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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Background: After the birth of a child, many mothers and fathers experience postpartum mental disorders like depression, anxiety, obsessive-compulsive disorder, stress or other illnesses. This endangers the establishment of a secure attachment between the children and their primary caregivers. Early problems in parent-child interaction can have adverse long-term effects on the family and the child's well-being. In order to prevent a transgenerational transmission of mental disorders, it is necessary to evaluate psychotherapeutic interventions that target psychologically burdened parents of infants or toddlers. The aim of this trial is to investigate the efficacy of Parent-Infant-Psychotherapy (PIP) for mothers with postpartum mental disorder and their infants (0-12 months). Methods/design: In this open, randomized controlled intervention trial 180 mother-infant-dyads will be included and randomly allocated to 12 sessions of PIP or care as usual. The interventions take place either in inpatient adult psychiatric departments or in outpatient settings with home visits. The primary outcome is the change in maternal sensitivity assessed by the Sensitivity subscale of the Emotional Availability Scale (EAS) through videotaped dyadic play-interactions after 6 weeks. Secondary outcomes are maternal psychopathology, stress, parental reflective functioning, infant development and attachment after 6 weeks and 12 months. In addition, maternal attachment (AAI) and reflective functioning (AAI) will be analyzed as potential moderators, and resource usage in the German health system as well as associated costs will be evaluated. Discussion: There is increasing demand for well-controlled studies on psychotherapeutic interventions in the postpartum period that do not only focus on particular risk groups. This randomized controlled trial (RCT) represents one of the first studies to investigate the efficacy of PIP in inpatient psychiatric departments and outpatient care centers in Germany. The results will fill knowledge gaps on the factors contributing to

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Background Psychotherapy of mother-child dyads is an intervention which was developed to prevent maltreatment and negative children’s development. There is a lack of good-quality research investigating psychotherapeutic interventions and social care for mothers at high-risk living in Mother-Child Facilities in Germany. The present randomized controlled pilot trial (RCT) aimed to evaluate the need for parent-infant psychotherapy (PIP) and to explore its impact on the mother-infant relationship. Primary feasibility objectives were recruitment and attrition, with potential efficacy defined as the secondary feasibility objective. Methods This pilot RCT focused on (young) mothers with cumulative risk factors and their infants under 7 months of age living in Mother-Child Facilities. N=32 mother-child dyads were randomly allocated to PIP or Care as usual (CAU). Outcomes were assessed at baseline, 3 months, and 6 months of intervention. The primary potential efficacy outcome was maternal sensitivity. Secondary outcomes were maternal mental health problems, reflective functioning, parenting stress, personality organization, infant’s development, and attachment. Results At baseline, all mothers showed low levels of emotional availability, but results revealed improvements in sensitivity, mental health problems, stress, and depressive symptomatology favoring PIP after 6 months. Positive developments in maternal sensitivity, a healthy aspect of mother-child interaction, were only found in the PIP group. Overall attrition was high at 6 months. Some evidence of fewer depressive symptoms and lower maternal distress after 6 months of PIP-intervention exists that did not reach significance. Conclusion Findings revealed improvements in the mother’s well-being for both groups, but PIP had a higher impact on the mother-child dyad. In sum, there is some evidence that PIP may represent an effective intervention offer besides the social and pedagogical support in these facilities, but further research is demanded. Trial registration DRKS00022485 (retrospectively registered).