Individualized psychotherapy for children with internalizing disorders and neglect
Randomized Controlled Trial of Child and Parent-directed Individualized Psychotherapy (CPIP) for Neglected Children With Internalizing Disorders
This study is testing a new therapy for children aged 3 to 8 who have emotional issues and have faced neglect to see if it helps them feel better compared to regular treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 3 Years to 8 Years |
| Sex | All |
| Sponsor | University of Leipzig Academic / other |
| Locations | 2 sites (Leipzig and 1 other locations) |
| Trial ID | NCT05128669 on ClinicalTrials.gov |
What this trial studies
This study evaluates a manualized modular psychotherapy called Child and Parent-directed Individualized Psychotherapy (CPIP) designed for children aged 3 to 8 who have internalizing disorders and have experienced emotional or physical neglect. The intervention focuses on enhancing caregiver-child interactions and employs mentalization-based techniques to address the child's internal conflicts. Treatment sessions will occur in various settings, including the clinician's office, family home, or child protection service office, and will consist of 25 weekly sessions. The study aims to determine if CPIP, combined with enhanced caregiving support, is more effective than standard care in reducing internalizing symptoms in children.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 8 who have been diagnosed with an internalizing disorder and have experienced emotional or physical neglect.
Not a fit: Patients with severe language barriers, unresolved custody disputes, or those currently undergoing intensive psychotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve emotional and psychological outcomes for children suffering from neglect and internalizing disorders.
How similar studies have performed: Previous studies have shown promise in using similar therapeutic approaches for children with emotional and behavioral issues, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion criteria for registration: * Age 3 to 8 * Sufficiently stable psychosocial situation of the child for potential participation in the study * Written informed consent of the patient's parents or legal guardian * Informed oral consent of children (from 6 years) * Release from professional secrecy Teacher / educator * Positive pre-screening for internalizing symptoms * Inclusion criteria for randomisation: * Confirmation that the child's psychosocial situation is sufficiently stable to participate in the study * physical/emotional neglect * DSM-5 internalizing disorder Exclusion Criteria: * Exclusion criteria for registration: * limited language skills of children or caregivers (caregiver: if communication severely impeded despite translators) * unresolved custody dispute * concurrent intensive psychotherapy of \>3 months duration * participation of the child in other interventional trials * Exclusion criteria for randomisation: * IQ \< 70 * autism or psychosis/schizophrenia spectrum disorder of the child
Where this trial is running
Leipzig and 1 other locations
- University of Leipzig - Department of Child and Adolescent Psychiatry — Leipzig, Germany (Recruiting)
- Klinikum Rechts der Isar der Technischen Universität München- Lehrstuhl für Sozialpädiatrie — München, Germany (Recruiting)
Study contacts
- Study coordinator: Lars Otto White, Dr. phil
- Email: LarsOtto.White@medizin.uni-leipzig.de
- Phone: +49 (0) 341 - 9724018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.