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 range

3 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Child Neglect trials