跳至主要内容
临床试验/NCT07040462
NCT07040462招募中不适用

Child-Parent Psychotherapy for Post-Earthquake Trauma in Preschool Children: A Randomized Controlled Trial

Beykoz University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Change in Child Trauma Symptom Severity

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: Child-Parent Psychotherapy (CPP) (Behavioral)

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).

结局指标

主要结局

Change in Child Trauma Symptom Severity

时间窗: 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).

次要结局

  • 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.)

研究者

发起方
Beykoz University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eda Yilmazer

Dr

Beykoz University

研究点 (1)

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