Digital Cognitive Behavioral Therapy for Chinese Adolescents with Depressive Symptoms (CADS-D): protocol for a randomized controlled trial

Abstract

Background

Previous studies have confirmed that digital cognitive behavioral therapy (dCBT) is an effective intervention for alleviating depressive symptoms. However, there are no specific dCBT programs available for Chinese adolescents. Therefore, we developed a smartphone-based cognitive behavioral therapy program. This study aims to evaluate the efficacy and feasibility of dCBT for Chinese adolescents with depressive symptoms.

Methods

The Digital Cognitive Behavioral Therapy for Chinese Adolescents with Depressive Symptoms (CADS-D) study is a single-center, two-arm, open-label randomized controlled trial. A total of 200 adolescents aged 12–18 years with depressive symptoms will be recruited. Key exclusion criteria include severe depressive symptoms or suicide risk, comorbid psychiatric disorders other than depressive disorders, severe physical illness or disability preventing dCBT use, current or recent treatment for depression, and inability to complete follow-up. Participants will be randomly assigned to either the intervention group, receiving the 6-week dCBT program MOCA, or the control group, receiving the regular school mental health curriculum. Assessments will be conducted at baseline (T1), post-intervention at week 6 (T2), and at a 3-month follow-up at week 18 (T3). The primary outcome is the change in depressive symptom severity from T1 to T2. Secondary outcomes, assessed at both T2 and T3, include feasibility and changes from baseline in self-reported depressive symptoms, anxiety symptoms, psychological resilience, and quality of life enjoyment and satisfaction. The first participant was enrolled in May 2025, and the study is currently ongoing.

Discussion

Findings from the CADS-D trial will provide empirical evidence regarding the efficacy and feasibility of dCBT among Chinese adolescents. If dCBT proves effective in alleviating depressive symptoms in adolescents, it will enhance therapeutic access for a wider adolescent population in China.

Trial registration

The study was registered with ClinicalTrials.gov (NCT07163013; https://clinicaltrials.gov/study/NCT07163013) on 9 September 2025.

Supplementary Information

The online version contains supplementary material available at https://doi.org/10.1186/s12888-026-08657-y.

Background

Depression is one of the leading causes of disability worldwide and is projected to be the main global burden of disease by 2030 [1]. Epidemiological evidence indicates that the detection rate of depressive symptoms among Chinese adolescents is as high as 24.6% [2]. Previous studies have shown that depressive symptoms in adolescents are associated with various long-term adverse outcomes, including a four- to five-fold higher risk of developing major depressive disorder [3, 4], suicidality [5], and impaired social functioning [6]. Therefore, implementing effective interventions to mitigate depressive symptoms in adolescents is of great public health significance.

Cognitive behavioral therapy (CBT) has been demonstrated to be an effective, evidence-based treatment for depressive symptoms [7], which is recommended as the first-line treatment for adolescents with mild and moderate depression [8]. Traditional CBT typically involves face-to-face sessions between therapists and patients. However, many barriers exist to accessing face-to-face CBT, including location, cost of treatment, long waiting lists, and the stigma of seeking treatment for depressive symptoms, which hinder access for adolescents [9]. Consequently, it is imperative to increase the accessibility of psychotherapy for adolescents.

With the development of internet technology, there is an increasing awareness of digital cognitive behavioral therapy (dCBT) [10]. dCBT is defined broadly as the use of digital tools, platforms or devices to deliver or enhance cognitive behavioral therapy assessment, formulation, treatment, training, and supervision [11]. Over the past decades, numerous dCBT programs designed for adults and adolescents have been shown to be as effective as face-to-face psychotherapy [12–14], such as Moodgym [15], Beating the Blues [16], and SPARX [14, 17]. Moreover, due to the convenience and efficacy of dCBT, current guidelines for the treatment of depression recommend its use in managing mild-to-moderate depression [18]. However, there is currently a lack of dCBT programs specifically tailored for Chinese adolescents, alongside limited evidence concerning their efficacy and feasibility among this population.

To address these problems, we developed a dCBT program, the Moca-Intelligent Psychological Counselling program (MOCA, software copyright No. 2023SR0503207), which is grounded in Beck’s cognitive-behavioral theory [19]. In this six-week randomized controlled trial (RCT) focusing on adolescents with depressive symptoms, we aim to evaluate the efficacy and feasibility of dCBT among Chinese adolescents.

Methods

Study design

CADS-D is a single-center, two-arm, open-label RCT. The intervention group will receive dCBT for 6 weeks, while the control group will receive the regular mental health curriculum delivered by trained school teachers. Assessments of depressive symptoms and other information will be conducted at baseline (week 0, T1), post-intervention (week 6, T2), and the 3-month follow-up (week 18, T3). An overview of the study design is presented in Fig. 1.

Fig. 1.

Flow diagram of study design. Notes: dCBT, Digital Cognitive Behavioral Therapy

Participants

Participating schools will be recruited through nonprofit mental health service collaborations established between the research team and secondary schools in Chongqing, China. Following institutional approval from the school administrators, designated class teachers will receive standardized training on the study information and recruitment procedures. They will then provide students and their guardians with information about the study objectives, procedures, and the voluntary nature of participation. Students and their guardians will also be informed that eligible participants will be individually randomized to one of two school-based mental health programs, without either program being presented as superior. The target population includes adolescents exhibiting depressive symptoms, ranging from subthreshold depressive symptoms to depressive disorders. The inclusion criteria are as follows: (1) age 12 to 18 years; (2) a score of ≥ 28 on the Children’s Depression Rating Scale-Revised (CDRS-R) [20]; (3) ability to read and write in Chinese; (4) provision of written informed consent by the participant and at least one guardian; and (5) access to a smartphone and the internet. Exclusion criteria include: (1) depressive symptoms considered too severe for participation in a school-based dCBT trial (either a CDRS-R T score ≥ 85 [21] or a determination by trained assessors based on the overall clinical assessment); (2) scores ≥ 5 on item 13 (suicidal ideation) on CDRS-R; (3) participants who meet diagnostic criteria for any psychiatric disorder other than depressive disorders, such as bipolar disorder, schizophrenia spectrum disorder, or other diagnosis-level psychiatric comorbidity; (4) severe physical illnesses or other physical disabilities that prevent the use of dCBT; (5) current or recent (within the past three months) treatment for depression, including antidepressant medication, psychotherapy, or physical treatment; or (6) inability to participate in long-term follow-up assessments.

Screening and recruitment assessment

Table 1 presents the schedule of assessments at each time point. All students at participating schools will be offered preliminary online screening using the Center for Epidemiologic Studies Depression Scale for Children (CES-DC) under an opt-out procedure; screening will not proceed if either the student or their guardian declines participation. Designated school staff will communicate individual screening results confidentially to students and their guardians. Adolescents with CES-DC scores ≥ 20 [22] will then be invited to participate in the trial and provided with a separate written informed consent form. After obtaining written informed consent from the student and at least one guardian, trained assessors will conduct eligibility assessments using the CDRS-R and the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children–Present and Lifetime Version (K-SADS-PL) [23, 24]. The CDRS-R assesses depressive symptom severity, whereas the K-SADS-PL determines diagnostic status and identifies exclusionary psychiatric comorbidities.

Table 1.

Schedule of assessments at each time point

Assessments	Measure	Screening and eligibility assessment	T1	T2	T3
Depressive symptoms	CES-DC	√
	CDRS-R	√	√	√	√
	PHQ-9		√	√	√
Anxiety symptoms	GAD-7		√	√	√
Life enjoyment and satisfaction	PQ-LES-Q		√	√	√
Psychological resilience	CD-RISC		√	√	√
Feasibility	Adherence			√
	Completion			√
	Usability			√
	Acceptability			√
	Retention			√	√
Psychiatric disorders	K-SADS-PL	√
Suicide risk	CDRS-R/K-SADS-PL, automated system alerts	Throughout the trial

Notes: CES-DC, the Center for Epidemiologic Studies Depression Scale for Children; CDRS-R, the Children’s Depression Rating Scale-Revised; K-SADS-PL, the Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version; PHQ-9, the 9-item Patient Health Questionnaire; GAD-7, Generalized Anxiety Disorder 7-item Scale; PQ-LES-Q, the Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire; CD-RISC, the Connor-Davidson Resilience Scale; dCBT, Digital Cognitive Behavioral Therapy

Randomization, allocation concealment, and blinding

Participants will be randomly assigned 1:1 to either the dCBT group or the control group after eligibility confirmation. An independent researcher will generate and hold the randomization sequence using a permuted block design (block size of 4) with the blockrand package in R. Recruitment staff will enroll participants and complete baseline assessments without access to the randomization sequence. Group allocation will be disclosed by the independent researcher only after eligibility has been confirmed and baseline assessment has been completed. Due to the nature of the dCBT intervention, it is not feasible to mask participants and providers. Outcome assessors and data analysts will remain masked to group assignments throughout the trial. Participants will be instructed not to disclose their group allocation during assessment sessions. Any instance of assessor unblinding, including the affected participant and relevant circumstances, will be documented.

General intervention procedures

All participants will complete their assigned intervention over a 6-week period, with one session organized each week at the participating school. Trained research assistants will record attendance, reasons for absence, and session completion. Participants in the dCBT group will complete two consecutive MOCA modules during each weekly session, whereas those in the control group will attend one session of the regular school mental health curriculum during the same week. The total duration of exposure to the intervention is matched between the two groups (approximately 40 min per week).

To mitigate potential cross-contamination between groups, school teachers and participants are instructed not to share intervention content, screenshots, or account information with unauthorized individuals. Control group participants have no access to the dCBT system during the trial. For each session, school teachers will notify participants and direct them into separate classrooms or meeting rooms to prevent visual or verbal interaction concerning the study materials. Any reported exposure to materials from the alternative study arm will be documented by the research team.

To optimize retention and follow-up completion, participants in both groups will receive a non-financial incentive valued at 25 CNY after completing the 6-week intervention. An additional incentive of the same value will be provided upon completion of the follow-up assessment.

Intervention group: dCBT program

Participants allocated to the intervention group will receive MOCA, a smartphone-based dCBT program designed for adolescents with depressive symptoms. The curriculum was developed by psychologists based on established CBT principles, with its language, case scenarios, and practice activities adapted to be culturally relevant, developmentally appropriate, and reflective of Chinese adolescents’ everyday experiences. Prior to the trial, MOCA underwent testing and refinement based on usability feedback from adolescents and expert consultation. MOCA comprises 12 structured modules addressing core CBT skills; participants will complete two consecutive modules during each weekly session.

During the initial intervention session, each participant will receive a unique user account pre-registered by the research team. Following login, participants perform a brief emotional assessment and then access the assigned CBT module via Moca, a natural language processing (NLP)-based conversational agent. Core CBT concepts, such as automatic thoughts and cognitive distortions, are delivered through adolescent-friendly multimedia materials, including animations, graphic illustrations, and scenario-based vignettes.

The core therapeutic components, including module sequence, therapeutic goals, psychoeducational materials, and CBT exercises, are standardized for all participants. Conversely, conversational examples and homework recommendations are tailored according to participants’ mood check-ins and self-reported contexts. Personalized homework is generated by matching participants’ reported contexts and selected CBT skills with predefined homework templates embedded in the MOCA system.

The MOCA program also includes safety-related functions such as suicide risk screening and automated crisis-support prompts. Safety alerts generated by the system are reviewed by trained staff and, when necessary, referred to the clinical research team for further assessment. The content of each module is summarized in Table 2, and additional details of the MOCA program are provided in Supplementary Appendix 1.

Table 2.

Overview of the digital cognitive behavioral therapy components

Session	dCBT component	Specific contents
1	Psychoeducation	(1) Provide psychoeducation about mood problems and the basic CBT model linking thoughts, emotions, and behaviors; (2) Guide participants to set personal goals; (3) Introduce mood monitoring as homework.
2	Relaxation training	(1) Introduce relaxation training as a strategy for emotion regulation; (2) Practice diaphragmatic breathing, progressive muscle relaxation, and guided imagery.
3	Behavioral self-monitoring and functional analysis	(1) Help participants identify links between situations, behaviors, and emotional responses; (2) Guide participants to distinguish adaptive and maladaptive behavioral patterns.
4	Behavioral activation	(1) Introduce how emotions and behaviors are interconnected; (2) Guide participants to create a personal to-do list of pleasant activities.
5	Communication and interpersonal skills	(1) Introduce basic communication and interpersonal skills; (2) Practice skills such as initiating conversations, active listening, appropriate humor, and supportive responses.
6	Emotional identification	(1) Introduce how emotions, behaviors, and thoughts are interconnected; (2) Guide adolescents to observe, label, and identify their emotions.
7	Emotion regulation	(1) Introduce strategies for managing intense emotions; (2) Practice skills such as the traffic-light technique and the opposite-action technique.
8	Problem-solving skills	(1) Introduce structured problem-solving strategies; (2) Practice identifying problems, evaluating pros and cons, and applying the STOP (Slow down-Think-Act) strategy.
9	Family psychoeducation and expectation management	(1) Provide psychoeducation about CBT-related concepts in the family context; (2) Guide participants to identify family expectations and set realistic goals for coping with family-related stress.
10	Cognitive restructuring	(1) Introduce the concept of gloomy negative automatic thoughts (GANTs); (2) Guide participants to identify their own GANTs; (3) Practice evaluating and challenging unhelpful thoughts; (4) Generate more balanced alternative thoughts.
11	Mindfulness	(1) Introduce mindfulness-based skills; (2) Practice present-focused awareness and distress-tolerance strategies.
12	Relapse prevention	(1) Review the CBT model and key skills learned during the program; (2) Help participants identify early warning signs; (3) Develop strategies for seeking help and preventing relapse.

Notes: dCBT, Digital Cognitive Behavioral Therapy; CBT, Cognitive Behavioral Therapy

Control group: the regular school mental health curriculum

Participants in the control group will receive the regular school mental health curriculum. The curriculum reflects routine school-based psychosocial support and follows a standardized mental health education framework applicable across participating schools, covering topics such as mental health education, positive psychology, interpersonal skills, self-acceptance, existential meaning, and exam-related stress management. Notably, it does not include dCBT-specific components, such as structured CBT modules and NLP-based conversational interaction. The curriculum is delivered face-to-face by qualified school mental health teachers, who are independent of randomization and outcome assessment. For each control session, the research team will record the session instructor and topic. Any differences in delivery across schools or grades will also be documented and accounted for in descriptive or sensitivity analyses as appropriate.

Safety considerations

A safety monitoring framework will be implemented to safeguard the study population. Potential harms are defined as significant clinical deterioration in mental health or the emergence of acute suicide risk. Suicide risk will be monitored continuously throughout the trial via multi-modal assessments, including automated system alerts, scheduled trial assessments, and reports from school counselors. Participants identified as being at high risk of suicide will discontinue the intervention to prioritize safety and will be referred to specialized psychiatric services for appropriate clinical management. All adverse events and serious adverse events will be systematically documented from enrollment to study completion, and reported to the institutional ethics committee in accordance with regulatory requirements.

Data collection

Demographic characteristics

Demographic information, including age, sex, grade level, and parental marital status, will be collected at baseline.

Primary outcome

The primary outcome is the change in depressive symptom severity from baseline (week 0, T1) to the post-intervention assessment (week 6, T2), assessed via the CDRS-R. The primary estimand is defined as the mean difference between two groups in the change of CDRS-R total scores from T1 to T2. The CDRS-R is a 17-item clinician-rated scale developed to assess depressive symptoms in children and adolescents. Items are rated on either a 5-point or 7-point scale, with higher scores indicating more severe depressive symptoms [21]. The CDRS-R is a validated instrument with robust psychometric properties in Chinese adolescent populations [20]. Evaluations will be performed by trained interviewers blinded to treatment assignment.

Secondary outcome measures

The secondary outcomes include the feasibility of the dCBT intervention; changes from baseline to T2 and T3 in self-reported depressive symptoms, anxiety symptoms, psychological resilience, and quality of life enjoyment and satisfaction scores; and maintenance of the intervention effect, evaluated using the change in CDRS-R score from baseline to T3.

Feasibility

Feasibility will be evaluated across several domains: adherence, completion, retention, usability, and acceptability. Adherence will be defined as participants’ attendance at the scheduled weekly intervention sessions and will be calculated as the percentage of sessions attended during the 6-week intervention period. Completion refers to engagement with the prescribed intervention content and will be assessed using the number and proportion of dCBT modules completed. For modules with homework assignments, homework completion will form part of the module completion assessment and will be automatically recorded by MOCA based on participants’ responses at the beginning of the subsequent module. Retention will be defined as the proportion of participants who complete the post-intervention assessment and the 3-month follow-up assessment.

Usability and acceptability will be assessed using a self-developed feasibility and satisfaction questionnaire designed for this study. The questionnaire includes 8 Likert-scale items and 2 open-ended questions, with the full item list provided in Supplementary Appendix 2. Likert-scale items will be summarized to generate overall feasibility and satisfaction score, with higher scores indicating greater perceived usability and acceptability. Open-ended responses will be summarized to inform intervention refinement.

Self-reported depressive severity

Self-reported depressive symptoms will be assessed using the 9-item Patient Health Questionnaire (PHQ-9). Participants report the frequency of the 9 depressive symptoms outlined in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) over the preceding two weeks. Each item is rated on a 4-point Likert scale ranging from 0 (not at all) to 3 (nearly every day), with total scores ranging from 0 to 27 [25]. The PHQ-9 has shown acceptable reliability and validity in Chinese adolescents [26].

Self-reported anxiety severity

The Generalized Anxiety Disorder 7-item Scale (GAD-7) is a 7-item questionnaire developed to identify probable cases of GAD and measure the severity of GAD symptoms. Participants rate how often they have been bothered by each of the seven core symptoms over the past two weeks using a 4-point Likert scale (0 = not at all; 3 = nearly every day). Total scores range from 0 to 21 [27]. The GAD-7 has also been validated among Chinese adolescents, showing good internal consistency and acceptable construct validity [28].

Psychological resilience

Psychological resilience will be evaluated using the Connor-Davidson Resilience Scale (CD-RISC). This scale consists of 25 items and utilizes a 5-point Likert scale ranging from 0 (not at all true) to 4 (true nearly all of the time). Higher total scores (range 0–100) indicate stronger psychological resilience [29]. The CD-RISC has shown satisfactory internal consistency and validity in Chinese adolescent populations [30].

Quality of life enjoyment and satisfaction

The Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) is a self-report measure designed specifically for children and adolescents. It covers 15 areas of daily life, with items rated on a 5-point Likert scale ranging from 1 (very poor) to 5 (very good), and has shown acceptable reliability and validity in adolescent populations [31].

Data monitoring and confidentiality

Data monitoring is performed by two independent researchers. The data monitoring researchers perform weekly checks, including reviewing progress reports generated by the core research team, to track recruitment milestones and data collection integrity (e.g., completion rates for each follow-up assessment).

The study is conducted strictly in accordance with relevant national and local regulations. To ensure data confidentiality, all collected data will be recorded using a unique participant identification code. Prior to distribution to researchers, all personally identifiable information will be removed from the dataset, ensuring a fully anonymized dataset for analysis. All data are securely stored on encrypted servers at The First Affiliated Hospital of Chongqing Medical University, with access restricted exclusively to authorized personnel.

Sample size

The sample size was determined based on the primary endpoint. Drawing on previous studies of dCBT interventions for adolescent depressive symptoms, which have reported effect sizes ranging from small to large [32, 33], we assumed a moderate effect size of Cohen’s d = 0.45. A power analysis was performed using G*Power 3.1 [34]. Assuming a two-sided α of 0.05, 80% power (β = 0.20), and balanced two-group allocation, a minimum of 80 participants per arm is required. To account for an anticipated attrition rate of approximately 20%, the target sample size is increased to 100 participants per arm, resulting in a total planned sample size of 200 participants.

Statistical analysis plan

Data analysis will adhere to the intention-to-treat principle, with all randomized participants included in the analysis set. Baseline variables will be reported as means ± standard deviations (SD), medians (interquartile ranges), or frequencies and percentages, as appropriate. Between-group baseline comparisons will be performed using independent samples t-tests, Mann-Whitney U tests, chi-square tests, or Fisher’s exact tests based on data distribution and scale.

The primary endpoint and other continuous outcomes will be analyzed using linear mixed-effects models (LMMs). These models will include group, time, and their interaction as fixed effects, with participant-specific random intercepts to account for within-participant correlation across repeated measures. Baseline covariates, including age, sex, and parental marital status, will be incorporated to adjust for potential confounding. Results will be presented as regression coefficients with 95% confidence intervals and P values, supplemented by Cohen’s d for effect sizes. To control for Type I error, Bonferroni corrections will be applied to all secondary outcomes. Furthermore, open-ended feedback will undergo thematic content analysis to identify key facilitators and barriers to implementation.

Before the main analysis, missing data patterns will be compared between groups. The primary analysis will use LMMs, which handle missing observations under the missing-at-random assumption. As a sensitivity check, multiple imputation will be conducted using Rubin’s rules, incorporating treatment group, baseline and follow-up scores, and key demographics. To further evaluate the robustness of findings, we will perform: (1) a per-protocol analysis including participants who complete at least 3 of the 6 weekly sessions and complete the primary endpoint assessment; (2) analyses accounting for school or class-level clustering using random effects; and (3) a prespecified exploratory subgroup analysis by sex. All tests will be two-tailed, with statistical significance set at α = 0.05. Analyses will be conducted using R (version 4.3.0).

Ethics and dissemination

Ethics approval was granted by the ethics committee of the First Affiliated Hospital of Chongqing Medical University (2023-297-02). Written informed consent will be obtained from all participants and at least one of their legal guardians. Participants retain the right to withdraw their consent and discontinue their involvement in the study at any point without providing a justification. Unless the participant explicitly requests removal of their data, information collected prior to their withdrawal will be retained and utilized for the purposes of the study.

The findings of this trial will be disseminated through both professional academic and public-facing channels. We intend to publish the study results in peer-reviewed journals and present findings at national and international conferences. Trial outcomes will be updated on ClinicalTrials.gov in accordance with reporting requirements. Upon study completion, a plain-language summary of the results will be shared with participating schools, participants, and their guardians. Furthermore, key findings may be shared with the broader community through institutional websites, social media, and official press releases.

Discussion

This protocol outlines an RCT involving Chinese adolescents with depressive symptoms, aimed at investigating the efficacy and feasibility of a novel dCBT program named MOCA. The current study addresses several gaps in the existing literature. First, to our knowledge, MOCA represents one of the first smartphone-based dCBT programs specifically tailored for Chinese adolescents. The curriculum has been systematically designed and localized by a multidisciplinary team of psychologists, based on the classical cognitive behavioral therapy theoretical framework, thereby enhancing its suitability for this demographic. Second, from a technical perspective, MOCA integrates multimedia presentations and NLP to guide users through the intervention via an interactive conversational agent. These features may enhance perceived usability and acceptability, potentially reducing barriers to adherence and supporting adolescents’ engagement with digital mental health interventions. Finally, in the current study, depressive symptoms will be assessed by trained interviewers using the CDRS-R rather than relying solely on self-reported measures. This design is expected to provide a more objective and robust evaluation of dCBT efficacy in a school-based setting.

In conclusion, the CADS-D trial aims to introduce a novel delivery model of psychotherapy tailored for Chinese adolescents by developing a dCBT program that incorporates structured CBT modules in an accessible and developmentally appropriate format. The findings of this study are expected to advance the development and application of digital therapy in the field of mental health. If proven effective, this dCBT program could serve as a scalable, accessible, and resource-efficient treatment option for alleviating depressive symptoms among Chinese adolescents.

Supplementary Information

Below is the link to the electronic supplementary material.

Abbreviations

CADS

D Digital Cognitive Behavioral Therapy for Chinese Adolescents with Depressive Symptoms

dCBT

digital Cognitive Behavioral Therapy

CBT

Cognitive Behavioral Therapy

RCT

Randomized Controlled Trial

CDRS-R

The Children’s Depression Rating Scale-Revised

CES-DC

The Center for Epidemiologic Studies Depression Scale for Children

K-SADS-PL

The Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version

NLP

Natural Language Processing

PHQ-9

The 9-item Patient Health Questionnaire

DSM-5

The Diagnostic and Statistical Manual of Mental Disorders, 5th Edition

GAD-7

The Generalized Anxiety Disorder 7-item Scale

CD-RISC

The Connor-Davidson Resilience Scale

PQ-LES-Q

The Paediatric Quality of Life Enjoyment and Satisfaction Questionnaire

LMMs

Linear mixed-effects models

Author contributions

All authors had final responsibility for the decision to submit for publication. XZ is the principal investigator, responsible for this study. TL, XL, NW, and YH contributed to the study design. XZ, XL, and RW supervised the analysis and revised the manuscript. All authors have read and approved the final manuscript. The corresponding author attests that all listed authors meet the criteria for authorship and that no other individuals meeting the criteria have been omitted.

Funding

This work was supported by the National Key R&D Program of China (2024YFC2707800), STI2030-Major Projects (2022ZD0212900), the National Natural Science Foundation of China (82271565), and the Natural Science Foundation of Chongqing, China (CSTB2024NSCQ-LZX0060). The trial sponsor and funders had no role in the design of the study and will not have any role during its execution, analyses, interpretation of the data, nor decision to submit results.

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to participate

The ethics approval was granted by the ethics committee of the First Affiliated Hospital of Chongqing Medical University (2023-297-02). The trial was registered at ClinicalTrials.gov (NCT07163013). Written informed consent will be obtained from all participants and at least one of their guardians. The study procedures comply with the Declaration of Helsinki.

Trial organization, roles, and responsibilities

The First Affiliated Hospital of Chongqing Medical University serves as the coordinating site. The principal investigator and core research team are responsible for the overall study design, trial supervision, safety management, and reporting. Trained research assistants are responsible for participant recruitment, intervention coordination, attendance recording, and follow-up management. Outcome assessors conduct clinical assessments while remaining masked to group allocation. The data management and analysis team is responsible for database maintenance, data monitoring, and masked statistical analysis.

Trial status

Following the receipt of ethical approval, a pilot study was initiated in April 2025. The first participant was enrolled in the RCT in May 2025, and the study is currently ongoing.

Presentations

This research has not been published anywhere before and has not been presented at any congress.

Protocol version

Issue date: September 9th, 2025; Protocol version: 01.

Competing interests

The authors declare no competing interests.