Child AbuseNCT04519229
Child-Parent Psychotherapy - a Feasibility Study for Children in Foster Care
An observational study of Child Abuse and Child Neglect, run by Kronoberg County Council at 1 site in Sweden.
Trial summary
Children in foster care have an increased risk of exposure to adverse experiences during childhood and across the lifespan. In current studies of interventions children in foster care are often excluded, or they are too few to be included in statistical analyses of outcomes. Read more about this study
- Who is it for?
- Ages 0 to 6 years
- Conditions the study is for
- Child Abuse, Child Neglect, Post-Traumatic Stress Disorder in Children
- What is being tested?
- Child-Parent Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 30 Jun 2019to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children in foster care offered Child-Parent Psychotherapy at any of the nine participating agencies.
Who may be able to join
- Age 0-6 years
- being offered Child-Parent Psychotherapy as part of their regular treatment
Who cannot join
- Families in need of translator for interviews.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site
Department of Research and Development, Region Kronoberg
Vaxjo, 35112
About this study
Official title: Child-Parent Psychotherapy for Children 0-6 Years Old With Experiences of Adverse Life Events - a Feasibility Study for Children in Foster Care
Children in foster care have an increased risk of exposure to adverse experiences during childhood and across the lifespan. In current studies of interventions children in foster care are often excluded, or they are too few to be included in statistical analyses of outcomes. As a consequence, knowledge on feasibility of treatment methods for some of the most exposed and maltreated children in society is sparse.
Child-Parent Psychotherapy (CPP) is an intervention for children 0-6 years who have been exposed to adverse and traumatic events. CPP is currently being implemented in Sweden. The aim of this study is to investigate the feasibility of CPP for children in foster care.
Read the detailed description
Aim. The aim of the current study is to investigate the feasibility of CPP for young children who have an increased risk of exposure to adverse and traumatic experiences with negative effects on their health and development. Feasibility will be conceptualized as acceptance of the method by therapists, caregivers, and children; practical applications of the method; any need for modifications; and observed outcomes.
Research questions The main research question is: Is CPP feasible for children in foster care? Additional research questions are: 1) How do children in foster care experience participating in CPP? 2) How do foster parents experience participating in CPP? 3) How do clinicians experience using CPP with children in foster care and their caregivers? 4) What outcomes can be observed in treatment with children in foster care in terms of increased psychological health in children and foster parents; decrease in symptoms of post-traumatic stress in children and foster parents; and foster parents' experiences of their caregiving capacity and relationship with the child.
Method Design. The project has a naturalistic mixed-methods study design. Qualitative and quantitative research methods will be used to collect and analyze data. Qualitative data concerning childrens', caregivers', and clinicians' experiences of the treatment method as well as quantitative data concerning practical applications of the method, any modifications made, and reported levels of symptoms will be studied.
Participants. Nine agencies in different regions of Sweden offering CPP as part of their regular services have accepted to participate in the study. Participants are consecutively recruited at the participating agencies. Inclusion will be terminated when 20 children have been included (whereof at least 12 children aged 3-6 years).
Procedure. At treatment start caregivers and custodians (this can include foster parents, social services, and biological parents) will be informed about the study and asked for consent to participate. Because of their low age children aged 3-6 will be informed and asked for consent to participate in connection to the interviews. Quantitative data will be collected by self-report instruments completed by the foster parents before treatment and after 20 sessions or at termination, if treatment if terminated earlier. Participation, fidelity, and modifications are registered by clinicians continuously. Foster parents and clinicians will be asked to schedule interviews by one of the researchers in the project after 20 sessions or at termination, if treatment if terminated earlier.
Background information. Demographical and background data will be collected using a form designed for this purpose, before treatment and after 20 sessions or at termination, if treatment is terminated earlier.
Instrument. Qualitative interviews focusing acceptance and experiences of the method will be conducted with children, foster parents, and clinicians. The interviews will be conducted by child psychologists experienced in clinical treatment as well as in research with families with young children in in difficult life situations. The interviews will be recorded and transcribed verbatim. Clinicians will register participation, fidelity, and any modifications after each treatment session in a log-book. Quantitative data on outcome concerning exposure, symptoms of post-traumatic stress, psychological health, and caregiving experiences will be collected by self-report instruments completed by foster parents before treatment and after 20 sessions or at termination, if treatment is terminated earlier.
Analyses. The interviews will be analyzed by thematic analysis or interpretative phenomenological analysis, according to the applicability in relation to the research questions and data collected. Descriptive statistical methods will be used to describe exposure, symptoms pre- and post-treatment, and treatment modifications made. Non-parametric statistical methods will be used to analyze and describe indications concerning outcome.
- Conditions
- Child Abuse, Child Neglect, Post-Traumatic Stress Disorder in Children, Parent-Child Relations
- Being tested
- Child-Parent Psychotherapy
- Keywords
- Children, Adverse childhood events, Post traumatic stress, Children in foster care, Psychotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child-Parent PsychotherapyBehavioural
Relationship-based trauma focused psychotherapy for Children 0-6 years old and their caregivers. The objective is to decrease symptoms of post-traumatic tress and re-establish a secure attachment for the child and good caregiving from the caregiver/s.
| Study group | Role | What they receive |
|---|---|---|
| Children in fostercare in CPP-treatment | Children in foster care taking part in Child-Parent Psychotherapy Receives: Behavioral: Child-Parent Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline score on the Strengths and Difficulties Questionnaire - Parent version at 20 completed sessions or at termination of intervention if terminated earlier.
Caregiver report of child psychopathology. Minimum score 0, maximum score 40, higher score indicating worse outcome.
Measured: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Change from baseline score on the Trauma Symptom Checklist for Young Children at 20 completed sessions or at termination of intervention if terminated earlier.
Caregiver report of child symptoms of post-traumatic stress. Minimum score 90, maximum score 360, higher score indicating worse outcome.
Measured: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Change from baseline score on the Linköping Youth Life Experiences Scale at 20 completed sessions or at termination of intervention if terminated earlier.
Caregiver report of child exposure to traumatic and adverse life events. Minimum score 0, maximum score 41, higher score indicating worse outcome.
Measured: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Change from baseline score on the Child-Parent Psychotherapy Symptom Screener at 20 completed sessions or at termination of intervention if terminated earlier.
Caregiver report of child symptoms of post-traumatic reactions. Minimum score 0, maximum score 93, higher score indicating worse outcome.
Measured: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Secondary outcomes (4)
Change from baseline score on the Hopkins Symptom Check List-25 at 20 completed sessions or at termination of intervention if terminated earlier.
Caregiver report of psychological distress and symptoms. Minimum score 0, maximum score 100, higher score indicating worse outcome.
Measured: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Change from baseline score on the Impact of Event Scale-Revised at 20 completed sessions or at termination of intervention if terminated earlier.
Caregiver report of symptoms of post-traumatic stress. Minimum score 0, maximum score 80, higher score indicating worse outcome.
Measured: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Change from baseline score on the Life Incidence of Traumatic Events Questionnaire at 20 completed sessions or at termination of intervention if terminated earlier.
Caregiver report of exposure to traumatic and adverse life events. Minimum score 0, maximum score 41, higher score indicating worse outcome.
Measured: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Change from baseline score on the Caregiving Helplessness Questionnaire at 20 completed sessions or at termination of intervention if terminated earlier.
Caregiver report on caregiving experiences. Minimum score 18, maximum score 90, higher score indicating worse outcome.
Measured: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start30 Jun 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child AbuseStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kronoberg County Council
- Sponsor type
- Other government
- Collaborators
- Stiftelsen Allmänna Barnhuset
- Responsible party
- Sponsor
- Investigators
- Karin Pernebo, PhD, Study director, Department of Psychology, Linnaeus University, Sweden and Department of Research and Development, Region Kronoberg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519229
- Sponsor's protocol ID
- RK/30062020
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2020
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child-Parent Psychotherapy for Children 0-6 Years Old With Experiences of Adverse Life Events - a Feasibility Study for Children in Foster Care
- ClinicalTrials.gov ID
- NCT04519229
- Acronym / sponsor ID
- RK/30062020
- Conditions
- Child Abuse, Child Neglect, Post-Traumatic Stress Disorder in Children, Parent-Child Relations
- Keywords
- Children, Adverse childhood events, Post traumatic stress, Children in foster care, Psychotherapy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kronoberg County CouncilOther government
- Collaborators
- Stiftelsen Allmänna Barnhuset
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Aug 2020 (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.
Children in foster care have an increased risk of exposure to adverse experiences during childhood and across the lifespan. In current studies of interventions children in foster care are often excluded, or they are too few to be included in statistical analyses of outcomes. As a consequence, knowledge on feasibility of treatment methods for some of the most exposed and maltreated children in society is sparse.
Child-Parent Psychotherapy (CPP) is an intervention for children 0-6 years who have been exposed to adverse and traumatic events. CPP is currently being implemented in Sweden. The aim of this study is to investigate the feasibility of CPP for children in foster care.
Detailed description
Aim. The aim of the current study is to investigate the feasibility of CPP for young children who have an increased risk of exposure to adverse and traumatic experiences with negative effects on their health and development. Feasibility will be conceptualized as acceptance of the method by therapists, caregivers, and children; practical applications of the method; any need for modifications; and observed outcomes.
Research questions The main research question is: Is CPP feasible for children in foster care? Additional research questions are: 1) How do children in foster care experience participating in CPP? 2) How do foster parents experience participating in CPP? 3) How do clinicians experience using CPP with children in foster care and their caregivers? 4) What outcomes can be observed in treatment with children in foster care in terms of increased psychological health in children and foster parents; decrease in symptoms of post-traumatic stress in children and foster parents; and foster parents' experiences of their caregiving capacity and relationship with the child.
Method Design. The project has a naturalistic mixed-methods study design. Qualitative and quantitative research methods will be used to collect and analyze data. Qualitative data concerning childrens', caregivers', and clinicians' experiences of the treatment method as well as quantitative data concerning practical applications of the method, any modifications made, and reported levels of symptoms will be studied.
Participants. Nine agencies in different regions of Sweden offering CPP as part of their regular services have accepted to participate in the study. Participants are consecutively recruited at the participating agencies. Inclusion will be terminated when 20 children have been included (whereof at least 12 children aged 3-6 years).
Procedure. At treatment start caregivers and custodians (this can include foster parents, social services, and biological parents) will be informed about the study and asked for consent to participate. Because of their low age children aged 3-6 will be informed and asked for consent to participate in connection to the interviews. Quantitative data will be collected by self-report instruments completed by the foster parents before treatment and after 20 sessions or at termination, if treatment if terminated earlier. Participation, fidelity, and modifications are registered by clinicians continuously. Foster parents and clinicians will be asked to schedule interviews by one of the researchers in the project after 20 sessions or at termination, if treatment if terminated earlier.
Background information. Demographical and background data will be collected using a form designed for this purpose, before treatment and after 20 sessions or at termination, if treatment is terminated earlier.
Instrument. Qualitative interviews focusing acceptance and experiences of the method will be conducted with children, foster parents, and clinicians. The interviews will be conducted by child psychologists experienced in clinical treatment as well as in research with families with young children in in difficult life situations. The interviews will be recorded and transcribed verbatim. Clinicians will register participation, fidelity, and any modifications after each treatment session in a log-book. Quantitative data on outcome concerning exposure, symptoms of post-traumatic stress, psychological health, and caregiving experiences will be collected by self-report instruments completed by foster parents before treatment and after 20 sessions or at termination, if treatment is terminated earlier.
Analyses. The interviews will be analyzed by thematic analysis or interpretative phenomenological analysis, according to the applicability in relation to the research questions and data collected. Descriptive statistical methods will be used to describe exposure, symptoms pre- and post-treatment, and treatment modifications made. Non-parametric statistical methods will be used to analyze and describe indications concerning outcome.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children in fostercare in CPP-treatment | – | Behavioral: Child-Parent PsychotherapyChildren in foster care taking part in Child-Parent Psychotherapy |
Who may qualify
- Ages
- 0 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children in foster care offered Child-Parent Psychotherapy at any of the nine participating agencies.
Key inclusion criteria (2 listed)
- Age 0-6 years
- being offered Child-Parent Psychotherapy as part of their regular treatment
Key exclusion criteria (1 listed)
- Families in need of translator for interviews.
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 |
|---|---|---|
| Child-Parent PsychotherapyRelationship-based trauma focused psychotherapy for Children 0-6 years old and their caregivers. The objective is to decrease symptoms of post-traumatic tress and re-establish a secure attachment for the child and good caregiving from the caregiver/s. | Behavioural | Children in fostercare in CPP-treatment |
Primary outcome
Change from baseline score on the Strengths and Difficulties Questionnaire - Parent version at 20 completed sessions or at termination of intervention if terminated earlier.
Time frame: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Caregiver report of child psychopathology. Minimum score 0, maximum score 40, higher score indicating worse outcome.
Change from baseline score on the Trauma Symptom Checklist for Young Children at 20 completed sessions or at termination of intervention if terminated earlier.
Time frame: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Caregiver report of child symptoms of post-traumatic stress. Minimum score 90, maximum score 360, higher score indicating worse outcome.
Change from baseline score on the Linköping Youth Life Experiences Scale at 20 completed sessions or at termination of intervention if terminated earlier.
Time frame: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Caregiver report of child exposure to traumatic and adverse life events. Minimum score 0, maximum score 41, higher score indicating worse outcome.
Change from baseline score on the Child-Parent Psychotherapy Symptom Screener at 20 completed sessions or at termination of intervention if terminated earlier.
Time frame: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Caregiver report of child symptoms of post-traumatic reactions. Minimum score 0, maximum score 93, higher score indicating worse outcome.
4 secondary outcomes
Change from baseline score on the Hopkins Symptom Check List-25 at 20 completed sessions or at termination of intervention if terminated earlier.
Time frame: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Change from baseline score on the Impact of Event Scale-Revised at 20 completed sessions or at termination of intervention if terminated earlier.
Time frame: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Change from baseline score on the Life Incidence of Traumatic Events Questionnaire at 20 completed sessions or at termination of intervention if terminated earlier.
Time frame: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Change from baseline score on the Caregiving Helplessness Questionnaire at 20 completed sessions or at termination of intervention if terminated earlier.
Time frame: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Karin Pernebo, PhD study director
Department of Psychology, Linnaeus University, Sweden and Department of Research and Development, Region Kronoberg, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Abuse and Child Neglect, run by Kronoberg County Council at 1 site in Sweden.
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 2 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline score on the Strengths and Difficulties Questionnaire - Parent version at 20 completed sessions or at termination of intervention if terminated earlier. (time frame: After 20 completed sessions or immediately after termination of the intervention, if terminated earlier than 20 sessions). The study lists 4 primary outcomes in all. 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 12 Aug 2026.