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

NCT ID: NCT06619821

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-27

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study aims to examine the effectiveness of joint parent-adolescent intervention 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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stress, Emotional Stress-related Mental Disorders Adverse Childhood Experiences

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Psychoeducation group (PsyE)

Psychoeducation consists of parent and adolescent psychoeducation. The content includes an introduction to stress, emotional distress and mental disorders.

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

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.

Psychoeducation + Emotional Skills (PsyE+EmoS)

Psychoeducation includes sessions for both parents and adolescents, offering the same content as the control group, which introduces stress, emotional distress, and mental disorders.

In addition, the emotional skills enhancement sessions provide online materials focused on emotional awareness and emotion regulation strategies, along with tasks related to the content. Participants will also be required to complete a weekly writing assignment, upload their written contents, and assess their level of subjective discomfort following each writing exercise.

Group Type EXPERIMENTAL

Emotiaonl skill enhancement

Intervention Type BEHAVIORAL

This intervention combines online material with practical, emotion-focused activities. Participants will receive training 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.

PCE promotion

Intervention Type BEHAVIORAL

The intervention requires parents to complete a weekly parent-child interaction task 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

Intervention Type BEHAVIORAL

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.

Psychoeducation + emotional skills + PCE (PsyE+EmoS+PoCE)

In comparison to the PsyE+EmoS group, this group additionally requires parents to complete a weekly parent-child communication task aimed at fostering positive childhood experiences. Parents are also expected to document and upload the details of these tasks each week.

Group Type EXPERIMENTAL

Emotiaonl skill enhancement

Intervention Type BEHAVIORAL

This intervention combines online material with practical, emotion-focused activities. Participants will receive training 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.

Psychoeducation

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Emotiaonl skill enhancement

This intervention combines online material with practical, emotion-focused activities. Participants will receive training 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.

Intervention Type BEHAVIORAL

PCE promotion

The intervention requires parents to complete a weekly parent-child interaction task 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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yinyin Zang, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Biancun middle school

Baoding, Hebei, China

Site Status

Diannan middle school

Baoding, Hebei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Joint Tx for Adolscents ACEs

Identifier Type: -

Identifier Source: org_study_id