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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00005739

Enrollment

160

Registered

2014-03-19

Start date

2014-02-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F43.2

Interventions

Group 1: 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 Grou

Eligibility

Sex/Gender

All

Age

16 Weeks to 60 Weeks

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Average Time (in min.) of observed crying/fussing-, sleeping-, and feeding episodes (based on 24h diaries filled out for four consecutive days by Papoušek, 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.	—

Measure

Time frame

Average Time (in min.) of observed crying/fussing-, sleeping-, and feeding episodes (based on 24h diaries filled out for four consecutive days by Papoušek, 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.

—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Contacts

Public ContactAnna Georg

Institut für Psychosoziale PräventionUniversitätsklinikum Heidelberg

anna.georg@med.uni-heidelberg.de06221 565662

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 25, 2026