Clinical trial NCT06505629: Paired Emotion Reading Improves Emotion Regulation in Rural Children With ACE
Official title: Paired Emotion Reading Improves Emotion Regulation in Rural Children With Adverse Childhood Experiences: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Emotion Regulation
Adverse Childhood Experience
Keywords: Emotion Regulation
Randomized Controlled Trial
Adverse Childhood Experience
Children
Mental Health
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-07-17
Enrollment: 150
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to explore the feasibility and effectiveness of the online Paired Emotion Reading Intervention (PERI) on the emotion regulation of rural children with adverse childhood experiences (ACE), as compared with the online Paired General Reading Intervention (PGRI) group and a Care as Usual (CAU) control group. This study is a cluster randomized controlled trial and will recruit three rural schools, randomly assigning them to PERI, PGRI, or CAU. Each school will recruit 50 children with ACE. Additionally, the investigators will recruit 150 urban children of similar ages to the rural children. Urban and rural children will be randomly paired to form urban-rural reading groups, reading different types of books and engaging in discussions. It is hypothesized that, after the intervention, rural children in the PERI group will show significantly greater improvements in emotion regulation self-efficacy and emotional awareness compared to the PGRI and CAU groups. These group differences are expected to persist at 1-month and 3-month follow-up assessments.


Eligibility criteria: Inclusion Criteria for rural children:

1. Age between 9 and 15 years;
2. Experience of at least one adverse childhood experience;
3. Independent reading ability in Chinese;
4. Could use electronic devices such as mobile phones, tablets, or computers for online paired reading;
5. Informed consent obtained from both the child and their parents.

Exclusion Criteria for rural children: A past or current diagnosis of a mental disorder.

The inclusion and exclusion criteria for urban children are the same, except they do not need to meet criterion 2.

Primary outcomes:
measure: Emotional awareness of rural children
timeFrame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
measure: Emotion regulation self-efficacy of rural children
timeFrame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Secondary outcomes:
measure: Mental health symptoms of rural children
timeFrame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
measure: Resilience of rural children
timeFrame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
measure: Self-esteem of rural children
timeFrame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
measure: Emotional awareness of urban children
timeFrame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
measure: Emotion regulation self-efficacy of urban children
timeFrame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
measure: Mental health symptoms of urban children
timeFrame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
measure: Resilience of urban children
timeFrame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
measure: Self-esteem of urban children
timeFrame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking University
state: Beijing
Study officials:
References: