NCT07040462

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

June 18, 2025

Last Update Submit

June 18, 2025

Conditions

Keywords

Child-Parent Psychotherapy (CPP)Trauma TherapyPreschool ChildrenKahramanmaraş Earthquake

Outcome Measures

Primary Outcomes (1)

  • 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).

    From baseline (Week 0) to 12 weeks post-intervention.

Secondary Outcomes (5)

  • Change in Child Social-Emotional Functioning

    From baseline (Week 0) to 12 weeks post-intervention.

  • Change in Child Attachment Security

    From baseline (Week 0) to 12 weeks post-intervention.

  • Change in Parental Reflective Functioning

    From baseline (Week 0) to 12 weeks post-intervention.

  • Change in Parenting Stress

    From baseline (Week 0) to 12 weeks post-intervention

  • Change in Caregiver Depression, Anxiety, and Stress

    From baseline (Week 0) to 12 weeks post-intervention.

Study Arms (2)

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.

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).

Interventions

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.

Child-Parent Psychotherapy (CPP)

Eligibility Criteria

Age3 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beykoz University

Istanbul, Istanbul, 34340, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Metin Çınaroğlu, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 27, 2025

Study Start

June 15, 2025

Primary Completion

October 15, 2025

Study Completion

November 15, 2025

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will be made available 6 months after publication of the study results and remain accessible for 5 years.
Access Criteria
Requests should be submitted to the principal investigator and will be evaluated based on the scientific validity and ethical compliance of the proposal.

Locations