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

NCT06650696 | Active Not Recruiting

• 1 other identifier: Joint i-Tx for Adolscents ACEs
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress-related Problem; Stress, Emotional

Keywords

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

Outcome Measures

Primary Outcomes (8)

• 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 follow-up

• 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

• 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

• 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

• 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 Outcomes (4)

• Self-esteem

  baseline, post treatment(1 month), 3 month after post treatment

• Subjective Happiness Scale

  baseline, post treatment(1 month), 3 month after post treatment

• Seeking for help

  baseline, post treatment(1 month), 3 month after post treatment

• Insomnia Severity

  baseline, post treatment(1 month), 3 month after post treatment

Other Outcomes (7)

• Suicide

  baseline, post treatment(1 month), 3 month after post treatment

• Social support

  baseline, post treatment(1 month), 3 month after post treatment

• Positive Childhood Experiences

  baseline, post treatment(1 month), 3 month after post treatment

Study Arms (3)

Psychoeducation group （PsyE）

ACTIVE COMPARATOR

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

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 via online programe. 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; Behavioral: Emotiaonl skill enhancement

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 via online programe aimed at fostering positive childhood experiences. Parents are also expected to document and upload the details of these tasks each week.

Behavioral: PCE promotion; Behavioral: Psychoeducation; Behavioral: Emotiaonl skill enhancement

Interventions

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

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.

Psychoeducation + Emotional Skills (PsyE+EmoS); Psychoeducation + emotional skills + PCE (PsyE+EmoS+PoCE); Psychoeducation group （PsyE）

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.

Psychoeducation + Emotional Skills (PsyE+EmoS); Psychoeducation + emotional skills + PCE (PsyE+EmoS+PoCE)

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Middle school students studying in school and their parents
• Capable of hearing, speaking, reading, and writing

You may not qualify if:

• High suicidal risks
• Severe mental disorders

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Diannan middle school

Baoding, Hebei, China

Location

MeSH Terms

Conditions

Stress, Psychological; Stress Disorders, Post-Traumatic; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: September 27, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Locations

CN (1)