Mona Katharina Sprengeler1, Janna Mattheß2, Melanie Eckert2, Katharina Richter2,3, Gabriele Koch2, Thomas Reinhold3, Petra Vienhues4, Anne Berghöfer3, Julia Fricke3, Stephanie Roll3, Thomas Keil3,5,6, Christiane Ludwig-Körner2, Lars Kuchinke7, Kai von Klitzing8, Franziska Schlensog-Schuster8. 1. Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, University of Leipzig, Liebigstrasse 20a, 04103, Leipzig, Germany. mona.sprengeler@medizin.uni-leipzig.de. 2. International Psychoanalytic University Berlin, Berlin, Germany. 3. Institute of Social Medicine, Epidemiology, and Health Economics, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany. 4. Fachklinik für Psychiatrie, Psychosomatik und Psychotherapie, DIAKO Nordfriesland, Flensburg, Germany. 5. Institute for Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany. 6. State Institute of Health, Bavarian Health and Food Safety Authority, Bad Kissingen, Germany. 7. Psychological Methods and Evaluation, International Psychoanalytic University Berlin, Berlin, Germany. 8. Department of Child and Adolescent Psychiatry, Psychotherapy and Psychosomatics, University of Leipzig, Liebigstrasse 20a, 04103, Leipzig, Germany.
Abstract
BACKGROUND: The first years of life are a significant period for child development, when children are particularly sensitive and prone to crises. This early phase lays the foundation for healthy growth. Clinical assessment of psychological symptoms in early infancy and adequate treatment are both important in improving the diagnostic outcome and preventing later long-term developmental consequences. The most common psychological problems in the first 3 years of life are regulatory disorders. The aim of this trial is to investigate the efficacy of Parent-Infant Psychotherapy (PIP) for infants and young children (aged 0-36 months, diagnosed with at least one regulatory disorder) and their mothers, compared to care as usual (CAU). METHODS: In this open multicentre randomised controlled trial, 160 mother-infant dyads are randomised to receive PIP or CAU for 6 weeks of intervention in clinical or outpatient (including home treatment) settings. The primary outcome is the maternal sensitivity (sensitivity scale of the Emotional Availability Scales (EAS)) after 6 weeks. Secondary outcomes include assessment of interaction, mental health problems, attachment, development, psychological factors, treatment adherence, health care system utilisation, and costs, after 6 weeks and 12 months. DISCUSSION: This study will evaluate whether a manualised focus-based short-term psychodynamic psychotherapeutic intervention in mother-child dyads improves the care situation for families of children diagnosed with regulatory disorders, and helps prevent long-term psychopathologies. Assessment of the intervention in different settings will support the development of more tailored interventions for affected infants and their mothers. TRIAL REGISTRATION: German Clinical Trial Register, ID: DRKS00017008 . Registered 03/20/2019.
RCT Entities:
BACKGROUND: The first years of life are a significant period for child development, when children are particularly sensitive and prone to crises. This early phase lays the foundation for healthy growth. Clinical assessment of psychological symptoms in early infancy and adequate treatment are both important in improving the diagnostic outcome and preventing later long-term developmental consequences. The most common psychological problems in the first 3 years of life are regulatory disorders. The aim of this trial is to investigate the efficacy of Parent-Infant Psychotherapy (PIP) for infants and young children (aged 0-36 months, diagnosed with at least one regulatory disorder) and their mothers, compared to care as usual (CAU). METHODS: In this open multicentre randomised controlled trial, 160 mother-infant dyads are randomised to receive PIP or CAU for 6 weeks of intervention in clinical or outpatient (including home treatment) settings. The primary outcome is the maternal sensitivity (sensitivity scale of the Emotional Availability Scales (EAS)) after 6 weeks. Secondary outcomes include assessment of interaction, mental health problems, attachment, development, psychological factors, treatment adherence, health care system utilisation, and costs, after 6 weeks and 12 months. DISCUSSION: This study will evaluate whether a manualised focus-based short-term psychodynamic psychotherapeutic intervention in mother-child dyads improves the care situation for families of children diagnosed with regulatory disorders, and helps prevent long-term psychopathologies. Assessment of the intervention in different settings will support the development of more tailored interventions for affected infants and their mothers. TRIAL REGISTRATION: German Clinical Trial Register, ID: DRKS00017008 . Registered 03/20/2019.
Entities:
Keywords:
Clinical assessment; Early childhood; Focus-based psychodynamic intervention; Infant psychopathology; Manualised short-term psychotherapy; Maternal sensitivity; Mental health
Authors: Charles H Zeanah; Alice S Carter; Julie Cohen; Helen Egger; Mary Margaret Gleason; Miri Keren; Alicia Lieberman; Kathleen Mulrooney; Cindy Oser Journal: Infant Ment Health J Date: 2016-08-29
Authors: J Mattheß; M Eckert; K Richter; G Koch; T Reinhold; P Vienhues; A Berghöfer; S Roll; T Keil; F Schlensog-Schuster; K von Klitzing; C Ludwig-Körner; L Kuchinke Journal: Trials Date: 2020-06-05 Impact factor: 2.279