Child and Parent-directed Individualized Psychotherapy (CPIP)

NCT05128669 | Unknown DMC

• 2 other identifiers: AMIS-II-RCT01KR1802A
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

With CPIP the investigators opt for a manualized modular psychotherapy designed especially to meet the needs of children with internalizing disorders that suffered or still suffer from emotional or physiological neglect. CPIP helps the child to resolve rigid conflictual internal representations/ working models by individually focusing on caregiver-child interaction, mentalization based interventions with children and caregivers and working with the therapeutic transference relationship with the child and the caregiver. Treatment sessions will take place at CAP. Clinical hypotheses: The main hypothesis of the study is that for children with internalizing disorders and experience of emotional / physical neglect, CPIP \& enhanced caregiving support (intervention group) is superior in reducing internalizing symptoms compared to ECS alone (control group). Potential predictors of treatment response, as family context, gender and age, will be examined. Furthermore, the investigators will investigate possible treatment effects and mediating mechanisms, especially changes in DNA methylation profiles, HPA-dysregulation, cognitive-emotional styles, and emotional availability. Additional elements: If the child additionally suffers from traumatic experiences of violence or sexual abuse, elements of Tf-CBT will be applied. Furthermore, elements of Interaction Guidance and ABC including video feedback will be applied in joint caregiver-child sessions. Treatment fidelity: Following the previous study, manualization, careful training and regular supervision will strive to ensure high treatment fidelity which will be systematically assessed in a random sample of two videotaped sessions per family.

Conditions

Child Neglect; Internalizing Disorder

Keywords

emotional/physical neglect; Internalizing disorders; 3 to 8-year old children

Outcome Measures

Primary Outcomes (1)

• Assess superiority of CPIP in addition to Enhanced Caregiving Support (ECS) as compared to ECS alone.

  We assume superiority of CPIP \& ECS compared to ECS alone in reducing internalizing symptoms of participating children. The Child Behavior Checklist 4-18 (CBCL 4-18) - a well-established internationally used questionnaire that reliably and validly captures child internalizing symptoms. The primary efficacy endpoint (pEP) is the CBCL 4-18 internalizing symptoms score (IntS), rated by the primary caregiver at t3 (post-treatment). The scale ranges from 0-62 with higher scores indicating worse outcomes.

  The primary efficacy endpoint is taken 13 months after randomisation

Secondary Outcomes (16)

• caregiver-rated internalizing symptoms for mid/long-term effects

  13 months after randomisation

• internalizing symptoms in clinical interviews

  within 4 weeks before randomisation + 7 and 13 months after randomisation

• teacher-rated internalizing symptoms

  within 4 weeks before randomisation + 7 and 13 months after randomisation

• secondary caregiver-rated internalizing symptoms

  within 4 weeks before randomisation + 7 and 13 months after randomisation

• child-rated internalizing symptoms

  within 4 weeks before randomisation + 7 and 13 months after randomisation

Study Arms (2)

CPIP+ECS

EXPERIMENTAL

CPIP is an innovative Child-Parent Individualized Psychotherapy, consisting of 25 sessions, designed by the PI and his clinical collaborators for children with internalizing disorders in the aftermath of childhood neglect. It is informed by Short-term Psychoanalytic Child Therapy (PaCT), elements of psychoanalytic parent work, videofeedback and Child-Parent Psychotherapy (CPP) and. CPIP supports the child-caregiver relationship and helps the child to resolve rigid conflictual internal representations/working models and improve interpretative and mentalizing techniques. ECS (Enhanced Caregiving Support) is described in other arm.

Procedure: CPIP; Procedure: ECS

ECS only

ACTIVE COMPARATOR

Enhanced Caregiving Support (ECS) will serve as the control condition provided by the Allgemeine Sozialdienst (ASD - Community Social Services) of the two participating cities. According to German law (§ 27 SGB VIII), caregivers are entitled to receive caregiving support (CS; "Hilfe zur Erziehung") in cases where the child's wellbeing is jeopardized. CS generally includes supportive work across all child-relevant systems (family, neighborhood, (pre-)school, peer group etc.). Appointed social workers and educators provide parenting counseling, family support, and intensive child support according to an individualized helping plan ("Hilfeplan"). In more severe cases, children are placed in (temporary) day-care centers, children's homes, foster families etc. Within the context of the trial, we will appoint an additional multi-systemic case manager to each case to enhance the quality of case coordination (enhanced CS; ECS). All children and families will receive ECS.

Procedure: ECS

Interventions

CPIP PROCEDURE

CPIP is an innovative Child-Parent Individualized Psychotherapy, consisting of 25 sessions, designed by the PI and his clinical collaborators for children with internalizing disorders in the aftermath of childhood neglect. It is informed by Short-term Psychoanalytic Child Therapy, elements of psychoanalytic parent work, videofeedback and Child-Parent Psychotherapy (CPP) and. CPIP supports the child-caregiver relationship and helps the child to resolve rigid conflictual internal representations/working models and improve interpretative and mentalizing techniques.

CPIP+ECS

ECS PROCEDURE

Enhanced Caregiving Support (ECS) will serve as the control condition provided by the Allgemeine Sozialdienst (ASD - Community Social Services) of the two participating cities. According to German law (§ 27 SGB VIII), caregivers are entitled to receive caregiving support (CS; "Hilfe zur Erziehung") in cases where the child's wellbeing is jeopardized. CS generally includes supportive work across all child-relevant systems (family, neighborhood, (pre-)school, peer group etc.). Appointed social workers and educators provide parenting counseling, family support, and intensive child support according to an individualized helping plan ("Hilfeplan"). In more severe cases, children are placed in (temporary) day-care centers, children's homes, foster families etc. Within the context of the trial, we will appoint an additional multi-systemic case manager to each case to enhance the quality of case coordination (enhanced CS; ECS). All children and families will receive ECS.

CPIP+ECS; ECS only

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Confirmation that the child's psychosocial situation is sufficiently stable to participate in the study
• physical/emotional neglect
• DSM-5 internalizing disorder

You may not qualify if:

• 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
• IQ \< 70
• autism or psychosis/schizophrenia spectrum disorder of the child

Sponsors & Collaborators

• University of Leipzig: lead
• Technische Universität Dresden: collaborator
• Medical School Hamburg: collaborator
• Technical University of Munich: collaborator

Study Sites (2)

University of Leipzig - Department of Child and Adolescent Psychiatry

Leipzig, 04103, Germany

RECRUITING

Klinikum Rechts der Isar der Technischen Universität München- Lehrstuhl für Sozialpädiatrie

München, 81675, Germany

RECRUITING

MeSH Terms

Interventions

prostaglandin-inositol cyclic phosphate

Study Officials

• Kai von Klitzing, Prof. Dr.

  University of Leipzig, Child and Adolescent Psychiatry

  STUDY CHAIR

Central Study Contacts

Lars Otto White, Dr. phil

CONTACT

+49 (0) 341 - 9724018; LarsOtto.White@medizin.uni-leipzig.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 2 arms, randomized assignment to intervention group (CPIP + ECS) or control group (ECS only), single masked (outcomes assessor), multi-centre trial

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: November 22, 2021
• Study Start: July 21, 2020
• Primary Completion: December 20, 2024
• Study Completion: March 20, 2025
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: after publication within 5 years
• Access Criteria: direct inquiry to coordinating investigators

Locations

DE (2)