NCT06505629

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

July 6, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

9 months

First QC Date

July 4, 2024

Last Update Submit

November 26, 2024

Conditions

Keywords

Emotion RegulationRandomized Controlled TrialAdverse Childhood ExperienceChildrenMental Health

Outcome Measures

Primary Outcomes (2)

  • Emotional awareness of rural children

    The investigators explored the effectiveness of PERI on the emotional awareness of rural children using the Emotional Awareness Questionnaire (EAQ). The EAQ consists of 30 items, each rated on a 3-point scale, with higher scores indicating greater emotional awareness.

    baseline, post treatment (6 weeks), 10 weeks, 18 weeks

  • Emotion regulation self-efficacy of rural children

    The investigators explored the effectiveness of PERI on the emotion regulation self-efficacy of rural children using the modified subscale of the Emotional Self-Efficacy Scale. Each item is rated on a 5-point scale, with higher scores indicating higher self-efficacy in emotion regulation.

    baseline, post treatment (6 weeks), 10 weeks, 18 weeks

Secondary Outcomes (8)

  • Mental health symptoms of rural children

    baseline, post treatment (6 weeks), 10 weeks, 18 weeks

  • Resilience of rural children

    baseline, post treatment (6 weeks), 10 weeks, 18 weeks

  • Self-esteem of rural children

    baseline, post treatment (6 weeks), 10 weeks, 18 weeks

  • Emotional awareness of urban children

    baseline, post treatment (6 weeks), 10 weeks, 18 weeks

  • Emotion regulation self-efficacy of urban children

    baseline, post treatment (6 weeks), 10 weeks, 18 weeks

  • +3 more secondary outcomes

Study Arms (3)

the online Paired Emotion Reading Intervention (PERI)

EXPERIMENTAL
Behavioral: the online Paired Emotion Reading Intervention (PERI)

the online Paired General Reading Intervention (PGRI)

ACTIVE COMPARATOR
Behavioral: the online Paired General Reading Intervention (PGRI)

Care as Usual (CAU)

NO INTERVENTION

Interventions

In the PERI, all children will receive three books about emotion knowledge. The paired reading groups will read and discuss these books over the next six weeks. Before starting the reading sessions, the paired groups will meet online via video to get to know each other and set reading goals. During the reading process, participants will check in daily with their reading progress. From the second week to the fifth week, participants will engage in weekly online discussions about the reading content. These discussions, led by the urban children, will follow a semi-structured discussion guide. The discussions aim to deepen the children's understanding of the book content and facilitate the application of emotion-related knowledge and emotion regulation strategies in their daily lives. The discussion sessions will be recorded and uploaded for regular review by the researchers.

the online Paired Emotion Reading Intervention (PERI)

Apart from the differences in the reading materials and discussion topics, all other aspects are identical to the PERI group. In the online PGRI, children will read three books of their choice, and discussions will center around general reading experiences and feelings.

the online Paired General Reading Intervention (PGRI)

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100871, China

Location

MeSH Terms

Conditions

Emotional RegulationPsychological Well-Being

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehaviorPersonal Satisfaction

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2024

First Posted

July 17, 2024

Study Start

July 6, 2024

Primary Completion

March 30, 2025

Study Completion

August 30, 2025

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations