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Active, Not Recruiting

NCT Number: NCT06650696

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diannan middle school

Baoding, Hebei, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCE promotion

Behavioral

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

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.

Emotiaonl skill enhancement

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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 .

  5. 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.

  6. 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.

  7. 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.

  8. 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

  1. Self-esteem

    Time frame: baseline, post treatment(1 month), 3 month after post treatment

    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.

  2. Subjective Happiness Scale

    Time frame: baseline, post treatment(1 month), 3 month after post treatment

    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.

  3. Seeking for help

    Time frame: baseline, post treatment(1 month), 3 month after post treatment

    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.

  4. Insomnia Severity

    Time frame: baseline, post treatment(1 month), 3 month after post treatment

    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.

Other outcomes

  1. Suicide

    Time frame: baseline, post treatment(1 month), 3 month after post treatment

    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.

  2. Social support

    Time frame: baseline, post treatment(1 month), 3 month after post treatment

    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.

  3. Positive Childhood Experiences

    Time frame: baseline, post treatment(1 month), 3 month after post treatment

    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.

  4. Behavior performances

    Time frame: baseline, post treatment(1 month), 3 month after post treatment

    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.

  5. Adverse events

    Time frame: baseline, post treatment(1 month)

    A 6-item questionnaire asks about adverse events since last month, including self-harm, experiencing emotional abuse, experiencing physical abuse, feeling severe distress, mental illness events (e.g., panic attack), and physical injury.

  6. Non-suicidal self-injury

    Time frame: baseline, post treatment(1 month), 3 month after post treatment

    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.

  7. Game Addiction Scale

    Time frame: baseline, post treatment(1 month), 3 month after post treatment

    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.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Acronym: EASY-PEP-i

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2024
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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