Paired Emotion Reading Improves Emotion Regulation in Rural Children With ACE

November 26, 2024 updated by: Yinyin Zang, PhD, Peking University

Paired Emotion Reading Improves Emotion Regulation in Rural Children With Adverse Childhood Experiences: A Cluster Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Peking, Beijing, China, 100871
        • Peking University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the online Paired Emotion Reading Intervention (PERI)
Behavioral: the online Paired Emotion Reading Intervention (PERI)
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.
Active Comparator: the online Paired General Reading Intervention (PGRI)
Behavioral: the online Paired General Reading Intervention (PGRI)
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.
No Intervention: Care as Usual (CAU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotional awareness of rural children
Time Frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
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
Time Frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mental health symptoms of rural children
Time Frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
The investigators examined the effectiveness of PERI on the mental health of rural children using the Strengths and Difficulties Questionnaire (SDQ), including both parent-report and child-report versions, along with three items from the Children's Depression Inventory (CDI) measuring feelings of loneliness. The SDQ comprises five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Relationship Problems, and Prosocial Behavior. Each subscale consists of 5 items rated on a scale of 0-2. Higher scores on each subscale indicate greater difficulties, except for the Prosocial Behavior subscale. Higher score on the items of CDI indicates higher level of loneliness.
baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Resilience of rural children
Time Frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
The investigators explored the effectiveness of PERI on the resilience of rural children through the 10-item Connor-Davidson Resilience Scale. Each item is rated on a 5-point scale, with higher scores indicating higher level of resilience.
baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Self-esteem of rural children
Time Frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
The investigators explored the effectiveness of PERI on the self-esteem of rural children through the Rosenberg self-esteem scale. The total score ranges from 0 to 30, with higher scores indicating greater self-esteem.
baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Emotional awareness of urban children
Time Frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Urban children will complete the Emotional Awareness Questionnaire (EAQ), as rural children did. 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 urban children
Time Frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Urban children will complete the modified subscale of the Emotional Self-Efficacy Scale, as rural children did. 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
Mental health symptoms of urban children
Time Frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
The investigators examined the effectiveness of PERI on the mental health of urban children using the Strengths and Difficulties Questionnaire (SDQ), including both parent-report and child-report versions, along with three items from the Children's Depression Inventory (CDI) measuring feelings of loneliness. The SDQ comprises five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity/Inattention, Peer Relationship Problems, and Prosocial Behavior. Each subscale consists of 5 items rated on a scale of 0-2. Higher scores on each subscale indicate greater difficulties, except for the Prosocial Behavior subscale. Higher score on the items of CDI indicates higher level of loneliness.
baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Resilience of urban children
Time Frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Urban children will complete the 10-item Connor-Davidson Resilience Scale. Each item is rated on a 5-point scale, with higher scores indicating higher level of resilience.
baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Self-esteem of urban children
Time Frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Urban children will complete the Rosenberg self-esteem scale.The total score ranges from 0 to 30, with higher scores indicating greater self-esteem.
baseline, post treatment (6 weeks), 10 weeks, 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2024

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 15, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Paired Reading in ACE Children

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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