Clinical trial NCT06619821: Effects of Parent-Adolescent Joint Interventions for Adolescents With Adverse Childhood Experiences
Official title: Effects of Parent-Adolescent Joint Interventions for Adolescents With Adverse Childhood Experiences: A Multi-Center Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stress, Emotional
Stress-related Mental Disorders
Adverse Childhood Experiences
Keywords: adolescents
randomized controlled trial
PTSD
ACE
depression
anxiety
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 3000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Alexithymia
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: PTSD for adolescents
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Emotion awareness
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Emotion regulation
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Depression
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Generalized anxiety disorder
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
Secondary outcomes:
measure: Irritability
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Resilience
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Seeking for help
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Insomnia Severity
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
Other outcomes:
measure: Suicide
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Self-esteem
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Social support
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Subjective Happiness Scale
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Subjective Units of Distress Scale
timeFrame: each week during intervention (up to 4 months)
measure: Positive Childhood Experiences
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Game Addiction Scale
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Behavior performances
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Adverse events
timeFrame: baseline, post treatment(1 month)
measure: Meaning in life
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Non-suicidal self-injury
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Self-esteem stability
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Somatic problems
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Problematic Internet use
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
measure: Adverse Childhood Experiences
timeFrame: baseline, post treatment(1 month), 3 month after post treatment
Locations:
city: Baoding
country: China
facility: Biancun middle school
state: Hebei
city: Baoding
country: China
facility: Diannan middle school
state: Hebei
Study officials:
References: