UnknownNot Applicable

Child and Parent-directed Individualized Psychotherapy (CPIP)

Germany200 participantsStarted 2020-07-21

Plain-language 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.

Who can participate

Age range3 Years – 8 Years

SexALL

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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

What they're measuring

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

Trial details

NCT IDNCT05128669

SponsorUniversity of Leipzig

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-20

Contact for this trial

Lars Otto White, Dr. phil

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