Description

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Title

The efficacy of a brief parent-infant psychotherapy for the treatment of early regulatory disorders: A randomized controlled trial

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Trial Acronym

Effectivenessstudy SKEPT

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URL of the Trial

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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.

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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.

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Organizational Data

  •   DRKS00005739
  •   2014/03/19
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  •   yes
  •   Approved
  •   S-541/2013, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1154-1059 
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Health Condition or Problem studied

  •   F43.2 -  Adjustment disorders
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Interventions/Observational Groups

  •   Psychodynamic and relationship-focused infant-toddler-parent psychotherapy (sessions of 1x 90 min. and 3x 50 min. with infants and parents) during the intervention period of twelve weeks
  •   Treatment as usual in pediatric praxis during the intervention period of twelve weeks
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Average Time (in min.) of observed crying/fussing-, sleeping-, and feeding episodes (based on 24h diaries filled out for four consecutive days by PapouĊĦek, Rothenburg, Cierpka & von Hofacker, 2004) after twelve weeks of intervention and in the catamnesis after twelve months. Difficulties concerning the regulation of crying, sleeping and feeding (Questionnaire for Crying, Feeding and Sleeping by Groß, Reck, Thiel-Bonney & Cierpka, 2013) after twelve weeks of intervention. Behavioral difficulties of the child (Child Behavior Checklist 1 ½ - 5 by Arbeitsgruppe Kinder-, Jugend- und Familiendiagnostik, 2002) and in the catamnesis after twelve months. Diagnoses of sleep-onset or night-waking disorder according to DC: 0-3 (2005) in the catamnesis after twelve months.

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Secondary Outcome

Subjective burden of parents regarding the upbringing and care of their child (Parental-Stress-Index by Tröster, 2011) after twelve weeks of intervention and in the catamnesis after twelve months. Severity of parental depressive symptoms (Depression scale, Symptom-Checklist-90R-S by Franke, 2013) after twelve weeks of intervention and in the catamnesis after twelve months. Parent’s emotional availability in observed parent-child-interactions (Emotional Availability Scales 4th by Biringen, 2008) after twelve weeks of intervention. Parental self-efficacy (Maternal Self-Efficacy Questionnaire by Teti & Gelfand, 1991) after twelve weeks of intervention and in the catamnesis after twelve months. Parental reflective functioning (Parental Reflective Functioning Questionnaire by Luyten, Mayes, Nijssens & Fonagy) after twelve weeks of intervention and in the catamnesis after twelve months. Severity of parental general psychopathology (Global Severity Index, SCL-90R-S by Franke, 2013) after twelve weeks of intervention and in the catamnesis after twelve months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2014/02/03
  •   160
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   16   Weeks
  •   60   Weeks
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Additional Inclusion Criteria

organically healthy; singleton; born at or after 37 weeks gestational age; mother speaking sufficently german; meeting diagnostic criteria for DC: 0-3 R (regulation disorder of sensory processing, sleep behavior disorder, feeding behavior disorder)

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Exclusion Criteria

pediatric suspicion of fetal alcohol syndrome; disability and/or pervasive developmental disorder; parents reporting severe psychopatholic symptoms (SCL-90R-S, T ≥ 70)

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Addresses

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Sources of Monetary or Material Support

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    • Vereinigung Analytischer Kinder- und Jugendlichen-Psychotherapeuten
    • Mr.  Jörn  Gleiniger 
    • Kurfürstendamm 72
    • 10709  Berlin
    • Germany
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    • Heidehof Stiftung GmbH
    • Ms.  Erna  Schneider 
    • Heidehofstr. 35 A
    • 70184  Stuttgart
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.