Effects of Parent-Adolescent Joint Interventions for Adolescents With Adverse Childhood Experiences (EASY-PEP)

Effects of Parent-Adolescent Joint Interventions for Adolescents With Adverse Childhood Experiences: A Multi-Center Cluster Randomized Controlled Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress, Emotional; Adverse Childhood Experiences; Stress-related Mental Disorders
• Intervention / Treatment: Behavioral: Psychoeducation; Behavioral: Emotiaonl skill enhancement; Behavioral: PCE promotion

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hebei
    • Baoding, Hebei, China
      • Diannan middle school
    • Baoding, Hebei, China
      • Biancun middle school

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Psychoeducation group （PsyE）; Psychoeducation consists of parent and adolescent psychoeducation. The content includes an introduction to stress, emotional distress and mental disorders.	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.
Experimental: 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.	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.; Behavioral: 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.; 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.
Experimental: 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.	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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alexithymia	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.	baseline, post treatment(1 month), 3 month after post treatment
PTSD for adolescents	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.	baseline, post treatment(1 month), 3 month after post treatment
Emotion awareness	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.	baseline, post treatment(1 month), 3 month after post treatment
Emotion regulation	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.	baseline, post treatment(1 month), 3 month after post treatment
Depression	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.	baseline, post treatment(1 month), 3 month after post treatment
Generalized anxiety disorder	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.	baseline, post treatment(1 month), 3 month after post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Irritability	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.	baseline, post treatment(1 month), 3 month after post treatment
Resilience	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 .	baseline, post treatment(1 month), 3 month after post treatment
Seeking for help	A 10-item help-seeking scale measures on a 7-point Likert scale (score from 1 to 7, and total score varies from 10 to 70), with higher scores indicating greater willingness to seek help from others.	baseline, post treatment(1 month), 3 month after post treatment
Insomnia Severity	The severity of insomnia symptoms will be assessed using the Insomnia Severity Index (ISI). This 7-item self-report measurement evaluates the severity of insomnia symptoms, the level of satisfaction with sleep, interference with daily functioning, noticeability of impairment attributed to sleep problems, and the level of distress caused by sleep disturbance (score from 0 to 4, and total score vary from 0 to 32). Each item is rated on a 5-point scale, providing a comprehensive measure of insomnia severity.	baseline, post treatment(1 month), 3 month after post treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-esteem	A 10-item self-esteemmeasurement scale, Rosenberg self-esteem scale, measures self-esteem on a 4-point Likert scale (score from 0 to 3, and total score varies from 0 to 30), with higher scores indicating greater self-esteem.	baseline, post treatment(1 month), 3 month after post treatment
Subjective Happiness Scale	A 4-item subjective happiness scale measures happiness (score from 1 to 7, and total score vary from 4 to 28). A higher score represents a happier state.	baseline, post treatment(1 month), 3 month after post treatment
Game Addiction Scale	A 7-item game addiction scale, measures game addiction on a 5-point Likert scale (score from 1 to 5, and total score varies from 7 to 35), with higher scores indicating worse game addiction.	baseline, post treatment(1 month), 3 month after post treatment
Meaning in life	A 6-item meaning in life scale measures life meaning (score from 1 to 5, and total score vary from 6 to 30). A higher score represents more life meaning perception.	baseline, post treatment(1 month), 3 month after post treatment
Subjective Units of Distress Scale	A single item inquires about subjective distress on a 100-point scale. A higher score represents more subjective distress.	each week during intervention (up to 4 months)
Suicide	The suicidal behaviors questionnaire-revised (SBQ-R) for adolescents and children (total scores vary from 3 to 18). A higher score represents a higher suicide risk.	baseline, post treatment(1 month), 3 month after post treatment
Social support	The 12-item Multidimensional Scale of Perceived Social Support (score from 1 to 7, and total score varies from 12 to 84). A higher score represents better social support.	baseline, post treatment(1 month), 3 month after post treatment
Positive Childhood Experiences	A questionnaire measuring positive childhood experiences with 13 items(total scores vary from 0 to 64). A higher score represents a more positive childhood experiences.	baseline, post treatment(1 month), 3 month after post treatment
Behavior performances	A 22-item behavior performance questionnaire measures various behavior performances such as study time, phone use, school performance, drinking alcohol, smoking, stealing, fighting, and lying.	baseline, post treatment(1 month), 3 month after post treatment
Non-suicidal self-injury	The non-suicidal self-injury assessment tool (NSSI-AT-Severity) for adolescents and children (total scores vary from 5 to 16). A higher score represents a worse self-injury situation.	baseline, post treatment(1 month), 3 month after post treatment
Self-esteem stability	A 5-item Labile Self-Esteem Scale measures self-esteem stability on a 5-point Likert scale (score from 1 to 5, and total score varies from 5 to 25), with lower scores indicating better self-esteem stability.	baseline, post treatment(1 month), 3 month after post treatment
Somatic problems	A somatic problems scale modified from PHQ-15, measuring various physical discomforts and pain on a 3-point Likert scale (score from 0 to 2). A higher score represents worse somatic problems.	baseline, post treatment(1 month), 3 month after post treatment
Problematic Internet use	A 10-item problematic Internet use scale measures problematic Internet use on a 7-point Likert scale (score from 1 to 7, and total score varies from 7 to 49), with higher scores indicating greater problematic Internet use.	baseline, post treatment(1 month), 3 month after post treatment
Adverse Childhood Experiences	An adverse childhood experiences questionnaire measuring the adverse childhood experiences with 26 items. A higher number of adverse childhood experiences represents worse childhood experiences.	baseline, post treatment(1 month), 3 month after post treatment
Adverse events	A 33-item adverse events questionnaire asks about adverse events before 18, including self-harm, experiencing emotional abuse, experiencing physical abuse, feeling severe distress, mental illness events (e.g., panic attack), and physical injury, etc. The score of each item ranges from 0 to 1(0=no, 1=yes), 0 to 4, or 0 to 5 (a higher score indicates a more severe adverse event)	baseline, post treatment(1 month)

Collaborators and Investigators

• Sponsor: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2024
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 28, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 29, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: PTSD; randomized controlled trial; depression; anxiety; adolescents; ACE
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Stress, Psychological
• Other Study ID Numbers: Joint Tx for Adolscents ACEs

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No