Child NeglectAMIS-II-RCTNCT05128669
Child and Parent-directed Individualized Psychotherapy (CPIP)
A study testing CPIP and ECS in people with Child Neglect and Internalizing Disorder, run by University of Leipzig at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Child Neglect, Internalizing Disorder
- What is being tested?
- CPIP and ECS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- 21 Jul 2020to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 9Show fewer
- Confirmation that the child's psychosocial situation is sufficiently stable to participate in the study
- physical/emotional neglect
- DSM-5 internalizing disorder
Who cannot join
- 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
- IQ < 70
- autism or psychosis/schizophrenia spectrum disorder of the child
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University of Leipzig - Department of Child and Adolescent Psychiatry
Leipzig, 04103
Kai von Klitzing, Prof. Dr.
- Recruiting
Klinikum Rechts der Isar der Technischen Universität München- Lehrstuhl für Sozialpädiatrie
München, 81675
Volker Mall, Prof.Dr.
About this study
Official title: Randomized Controlled Trial of Child and Parent-directed Individualized Psychotherapy (CPIP) for Neglected Children With Internalizing Disorders
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:
Read more
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.
Read the 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.
- Conditions
- Child Neglect, Internalizing Disorder
- Being tested
- CPIP, ECS
- Keywords
- emotional/physical neglect, Internalizing disorders, 3 to 8-year old children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPIPProcedure or surgery
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.
ECSProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| CPIP+ECS | Experimental | 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. Receives: Procedure: CPIP; Procedure: ECS |
| ECS only | Active comparator | 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. Receives: Procedure: ECS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The primary efficacy endpoint is taken 13 months after randomisation
Secondary outcomes (16)
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.
Measured: 13 months after randomisation
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
Measured: within 4 weeks before randomisation + 7 and 13 months after randomisation
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.
Measured: within 4 weeks before randomisation + 7 and 13 months after randomisation
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.
Measured: within 4 weeks before randomisation + 7 and 13 months after randomisation
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.
Measured: within 4 weeks before randomisation + 7 and 13 months after randomisation
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.
Measured: within 4 weeks before randomisation + 7 and 13 months after randomisation
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.
Measured: within 4 weeks before randomisation + 7 months after randomisation
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.
Measured: within 4 weeks before randomisation + 7 months after randomisation
Cortisol secretion
hair cortisol concentrations (HCC) in the first 3 cm scalp hair segment at posterior vertex (~cumulative secretion over last 3 months)
Measured: within 4 weeks before randomisation + 3.5 months after randomisation + 7 and 13 months after randomisation
Polygenic epigenetic risk scores
changes in DNA methylation profiles
Measured: within 4 weeks before randomisation + 7 months after randomisation
Adherence to CPIP interventions
number of sessions attended by primary caregiver and by child for secondary/sensitivity analyses
Measured: 7 months after randomisation
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)
Measured: 7 months after randomisation
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)
Measured: 7 months after randomisation
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)
Measured: 7 months after randomisation
Feasibility-related endpoints - CPIP retention rates
Acceptability of CPIP - retention rates. We expect a high rate of retention until end of the intervention.
Measured: 7 months after randomisation
Feasibility-related endpoints - Adherence to CPIP interventions
Adherence to CPIP interventions: coding of session videos using a Q-sort rating
Measured: 7 months after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start21 Jul 2020
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child NeglectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 arms, randomized assignment to intervention group (CPIP + ECS) or control group (ECS only), single masked (outcomes assessor), multi-centre trial
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Dresden, Medical School Hamburg, Technical University of Munich
- Responsible party
- Principal investigator, Lars White, University of Leipzig
- Investigators
- Kai von Klitzing, Prof. Dr., Study chair, University of Leipzig, Child and Adolescent Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128669
- Sponsor's protocol ID
- AMIS-II-RCT
- Other IDs
- 01KR1802A
- Acronym
- AMIS-II-RCT
- Status last verified
- Jun 2023
- First submitted
- 11 Jan 2021
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of the primary objective, published data might be provided to interested scientists on request (e.g. for meta-analyses, health related registers or other scientific questions) in an anonymized way within 5 years, if the members of the AMIS-II-trial group agree.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Child and Parent-directed Individualized Psychotherapy (CPIP) for Neglected Children With Internalizing Disorders
- ClinicalTrials.gov ID
- NCT05128669
- Acronym / sponsor ID
- AMIS-II-RCT / AMIS-II-RCT
- Conditions
- Child Neglect, Internalizing Disorder
- Keywords
- emotional/physical neglect, Internalizing disorders, 3 to 8-year old children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Technische Universität Dresden, Medical School Hamburg, Technical University of Munich
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Mar 2025 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 arms, randomized assignment to intervention group (CPIP + ECS) or control group (ECS only), single masked (outcomes assessor), multi-centre trial
| Arm | Type | Receives |
|---|---|---|
| CPIP+ECS | Experimental | Procedure: CPIP, Procedure: ECSCPIP 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. |
| ECS only | Active comparator | Procedure: ECSEnhanced 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. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
Key exclusion criteria (6 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPIPCPIP 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. | Procedure or surgery | CPIP+ECS |
| ECSEnhanced 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. | Procedure or surgery | CPIP+ECS, ECS only |
Primary outcome
Assess superiority of CPIP in addition to Enhanced Caregiving Support (ECS) as compared to ECS alone.
Time frame: The primary efficacy endpoint is taken 13 months after randomisation
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.
16 secondary outcomes
caregiver-rated internalizing symptoms for mid/long-term effects
Time frame: 13 months after randomisation
internalizing symptoms in clinical interviews
Time frame: within 4 weeks before randomisation + 7 and 13 months after randomisation
teacher-rated internalizing symptoms
Time frame: within 4 weeks before randomisation + 7 and 13 months after randomisation
secondary caregiver-rated internalizing symptoms
Time frame: within 4 weeks before randomisation + 7 and 13 months after randomisation
child-rated internalizing symptoms
Time frame: within 4 weeks before randomisation + 7 and 13 months after randomisation
Externalizing symptoms
Time frame: within 4 weeks before randomisation + 7 and 13 months after randomisation
Cognitive-emotional style/mentalizing capacity
Time frame: within 4 weeks before randomisation + 7 months after randomisation
Quality of the parent-child interaction (EAS)
Time frame: within 4 weeks before randomisation + 7 months after randomisation
Cortisol secretion
Time frame: within 4 weeks before randomisation + 3.5 months after randomisation + 7 and 13 months after randomisation
Polygenic epigenetic risk scores
Time frame: within 4 weeks before randomisation + 7 months after randomisation
Adherence to CPIP interventions
Time frame: 7 months after randomisation
Feasibility-related endpoints - Acceptability of CPIP rated by caregivers/ parents
Time frame: 7 months after randomisation
Feasibility-related endpoints - Acceptability of CPIP rated by children
Time frame: 7 months after randomisation
Feasibility-related endpoints - Acceptability of CPIP rated by therapists
Time frame: 7 months after randomisation
Feasibility-related endpoints - CPIP retention rates
Time frame: 7 months after randomisation
Feasibility-related endpoints - Adherence to CPIP interventions
Time frame: 7 months after randomisation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Yes. After publication of the primary objective, published data might be provided to interested scientists on request (e.g. for meta-analyses, health related registers or other scientific questions) in an anonymized way within 5 years, if the members of the AMIS-II-trial group agree.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai von Klitzing, Prof. Dr. study chair
University of Leipzig, Child and Adolescent Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPIP and ECS in people with Child Neglect and Internalizing Disorder, run by University of Leipzig at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Otto White, Dr. phil (+49 (0) 341 - 9724018, LarsOtto.White@medizin.uni-leipzig.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess superiority of CPIP in addition to Enhanced Caregiving Support (ECS) as compared to ECS alone. (time frame: The primary efficacy endpoint is taken 13 months after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023.