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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 6, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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