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Active, not recruiting Not applicable

Effects of Parent-Adolescent Joint I-Interventions for Adolescents with Adverse Childhood Experiences

NCT06650696 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2024-09-27
Last updated
2024-12-02

Condition(s) studied

Stress-related ProblemStress, Emotional

Investigational drug(s) / intervention(s)

PCE promotionPsychoeducationEmotiaonl skill enhancement

PCE promotion: The intervention requires parents to complete a weekly parent-child interaction task online designed to foster positive childhood experiences. Parents will engage in structured activities with their children and document the interactions. Each week, they are expected to upload a report.

Psychoeducation: Psychoeducation includes sessions for both parents and adolescents, covering key topics such as stress, emotional distress, and mental disorders. The content provides foundational knowledge to help participants understand and manage these challenges.

Emotiaonl skill enhancement: This intervention combines online material with practical, emotion-focused activities. Participants will receive training online on emotional awareness and emotion regulation strategies, along with completing weekly writing assignments. These assignments focus on recent negative events and the emotions associated with them, encouraging emotional expression and processing.

Study summary

The study aims to examine the effectiveness of internet-based Parent-Adolescent Joint Interventions in improving the mental health outcomes of participants, specifically by reducing symptoms of depression, anxiety, and PTSD, as measured by the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder-7 scale (GAD-7), and the Child PTSD Symptom Scale for DSM-5 (CPSS-5). Adolescents will be recruited from middle schools and randomly assigned to one of three groups: (a) psychoeducation, (b) psychoeducation + emotional skills enhancement, or (c) psychoeducation + emotional skills enhancement + positive childhood experience promotion. The school-based intervention will consist of 4-8 sessions, with assessments conducted at baseline, post-treatment, and a 3-month follow-up. Investigators will conduct multilevel models (MLMs) and structural equation models (SEMs) to investigate the impact of Adverse Childhood Experiences (ACEs), Positive Childhood Experiences (PCEs), alexithymia, and emotion regulation abilities on mental health outcomes in adolescents.

Eligibility

Sex
ALL
Min age
10 Years
Max age
18 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Middle school students studying in school and their parents * Capable of hearing, speaking, reading, and writing Exclusion Criteria: * High suicidal risks * Severe mental disorders

Primary outcome measure(s)

  • Alexithymia — baseline, post treatment(1 month), 3 month follow-up
    A 36-item Peking alexithymia scale measures thoughts and behaviors that prevent people from feeling or recognizing negative emotions on a 5-point Likert scale (1 to 5, and total scores vary from 36 to 180). A higher score represents more severe alexithymia.
  • Irritability — baseline, post treatment(1 month), 3 month after post treatment
    A 17-item irritability measurement scale, the Peking irritability scale, measures impulsive emotions, thoughts, and behaviors on a 5-point Likert scale (score from 1 to 5, and total score varies from 17 to 85). A higher score represents higher irritability.
  • PTSD for adolescents — baseline, post treatment(1 month), 3 month after post treatment
    The Child PTSD Symptom Scale for DSM-5 (CPSS-5) for adolescents and children (scores from 0 to 4, and total scores vary from 0 to 80). A higher score represents worse PTSD symptoms.
  • Resilience — baseline, post treatment(1 month), 3 month after post treatment
    A 10-item resilience measurement scale, the Connor-Davidson resilience scale, measures resilience on a 5-point Likert scale (score from 0 to 4, and total score varies from 0 to 40). A higher score represents better resilience .
  • Emotion awareness — baseline, post treatment(1 month), 3 month after post treatment
    A 30-item Emotion awareness questionnaire measures emotion awareness on a 3-point Likert scale (1 to 3, and total scores vary from 30 to 90). A higher score represents better emotion awareness.
  • Emotion regulation — baseline, post treatment(1 month), 3 month after post treatment
    An 18-item cognitive emotion regulation questionnaire measures the ability of emotion regulation on a 5-point Likert scale (1 to 5, and total scores vary from 18 to 90). A higher score represents better emotion regulation.
  • Depression — baseline, post treatment(1 month), 3 month after post treatment
    The 9-item patient health questionnaire (PHQ-9) for adults (score from 0 to 3, and total score varies from 0 to 27). A higher score represents worse depression symptoms.
  • Generalized anxiety disorder — baseline, post treatment(1 month), 3 month after post treatment
    The Generalized Anxiety Disorder-7 scale (GAD-7) for adults, adolescents, and children (scored from 0 to 3, and total score from 0 to 21). A higher score represents worse anxiety symptoms.

Trial sites (1)

FacilityCityRegionStatus
Diannan middle school Baoding Hebei
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06650696 on ClinicalTrials.gov ↗ ← All trials in China