Emotion RegulationNCT06505629
Paired Emotion Reading Improves Emotion Regulation in Rural Children With ACE
A study testing the online Paired Emotion Reading Intervention (PERI) and the online Paired General Reading Intervention (PGRI) in people with Emotion Regulation and Adverse Childhood Experience, run by Peking University at 1 site in China.
Trial 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)… Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Adverse Childhood Experience
- What is being tested?
- the online Paired Emotion Reading Intervention (PERI) and the online Paired General Reading Intervention (PGRI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2024to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Emotion Regulation, Adverse Childhood Experience
- Being tested
- the online Paired Emotion Reading Intervention (PERI), the online Paired General Reading Intervention (PGRI)
- Keywords
- Emotion Regulation, Randomized Controlled Trial, Adverse Childhood Experience, Children, Mental Health
- Medical subject headings
- Emotional Regulation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the online Paired Emotion Reading Intervention (PERI)Behavioural
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 General Reading Intervention (PGRI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| the online Paired Emotion Reading Intervention (PERI) | Experimental | Not described Receives: Behavioral: the online Paired Emotion Reading Intervention (PERI) |
| the online Paired General Reading Intervention (PGRI) | Active comparator | Not described Receives: Behavioral: the online Paired General Reading Intervention (PGRI) |
| Care as Usual (CAU) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Secondary outcomes (8)
Mental health symptoms of rural children
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.
Measured: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Resilience of rural children
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.
Measured: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Self-esteem of rural children
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.
Measured: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Emotional awareness of urban children
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.
Measured: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Emotion regulation self-efficacy of urban children
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.
Measured: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Mental health symptoms of urban children
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.
Measured: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Resilience of urban children
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.
Measured: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Self-esteem of urban children
Urban children will complete the Rosenberg self-esteem scale.The total score ranges from 0 to 30, with higher scores indicating greater self-esteem.
Measured: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start6 Jul 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinyin Zang, PhD, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505629
- Sponsor's protocol ID
- Paired Reading in ACE Children
- Status last verified
- Nov 2024
- First submitted
- 4 Jul 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paired Emotion Reading Improves Emotion Regulation in Rural Children With Adverse Childhood Experiences: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06505629
- Acronym / sponsor ID
- Paired Reading in ACE Children
- Conditions
- Emotion Regulation, Adverse Childhood Experience
- Keywords
- Emotion Regulation, Randomized Controlled Trial, Adverse Childhood Experience, Children, Mental Health
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 6 Jul 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | the online Paired Emotion Reading Intervention (PERI) |
| 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. | Behavioural | the online Paired General Reading Intervention (PGRI) |
Primary outcome
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.
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.
8 secondary outcomes
Mental health symptoms of rural children
Time frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Resilience of rural children
Time frame: 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
Emotional awareness of urban children
Time frame: 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
Mental health symptoms of urban children
Time frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks
Resilience of urban children
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the online Paired Emotion Reading Intervention (PERI) and the online Paired General Reading Intervention (PGRI) in people with Emotion Regulation and Adverse Childhood Experience, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional awareness of rural children (time frame: baseline, post treatment (6 weeks), 10 weeks, 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.