Stress, EmotionalEASY-PEPNCT06619821
Effects of Parent-Adolescent Joint Interventions for Adolescents With Adverse Childhood Experiences
A study testing Emotiaonl skill enhancement, PCE promotion and Psychoeducation in people with Stress, Emotional and Stress-related Mental Disorders, run by Peking University at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Emotional, Stress-related Mental Disorders, Adverse Childhood Experiences
- What is being tested?
- Emotiaonl skill enhancement, PCE promotion and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 2 sitesChina
- Study dates
- 27 Sep 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Middle school students studying in school and their parents
- Capable of hearing, speaking, reading, and writing
Who cannot join
- High suicidal risks
- Severe mental disorders
Trial locations and contacts
2 sites in 1 country.
China2 sites
Biancun middle school
Baoding, Hebei
Diannan middle school
Baoding, Hebei
About this study
Official title: 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.
- Being tested
- Emotiaonl skill enhancement, PCE promotion, Psychoeducation
- Keywords
- adolescents, randomized controlled trial, PTSD, ACE, depression, anxiety
- Medical subject headings
- Stress, Psychological, Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotiaonl skill enhancementBehavioural
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 promotionBehavioural
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.
PsychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychoeducation group （PsyE） | Active comparator | Psychoeducation consists of parent and adolescent psychoeducation. The content includes an introduction to stress, emotional distress and mental disorders. Receives: Behavioral: Psychoeducation |
| Psychoeducation + Emotional Skills (PsyE+EmoS) | Experimental | 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. Receives: Behavioral: Emotiaonl skill enhancement; Behavioral: PCE promotion; Behavioral: Psychoeducation |
| Psychoeducation + emotional skills + PCE (PsyE+EmoS+PoCE) | Experimental | 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. Receives: Behavioral: Emotiaonl skill enhancement; Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline, post treatment(1 month), 3 month after post treatment
Secondary outcomes (4)
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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: baseline, post treatment(1 month), 3 month after post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start27 Sep 2024
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, EmotionalStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinyin Zang, PhD, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619821
- Sponsor's protocol ID
- Joint Tx for Adolscents ACEs
- Acronym
- EASY-PEP
- Status last verified
- Nov 2024
- First submitted
- 19 Sep 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parent-Adolescent Joint Interventions for Adolescents With Adverse Childhood Experiences: A Multi-Center Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06619821
- Acronym / sponsor ID
- EASY-PEP / Joint Tx for Adolscents ACEs
- Keywords
- adolescents, randomized controlled trial, PTSD, ACE, depression, anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation group （PsyE） | Active comparator | Behavioral: PsychoeducationPsychoeducation consists of parent and adolescent psychoeducation. The content includes an introduction to stress, emotional distress and mental disorders. |
| Psychoeducation + Emotional Skills (PsyE+EmoS) | Experimental | Behavioral: Emotiaonl skill enhancement, Behavioral: PCE promotion, Behavioral: PsychoeducationPsychoeducation 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. |
| Psychoeducation + emotional skills + PCE (PsyE+EmoS+PoCE) | Experimental | Behavioral: Emotiaonl skill enhancement, Behavioral: PsychoeducationIn 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Middle school students studying in school and their parents
- Capable of hearing, speaking, reading, and writing
Key exclusion criteria (2 listed)
- High suicidal risks
- Severe mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotiaonl skill enhancementThis 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. | Behavioural | Psychoeducation + Emotional Skills (PsyE+EmoS), Psychoeducation + emotional skills + PCE (PsyE+EmoS+PoCE) |
| PCE promotionThe 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. | Behavioural | Psychoeducation + Emotional Skills (PsyE+EmoS) |
| PsychoeducationPsychoeducation 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. | Behavioural | Psychoeducation + Emotional Skills (PsyE+EmoS), Psychoeducation + emotional skills + PCE (PsyE+EmoS+PoCE), Psychoeducation group （PsyE） |
Primary outcome
Alexithymia
Time frame: baseline, post treatment(1 month), 3 month after post treatment
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.
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.
4 secondary outcomes
Irritability
Time frame: baseline, post treatment(1 month), 3 month after post treatment
Resilience
Time frame: baseline, post treatment(1 month), 3 month after post treatment
Seeking for help
Time frame: baseline, post treatment(1 month), 3 month after post treatment
Insomnia Severity
Time frame: baseline, post treatment(1 month), 3 month after post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotiaonl skill enhancement, PCE promotion and Psychoeducation in people with Stress, Emotional and Stress-related Mental Disorders, run by Peking University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alexithymia (time frame: baseline, post treatment(1 month), 3 month after post treatment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.