Clinical trial NCT05128669: Child and Parent-directed Individualized Psychotherapy (CPIP)
Official title: Randomized Controlled Trial of Child and Parent-directed Individualized Psychotherapy (CPIP) for Neglected Children With Internalizing Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Neglect
Internalizing Disorder
Keywords: emotional/physical neglect
Internalizing disorders
3 to 8-year old children
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Technische Universität Dresden
name: Medical School Hamburg
name: Technical University of Munich
First posted: 2021-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms, randomized assignment to intervention group (CPIP + ECS) or control group (ECS only), single masked (outcomes assessor), multi-centre trial
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Assess superiority of CPIP in addition to Enhanced Caregiving Support (ECS) as compared to ECS alone.
timeFrame: The primary efficacy endpoint is taken 13 months after randomisation
Secondary outcomes:
measure: caregiver-rated internalizing symptoms for mid/long-term effects
timeFrame: 13 months after randomisation
measure: internalizing symptoms in clinical interviews
timeFrame: within 4 weeks before randomisation + 7 and 13 months after randomisation
measure: teacher-rated internalizing symptoms
timeFrame: within 4 weeks before randomisation + 7 and 13 months after randomisation
measure: secondary caregiver-rated internalizing symptoms
timeFrame: within 4 weeks before randomisation + 7 and 13 months after randomisation
measure: child-rated internalizing symptoms
timeFrame: within 4 weeks before randomisation + 7 and 13 months after randomisation
measure: Externalizing symptoms
timeFrame: within 4 weeks before randomisation + 7 and 13 months after randomisation
measure: Cognitive-emotional style/mentalizing capacity
timeFrame: within 4 weeks before randomisation + 7 months after randomisation
measure: Quality of the parent-child interaction (EAS)
timeFrame: within 4 weeks before randomisation + 7 months after randomisation
measure: Cortisol secretion
timeFrame: within 4 weeks before randomisation + 3.5 months after randomisation + 7 and 13 months after randomisation
measure: Polygenic epigenetic risk scores
timeFrame: within 4 weeks before randomisation + 7 months after randomisation
measure: Adherence to CPIP interventions
timeFrame: 7 months after randomisation
measure: Feasibility-related endpoints - Acceptability of CPIP rated by caregivers/ parents
timeFrame: 7 months after randomisation
measure: Feasibility-related endpoints - Acceptability of CPIP rated by children
timeFrame: 7 months after randomisation
measure: Feasibility-related endpoints - Acceptability of CPIP rated by therapists
timeFrame: 7 months after randomisation
measure: Feasibility-related endpoints - CPIP retention rates
timeFrame: 7 months after randomisation
measure: Feasibility-related endpoints - Adherence to CPIP interventions
timeFrame: 7 months after randomisation
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig - Department of Child and Adolescent Psychiatry
city: München
country: Germany
facility: Klinikum Rechts der Isar der Technischen Universität München- Lehrstuhl für Sozialpädiatrie
Study officials:
affiliation: University of Leipzig, Child and Adolescent Psychiatry
name: Kai von Klitzing, Prof. Dr.
role: STUDY_CHAIR
References: