Post-Traumatic Stress Disorder ComplexNCT07040462
Child-Parent Psychotherapy After the 2023 Kahramanmaraş Earthquake
A study testing Child-Parent Psychotherapy (CPP) in people with Post-Traumatic Stress Disorder Complex and Emotional Dysregulation, run by Beykoz University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effectiveness of Child-Parent Psychotherapy (CPP) in reducing trauma-related symptoms and improving attachment quality among preschool-aged children who experienced the 2023 Kahramanmaraş earthquakes in Türkiye. Read more about this study
- Who is it for?
- Ages 3 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder Complex, Emotional Dysregulation
- What is being tested?
- Child-Parent Psychotherapy (CPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 15 Nov 2025
- Phase
- Interventional
- 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 3 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children aged 3 to 6 years old at the time of enrollment
- Resided in one of the 11 cities affected by the 2023 Kahramanmaraş earthquake (e.g., Hatay, Kahramanmaraş, Adıyaman, Malatya, Gaziantep, Şanlıurfa, Adana, Osmaniye, Diyarbakır, Kilis, Elazığ)
- Exposure to at least one qualifying traumatic event due to the earthquake (e.g., witnessing injury or death, loss of home, separation from caregiver)
- Living with a primary caregiver (mother or father) who consents to participate in the study
- Both caregiver and child are available to participate in 12 weekly sessions of CPP (online or face-to-face)
- Caregiver is fluent in Turkish and able to complete self-report questionnaires
Who cannot join
- Child or caregiver currently receiving psychotherapy or psychiatric treatment
- Child diagnosed with developmental disorder (e.g., autism, intellectual disability) that significantly impairs communication or relational functioning
- Caregiver with a diagnosed severe psychiatric disorder (e.g., psychosis, bipolar disorder) or active substance use disorder
- Families with ongoing legal custody disputes or instability that may interfere with consistent participation
- Inability to access internet or digital device (for participants randomized to online therapy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Beykoz University
Istanbul, Istanbul, 34340
Eda Yılmazer, Phd, +905322575880, edayilmazer@beykoz.edu.tr
Metin Çınaroğlu, Phd, 09053247320, metincinaroglu@gmail.com
About this study
Official title: Child-Parent Psychotherapy for Post-Earthquake Trauma in Preschool Children: A Randomized Controlled Trial
This study aims to evaluate the effectiveness of Child-Parent Psychotherapy (CPP) in reducing trauma-related symptoms and improving attachment quality among preschool-aged children who experienced the 2023 Kahramanmaraş earthquakes in Türkiye. A total of 60 caregiver-child dyads (children aged 3-6) will be recruited from 11 earthquake-affected provinces. Participants will be randomly assigned to either the intervention group, receiving 12 weekly CPP sessions, or a no-intervention control group. CPP will be delivered by trained clinical psychologists through either online or face-to-face sessions. Assessments will be conducted at baseline, mid-intervention (after session 6), and post-intervention (after session 12). Outcomes include child trauma symptoms, social-emotional functioning, and attachment quality, as well as caregiver reflective functioning, stress, and emotional well-being.
Read the detailed description
This randomized controlled trial investigates the impact of Child-Parent Psychotherapy (CPP) on post-traumatic recovery and attachment in children aged 3 to 6 years who were exposed to the 2023 Kahramanmaraş earthquakes. CPP is a trauma-informed dyadic therapy that integrates psychodynamic, cognitive-behavioral, attachment, and developmental principles, emphasizing co-construction of trauma narratives and caregiver reflective functioning through play-based interaction.
The study will enroll 60 caregiver-child dyads from the 11 most affected cities in Türkiye: Kahramanmaraş, Hatay, Adıyaman, Gaziantep, Malatya, Adana, Osmaniye, Diyarbakır, Şanlıurfa, Kilis, and Elazığ. Eligible participants include children who were between 1-4 years old at the time of the disaster and are currently aged 3-6, along with a primary caregiver (mother or father) who is consistently involved in daily care.
The intervention group will receive 12 weekly CPP sessions (60 minutes each), conducted either online or in person, depending on logistical and contextual needs. Sessions will be delivered by licensed clinical psychologists trained in the CPP protocol. The control group will receive no intervention during the trial period but will complete assessments in parallel with the intervention group.
Primary outcomes include reduction in child trauma symptoms and improvement in social-emotional functioning and attachment quality. Secondary outcomes include parental stress, reflective functioning, and symptoms of depression, anxiety, and stress. Data will be collected at three timepoints: baseline (T1), mid-intervention (after session 6, T2), and post-intervention (after session 12, T3).
All instruments are validated in Turkish populations and age-appropriate. The child measures include the Ages \& Stages Questionnaires: Social-Emotional (ASQ:SE), Brief Attachment Scale (BAS-16), and a trauma symptom checklist appropriate for preschoolers. Caregiver measures include the Parental Reflective Functioning Questionnaire (PRFQ), Parenting Stress Index Short Form (PSI-SF), and the Depression Anxiety Stress Scale (DASS-21).
- Being tested
- Child-Parent Psychotherapy (CPP)
- Keywords
- Child-Parent Psychotherapy (CPP), Trauma Therapy, Preschool Children, Kahramanmaraş Earthquake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Child-Parent Psychotherapy (CPP)Behavioural
CPP is a structured, evidence-based dyadic therapy designed for children aged 0-6 exposed to trauma and their caregivers. The intervention involves weekly joint sessions emphasizing safety, emotional expression, and caregiver reflective functioning. Delivered by trained psychologists either online or in person.
| Study group | Role | What they receive |
|---|---|---|
| Child-Parent Psychotherapy (CPP) | Experimental | Participants in this arm will receive 12 weekly Child-Parent Psychotherapy (CPP) sessions, each lasting approximately 60 minutes. CPP is a trauma-informed, attachment-based intervention that integrates psychodynamic, cognitive-behavioral, and developmental principles. Sessions are dyadic (child and caregiver together) and may be conducted face-to-face or online. Therapists are trained clinical psychologists. The intervention focuses on emotional regulation, trauma narrative development, and strengthening the caregiver-child bond. Receives: Behavioral: Child-Parent Psychotherapy (CPP) |
| No-Treatment Control | No intervention | Participants in this arm will receive no psychological intervention during the 12-week study period. They will, however, complete outcome assessments at the same three timepoints as the intervention group (baseline, mid-intervention, and post-intervention). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Child Trauma Symptom Severity
Child trauma symptoms will be assessed using the Child PTSD Reaction Index (CPTSD-RI), a 20-item caregiver-report scale developed to evaluate post-traumatic stress reactions in children following exposure to traumatic events. Items are rated on a 5-point Likert scale ranging from 0 (none) to 4 (most of the time), yielding a total score ranging from 0 to 80. Higher scores reflect greater severity of PTSD symptoms, with cutoffs indicating doubtful (0-11), mild (12-24), moderate (25-39), severe (40-59), and very severe (60-80) symptom levels. The measure will be administered at three time points: baseline (Week 0), mid-treatment (Week 6), and post-treatment (Week 12).
Measured: From baseline (Week 0) to 12 weeks post-intervention.
Secondary outcomes (5)
Change in Child Social-Emotional Functioning
Assessed using the ASQ:SE, a caregiver-report scale evaluating emotion regulation, social interaction, and adaptive functioning. Total scores vary by age version, typically up to ~310. Higher scores indicate more social-emotional difficulties.
Measured: From baseline (Week 0) to 12 weeks post-intervention.
Change in Child Attachment Security
Measured using the BAS-16, a 16-item scale assessing attachment security and proximity-seeking. Scores range from 16 to 80, with higher scores indicating more secure attachment.
Measured: From baseline (Week 0) to 12 weeks post-intervention.
Change in Parental Reflective Functioning
Evaluated using the PRFQ, an 18-item caregiver-report measure of mentalization. Scores range from 18 to 126, with interpretation based on subscale balance.
Measured: From baseline (Week 0) to 12 weeks post-intervention.
Change in Parenting Stress
Measured by the PSI-SF, a 36-item scale with scores ranging from 36 to 180, where higher scores indicate greater stress.
Measured: From baseline (Week 0) to 12 weeks post-intervention
Change in Caregiver Depression, Anxiety, and Stress
Assessed by the DASS-21, which yields three subscale scores (each 0-42) for depression, anxiety, and stress. Higher scores indicate greater emotional distress.
Measured: From baseline (Week 0) to 12 weeks post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start15 Jun 2025
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder ComplexStudies 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
- Participants will be randomly assigned to one of two parallel arms: (1) Child-Parent Psychotherapy (CPP) or (2) No-treatment control. Each participant remains in their assigned arm throughout the 12-week study.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beykoz University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Nisantasi University
- Responsible party
- Principal investigator, Eda Yilmazer, Beykoz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07040462
- Sponsor's protocol ID
- CPP-Kahramanmaras-RCT-2025
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in this study (after de-identification) will be made available to researchers who provide a methodologically sound proposal. Data will include participant-level data for primary and secondary outcomes. Supporting documents such as the study protocol, statistical analysis plan, and informed consent form will also be made available upon request. Data will be available beginning 6 months after publication of the main findings and will remain accessible for 3 years via a secure institutional repository or upon request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Child-Parent Psychotherapy for Post-Earthquake Trauma in Preschool Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07040462
- Acronym / sponsor ID
- CPP-Kahramanmaras-RCT-2025
- Keywords
- Child-Parent Psychotherapy (CPP), Trauma Therapy, Preschool Children, Kahramanmaraş Earthquake
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beykoz UniversityUniversity, hospital or other
- Collaborators
- Istanbul Nisantasi University
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 27 Jun 2025 (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.
This study aims to evaluate the effectiveness of Child-Parent Psychotherapy (CPP) in reducing trauma-related symptoms and improving attachment quality among preschool-aged children who experienced the 2023 Kahramanmaraş earthquakes in Türkiye. A total of 60 caregiver-child dyads (children aged 3-6) will be recruited from 11 earthquake-affected provinces. Participants will be randomly assigned to either the intervention group, receiving 12 weekly CPP sessions, or a no-intervention control group. CPP will be delivered by trained clinical psychologists through either online or face-to-face sessions. Assessments will be conducted at baseline, mid-intervention (after session 6), and post-intervention (after session 12). Outcomes include child trauma symptoms, social-emotional functioning, and attachment quality, as well as caregiver reflective functioning, stress, and emotional well-being.
Detailed description
This randomized controlled trial investigates the impact of Child-Parent Psychotherapy (CPP) on post-traumatic recovery and attachment in children aged 3 to 6 years who were exposed to the 2023 Kahramanmaraş earthquakes. CPP is a trauma-informed dyadic therapy that integrates psychodynamic, cognitive-behavioral, attachment, and developmental principles, emphasizing co-construction of trauma narratives and caregiver reflective functioning through play-based interaction.
The study will enroll 60 caregiver-child dyads from the 11 most affected cities in Türkiye: Kahramanmaraş, Hatay, Adıyaman, Gaziantep, Malatya, Adana, Osmaniye, Diyarbakır, Şanlıurfa, Kilis, and Elazığ. Eligible participants include children who were between 1-4 years old at the time of the disaster and are currently aged 3-6, along with a primary caregiver (mother or father) who is consistently involved in daily care.
The intervention group will receive 12 weekly CPP sessions (60 minutes each), conducted either online or in person, depending on logistical and contextual needs. Sessions will be delivered by licensed clinical psychologists trained in the CPP protocol. The control group will receive no intervention during the trial period but will complete assessments in parallel with the intervention group.
Primary outcomes include reduction in child trauma symptoms and improvement in social-emotional functioning and attachment quality. Secondary outcomes include parental stress, reflective functioning, and symptoms of depression, anxiety, and stress. Data will be collected at three timepoints: baseline (T1), mid-intervention (after session 6, T2), and post-intervention (after session 12, T3).
All instruments are validated in Turkish populations and age-appropriate. The child measures include the Ages \& Stages Questionnaires: Social-Emotional (ASQ:SE), Brief Attachment Scale (BAS-16), and a trauma symptom checklist appropriate for preschoolers. Caregiver measures include the Parental Reflective Functioning Questionnaire (PRFQ), Parenting Stress Index Short Form (PSI-SF), and the Depression Anxiety Stress Scale (DASS-21).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel arms: (1) Child-Parent Psychotherapy (CPP) or (2) No-treatment control. Each participant remains in their assigned arm throughout the 12-week study.
| Arm | Type | Receives |
|---|---|---|
| Child-Parent Psychotherapy (CPP) | Experimental | Behavioral: Child-Parent Psychotherapy (CPP)Participants in this arm will receive 12 weekly Child-Parent Psychotherapy (CPP) sessions, each lasting approximately 60 minutes. CPP is a trauma-informed, attachment-based intervention that integrates psychodynamic, cognitive-behavioral, and developmental principles. Sessions are dyadic (child and caregiver together) and may be conducted face-to-face or online. Therapists are trained clinical psychologists. The intervention focuses on emotional regulation, trauma narrative development, and strengthening the caregiver-child bond. |
| No-Treatment Control | No intervention | –Participants in this arm will receive no psychological intervention during the 12-week study period. They will, however, complete outcome assessments at the same three timepoints as the intervention group (baseline, mid-intervention, and post-intervention). |
Who may qualify
- Ages
- 3 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Children aged 3 to 6 years old at the time of enrollment
- Resided in one of the 11 cities affected by the 2023 Kahramanmaraş earthquake (e.g., Hatay, Kahramanmaraş, Adıyaman, Malatya, Gaziantep, Şanlıurfa, Adana, Osmaniye, Diyarbakır, Kilis, Elazığ)
- Exposure to at least one qualifying traumatic event due to the earthquake (e.g., witnessing injury or death, loss of home, separation from caregiver)
- Living with a primary caregiver (mother or father) who consents to participate in the study
- Both caregiver and child are available to participate in 12 weekly sessions of CPP (online or face-to-face)
Key exclusion criteria (5 listed)
- Child or caregiver currently receiving psychotherapy or psychiatric treatment
- Child diagnosed with developmental disorder (e.g., autism, intellectual disability) that significantly impairs communication or relational functioning
- Caregiver with a diagnosed severe psychiatric disorder (e.g., psychosis, bipolar disorder) or active substance use disorder
- Families with ongoing legal custody disputes or instability that may interfere with consistent participation
- Inability to access internet or digital device (for participants randomized to online therapy)
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 Psychotherapy (CPP)CPP is a structured, evidence-based dyadic therapy designed for children aged 0-6 exposed to trauma and their caregivers. The intervention involves weekly joint sessions emphasizing safety, emotional expression, and caregiver reflective functioning. Delivered by trained psychologists either online or in person. | Behavioural | Child-Parent Psychotherapy (CPP) |
Primary outcome
Change in Child Trauma Symptom Severity
Time frame: From baseline (Week 0) to 12 weeks post-intervention.
Child trauma symptoms will be assessed using the Child PTSD Reaction Index (CPTSD-RI), a 20-item caregiver-report scale developed to evaluate post-traumatic stress reactions in children following exposure to traumatic events. Items are rated on a 5-point Likert scale ranging from 0 (none) to 4 (most of the time), yielding a total score ranging from 0 to 80. Higher scores reflect greater severity of PTSD symptoms, with cutoffs indicating doubtful (0-11), mild (12-24), moderate (25-39), severe (40-59), and very severe (60-80) symptom levels. The measure will be administered at three time points: baseline (Week 0), mid-treatment (Week 6), and post-treatment (Week 12).
5 secondary outcomes
Change in Child Social-Emotional Functioning
Time frame: From baseline (Week 0) to 12 weeks post-intervention.
Change in Child Attachment Security
Time frame: From baseline (Week 0) to 12 weeks post-intervention.
Change in Parental Reflective Functioning
Time frame: From baseline (Week 0) to 12 weeks post-intervention.
Change in Parenting Stress
Time frame: From baseline (Week 0) to 12 weeks post-intervention
Change in Caregiver Depression, Anxiety, and Stress
Time frame: From baseline (Week 0) to 12 weeks post-intervention.
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 27 Jun 2025.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in this study (after de-identification) will be made available to researchers who provide a methodologically sound proposal. Data will include participant-level data for primary and secondary outcomes. Supporting documents such as the study protocol, statistical analysis plan, and informed consent form will also be made available upon request. Data will be available beginning 6 months after publication of the main findings and will remain accessible for 3 years via a secure institutional repository or upon request to the principal investigator.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Child-Parent Psychotherapy (CPP) in people with Post-Traumatic Stress Disorder Complex and Emotional Dysregulation, run by Beykoz University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 27 Jun 2025. 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 Turkey (Türkiye). 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?
Contact Eda Yılmazer, Phd (+905322575880, edayilmazer@beykoz.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Child Trauma Symptom Severity (time frame: From baseline (Week 0) to 12 weeks post-intervention.). 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 27 Jun 2025.