Child and Parent-directed Individualized Psychotherapy (CPIP) (AMIS-II-RCT)

University of Leipzig

Status: Enrolling

Conditions: Child Neglect; Internalizing Disorder

Treatments: Procedure: ECS; Procedure: CPIP

Study type: Interventional

Funder types: Other

Identifiers

NCT05128669

AMIS-II-RCT

01KR1802A (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

CPIP+ECS

Experimental group

Description:

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.

Treatment:

Procedure: CPIP

Procedure: ECS

ECS only

Active Comparator group

Description:

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.

Treatment:

Procedure: ECS