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Clinical Trials/NCT06650696
NCT06650696
Active, Not Recruiting
N/A

Effects of Parent-Adolescent Joint Internet Interventions for Adolescents with Adverse Childhood Experiences: a Cluster Randomized Controlled Trial

Peking University1 site in 1 country200 target enrollmentSeptember 27, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stress-related Problem
Sponsor
Peking University
Enrollment
200
Locations
1
Primary Endpoint
Irritability
Status
Active, Not Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
September 27, 2024
End Date
December 31, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Peking University
Responsible Party
Principal Investigator
Principal Investigator

Yinyin Zang, PhD

Ph.D

Peking University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Irritability

Time Frame: 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.

Alexithymia

Time Frame: 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.

PTSD for adolescents

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • Self-esteem(baseline, post treatment(1 month), 3 month after post treatment)
  • Subjective Happiness Scale(baseline, post treatment(1 month), 3 month after post treatment)
  • Seeking for help(baseline, post treatment(1 month), 3 month after post treatment)
  • Insomnia Severity(baseline, post treatment(1 month), 3 month after post treatment)

Study Sites (1)

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