Child and Parent-directed Individualized Psychotherapy (CPIP)

Child Neglect Clinical Trial

— AMIS-II-RCT  

Official title:

Randomized Controlled Trial of Child and Parent-directed Individualized Psychotherapy (CPIP) for Neglected Children With Internalizing Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05128669
• Other study ID #: AMIS-II-RCT
• Secondary ID: 01KR1802A
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: March 20, 2025

Study information

• Verified date: June 2023
• Source: University of Leipzig
• Contact: Lars Otto White, Dr. phil
• Phone: +49 (0) 341 - 9724018
• Email: LarsOtto.White[@]medizin.uni-leipzig.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Setting: Typically, 25 weekly sessions of approximately 50 minutes; in the clinician's office, family home, or child protection service office (due to the limited compliance expected from some families to attend regular therapeutic sessions). When conducting treatment sessions in the home environment, principles of established and evidence-based home visitation programs, like SafeCare or Nurse-Family Partnership Program will be applied. Therapeutic elements: Reflective developmental guidance, modeling appropriate emotional availability, understanding of the meaning and function of the symptoms within relationships together with the caregivers, identifying and labeling feelings and actions, creation of a "neglect narrative" (parallel to a trauma narrative) and conflict interpretation together with the child. Three treatment phases: Session 1-5: Building of a working alliance, assessment of family/individual problems and resources, focus formulation; Sessions 6-20: Therapeutic work on the focus; Session 21 to 25: Detachment of the working alliance, summarizing, concluding, fostering future development. Therapeutic strategy: The inner conflict which is currently most pressing and actively determining the child's symptoms as well as jeopardizing mental development in the present will be identified and formulated during the first 5 sessions together with the caregivers and the child (therapeutic "focus"). The following treatment phase concentrates on the jointly identified problem/conflict that has been aggregated in the focus formulation. The setting will vary (number of parent-only, child-only, and caregiver-child sessions) as a function of whether the focus predominantly lies in the interpersonal (caregiver-child interaction) or intrapersonal realm. Control Condition: 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, the investigators 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. the investigators will compare children receiving CPIP plus ECS to children receiving ECS only.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 20, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Child Neglect

Intervention

Procedure:
• CPIP
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.
• ECS
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.

Locations

Country	Name	City	State
Germany	University of Leipzig - Department of Child and Adolescent Psychiatry	Leipzig
Germany	Klinikum Rechts der Isar der Technischen Universität München- Lehrstuhl für Sozialpädiatrie	München

Sponsors (4)

Lead Sponsor	Collaborator
University of Leipzig	Medical School Hamburg, Technical University of Munich, Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	caregiver-rated internalizing symptoms for mid/long-term effects	Caregiver-rated IntS using Child Behavior Checklist (CBCL 4-18) at t4 to assess mid/long-term effects. The scale ranges from 0-62 with higher scores indicating worse outcomes.	13 months after randomisation
Secondary	internalizing symptoms in clinical interviews	IntS for depression and anxiety assessed using the Preschool Age Psychiatric Assessment (PAPA), administered to caregivers by trained Masters-level staff	within 4 weeks before randomisation + 7 and 13 months after randomisation
Secondary	teacher-rated internalizing symptoms	(Nursery-)teacher-rated IntS using Teacher Report Form (TRF 4-18). The scale ranges from 0-70 with higher scores indicating worse outcomes.	within 4 weeks before randomisation + 7 and 13 months after randomisation
Secondary	secondary caregiver-rated internalizing symptoms	Secondary caregiver-rated IntS using Child Behavior Checklist (CBCL 4-18). The scale ranges from 0-62 with higher scores indicating worse outcomes.	within 4 weeks before randomisation + 7 and 13 months after randomisation
Secondary	child-rated internalizing symptoms	Child self-reported internalizing symptoms using Berkeley Puppet Interview. The scale ranges from 1-182 with higher scores indicating better outcomes.	within 4 weeks before randomisation + 7 and 13 months after randomisation
Secondary	Externalizing symptoms	Externalizing symptoms (ExtS) rated by caregivers and teachers using the Child Behavior Checklist (CBCL 4-18), Teacher-report Form (TRF) and Berkeley Puppet Interview, respectively.; The CBCL ExtS scale ranges from 0-66 with higher scores indicating worse outcomes. The TRF ExtS scale ranges from 0-68 with higher scores indicating worse outcomes.	within 4 weeks before randomisation + 7 and 13 months after randomisation
Secondary	Cognitive-emotional style/mentalizing capacity	In an exploratory fashion, the investigators will test whether the child's ability to mentalize improve after the intervention and whether improvement in this ability is a mediator of the treatment effect.; Child's ability to mentalize assessed by the Process Scales (Hill et al., 2009) and the MacArthur Narrative Coding Manual (MNCM; Robsinson et al., 2002) using the indices for narrative coherence (range: 1-12), intentionality (range: 1-12), with higher scores indicating better outcome.	within 4 weeks before randomisation + 7 months after randomisation
Secondary	Quality of the parent-child interaction (EAS)	In an exploratory fashion, the investigators will test whether the quality of parent-child interaction improve after the intervention and whether this improvement in interaction quality is a mediator of the treatment effect.; Quality of the parent-child interaction assessed by the Emotional Availability Scales (EAS), specifically four caregiver scales (1. sensitivity, 2. structuring, 3. nonintrusiveness, and 4. nonhostility) and two child scales (1.responsiveness to mother and 2. involvement of mother). Codes on the scales range from 1 to 7, with higher scores indicating better outcome.	within 4 weeks before randomisation + 7 months after randomisation
Secondary	Cortisol secretion	hair cortisol concentrations (HCC) in the first 3 cm scalp hair segment at posterior vertex (~cumulative secretion over last 3 months)	within 4 weeks before randomisation + 3.5 months after randomisation + 7 and 13 months after randomisation
Secondary	Polygenic epigenetic risk scores	changes in DNA methylation profiles	within 4 weeks before randomisation + 7 months after randomisation
Secondary	Adherence to CPIP interventions	number of sessions attended by primary caregiver and by child for secondary/sensitivity analyses	7 months after randomisation
Secondary	Feasibility-related endpoints - Acceptability of CPIP rated by caregivers/ parents	Acceptability of CPIP rated by caregivers/ parents using Treatment evaluation questionnaire (Fragebogen zur Beurteilung der Behandlung - FBB)	7 months after randomisation
Secondary	Feasibility-related endpoints - Acceptability of CPIP rated by children	Acceptability of CPIP rated by children: Items derived from the German version of Therapeutic Alliance Scales for Children (TASC)	7 months after randomisation
Secondary	Feasibility-related endpoints - Acceptability of CPIP rated by therapists	Acceptability of CPIP rated by caregivers/ parents using Treatment evaluation questionnaire (Fragebogen zur Beurteilung der Behandlung - FBB)	7 months after randomisation
Secondary	Feasibility-related endpoints - CPIP retention rates	Acceptability of CPIP - retention rates. We expect a high rate of retention until end of the intervention.	7 months after randomisation
Secondary	Feasibility-related endpoints - Adherence to CPIP interventions	Adherence to CPIP interventions: coding of session videos using a Q-sort rating	7 months after randomisation