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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06619821
Acronym
EASY-PEP
Enrollment
3000
Registered
2024-10-01
Start date
2024-09-27
Completion date
2025-07-31
Last updated
2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adverse Childhood Experiences, Stress, Emotional, Stress-related Mental Disorders

Keywords

adolescents, randomized controlled trial, PTSD, ACE, depression, anxiety

Brief summary

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.

Interventions

BEHAVIORALPCE 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.

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.

BEHAVIORALPsychoeducation

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.

Sponsors

Peking University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Alexithymiabaseline, post treatment(1 month), 3 month after post treatmentA 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 adolescentsbaseline, post treatment(1 month), 3 month after post treatmentThe 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.
Emotion awarenessbaseline, post treatment(1 month), 3 month after post treatmentA 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 regulationbaseline, post treatment(1 month), 3 month after post treatmentAn 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.
Depressionbaseline, post treatment(1 month), 3 month after post treatmentThe 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 disorderbaseline, post treatment(1 month), 3 month after post treatmentThe 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

MeasureTime frameDescription
Insomnia Severitybaseline, post treatment(1 month), 3 month after post treatmentThe 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.
Irritabilitybaseline, post treatment(1 month), 3 month after post treatmentA 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.
Resiliencebaseline, post treatment(1 month), 3 month after post treatmentA 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 .
Seeking for helpbaseline, post treatment(1 month), 3 month after post treatmentA 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.

Other

MeasureTime frameDescription
Subjective Units of Distress Scaleeach week during intervention (up to 4 months)A single item inquires about subjective distress on a 100-point scale. A higher score represents more subjective distress.
Positive Childhood Experiencesbaseline, post treatment(1 month), 3 month after post treatmentA questionnaire measuring positive childhood experiences with 13 items(total scores vary from 0 to 64). A higher score represents a more positive childhood experiences.
Game Addiction Scalebaseline, post treatment(1 month), 3 month after post treatmentA 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.
Behavior performancesbaseline, post treatment(1 month), 3 month after post treatmentA 22-item behavior performance questionnaire measures various behavior performances such as study time, phone use, school performance, drinking alcohol, smoking, stealing, fighting, and lying.
Adverse eventsbaseline, post treatment(1 month)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)
Meaning in lifebaseline, post treatment(1 month), 3 month after post treatmentA 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.
Non-suicidal self-injurybaseline, post treatment(1 month), 3 month after post treatmentThe 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.
Self-esteem stabilitybaseline, post treatment(1 month), 3 month after post treatmentA 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.
Somatic problemsbaseline, post treatment(1 month), 3 month after post treatmentA 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.
Problematic Internet usebaseline, post treatment(1 month), 3 month after post treatmentA 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.
Adverse Childhood Experiencesbaseline, post treatment(1 month), 3 month after post treatmentAn adverse childhood experiences questionnaire measuring the adverse childhood experiences with 26 items. A higher number of adverse childhood experiences represents worse childhood experiences.
Suicidebaseline, post treatment(1 month), 3 month after post treatmentThe 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.
Self-esteembaseline, post treatment(1 month), 3 month after post treatmentA 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.
Social supportbaseline, post treatment(1 month), 3 month after post treatmentThe 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.
Subjective Happiness Scalebaseline, post treatment(1 month), 3 month after post treatmentA 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026