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BMC Psychiatry
Published in: BMC Psychiatry 1/2021

Open Access 01-12-2021 | Psychotherapy | Study protocol

Efficacy of parent-infant psychotherapy compared to care as usual in children with regulatory disorders in clinical and outpatient settings: study protocol of a randomised controlled trial as part of the SKKIPPI project

Authors: Mona Katharina Sprengeler, Janna Mattheß, Melanie Eckert, Katharina Richter, Gabriele Koch, Thomas Reinhold, Petra Vienhues, Anne Berghöfer, Julia Fricke, Stephanie Roll, Thomas Keil, Christiane Ludwig-Körner, Lars Kuchinke, Kai von Klitzing, Franziska Schlensog-Schuster

Published in: BMC Psychiatry | Issue 1/2021

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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.
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Metadata
Title
Efficacy of parent-infant psychotherapy compared to care as usual in children with regulatory disorders in clinical and outpatient settings: study protocol of a randomised controlled trial as part of the SKKIPPI project
Authors
Mona Katharina Sprengeler
Janna Mattheß
Melanie Eckert
Katharina Richter
Gabriele Koch
Thomas Reinhold
Petra Vienhues
Anne Berghöfer
Julia Fricke
Stephanie Roll
Thomas Keil
Christiane Ludwig-Körner
Lars Kuchinke
Kai von Klitzing
Franziska Schlensog-Schuster
Publication date
01-12-2021
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2021
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-021-03112-6

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