Psychosocial InterventionNCT07325890
Research on the Application of Decision Tree in Child Life
A study testing decision tree for Child Life and Routine Child Life intervention for children in people with Psychosocial Intervention and Non-Randomized Controlled Trials, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The purpose of this study is to understand whether the decision tree for Child Life is effective in improving the professional level and working effect of Child Life Specialists. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosocial Intervention, Non-Randomized Controlled Trials
- What is being tested?
- decision tree for Child Life and Routine Child Life intervention for children
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 20 Mar 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have received training in relevant courses on Child Life.
- Have been engaged in clinical practice of Child Life for at least one year.
Who cannot join
- Those who are currently on internship, in further education, or not directly involved in clinical treatment.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to understand whether the decision tree for Child Life is effective in improving the professional level and working effect of Child Life Specialists. The main questions it aims to answer are:
- Does the decision tree for Child Life enhance the professional knowledge level of Child Life Specialists?
- Has the decision tree for Child Life improved the work effectiveness of Child Life Specialists?
- Has the application of Child Life decision trees improved children's pain levels and compliance?
Read more
Researchers will compare the intervention group and the observation group to see if the decision tree for Child Life can enhance the professional level and work effectiveness of Child Life Specialists.
Participants in the intervention group will:
- Receive training on the application of decision trees for Child Life.
- Apply the decision tree for Child Life to carry out intervention in Child Life intervention.
- Participate in knowledge level tests, work effect evaluations, and record the pain levels and compliance of pediatric patients.
Participants in active comparator will:
- Conduct Child Life intervention based on one's own experience and professional level.
- Participate in knowledge level tests, work effect evaluations, and record the pain levels and compliance of pediatric patients.
Read the detailed description
Psychosocial issues, such as behavioral problems, social interaction disorders and learning difficulties, have become important topics in children's health care. These problems not only affect the immediate recovery of the child patients and increase the risk of complications such as delirium, but may also have a profound negative impact on their long-term development.
The application of decision tree for Child Life can provide clinical workers with effective and feasible intervention strategies, promote the standardization of Child Life practices, thereby reducing the psychological trauma of hospitalization on children and improving the overall quality of care for pediatric patients.
This study adopted a non-randomized controlled study and the intervention was carried out at Fudan University Children's Hospital.
Tools such as the "Questionnaire on Knowledge Level of Child Life Specialists" and the "Questionnaire on Evaluation of Work Effect of Child Life Specialists" were used to evaluate the two groups before and after the training respectively, and children's information of the included cases was collected during the process.
- Being tested
- decision tree for Child Life, Routine Child Life intervention for children
- Keywords
- Child Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decision tree for Child LifeOther
Four training sessions on decision tree for Child Life were conducted for Child Life Specialists. The training content was produced by the research team based on previous literature and clinical experience. After the training, Child Life Specialists will apply the Child Life decision tree in clinical practice to carry out Child Life intervention.
Routine Child Life intervention for childrenOther
Child Life Specialists will conduct Child Life intervention for children based on their professional knowledge and clinical experience in clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Applying decision tree of Child Life for children | Experimental | (1) The decision tree for Child Life was applied to conduct Child Life intervention for the children included in the event. (2) The knowledge level of Child Life Specialists was collected before and after the application. (3) The compliance and pain level of the children included in the event were collected. (4) The working effect of Child Life Specialists was cross-evaluated by two Certified Child Life Specialists. Receives: Other: decision tree for Child Life |
| Routine Child Life intervention for children | Active comparator | (1) Routine Child Life intervention was applied for the children included in the event. (2) The knowledge level of Child Life Specialists was collected before and after the application. (3) The compliance and pain level of the children included in the event were collected. (4) The working effect of Child Life Specialists was cross-evaluated by two Certified Child Life Specialists. Receives: Other: Routine Child Life intervention for children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical anxiety and cooperative behavior manifestations of the child patient
Before and after each intervention, researchers collected on-site the clinical anxiety and cooperative behavior manifestations of the children included in the intervention plan. The scoring range of this scale is from 0 to 5, with a total of six points. A score of 0 indicates ease, 1 indicates discomfort, 2 indicates tension, 3 indicates reluctance, 4 indicates fear, and 5 indicates loss of control. The higher the score, the more resistant the child is to treatment and the poorer the degree of cooperation. It is generally believed that children with a score of 4 or 5 are unable to cooperate with the treatment.
Measured: From enrollment to the end of intervention at 2 months
Secondary outcomes (4)
Questionnaire on Knowledge of Child Life Specialists
This questionnaire is derived from the ACLP Child Life Specialists(CLS) Knowledge Question Bank, aiming to assist the CLS system in mastering the psychological support, developmental-appropriate care, and service skills required by the profession. In this study, 25 questions were randomly selected from the total question bank to form an online questionnaire. The total score of the questionnaire is set at 100 points, with 4 points assigned to each question, which is used to test the knowledge level of CLS.
Measured: From enrollment to the end of training at 2 months
Questionnaire on the Evaluation of the Work Effect of Child Life Specialists
The content of this questionnaire is based on the ability evaluation list of Child Life Specialists provided by St. Jude Children's Hospital in the United States. It is based on six dimensions: assessment, games, psychological preparation, procedural support, medical education, and family support. Two CCLS who have been trained and certified by the ACLP system are respectively evaluated for their performance in all modules, professional spirit, and overall practical performance. Provide a summary comment and final rating, which are classified into four categories: poor, average, good, and very good.
Measured: Each intervention ended after enrollment
Competency Level of Child Life Specialists
To comprehensively and objectively assess the ability level of Child Life Specialists(CLS) in clinical practice, the research team, based on Dreyfus' skill acquisition model, divided the professional ability of CLS into four consecutive development stages: novice level, advanced beginner level, competent level and proficient level. Cross-validation through simultaneous evaluation by two CCLS is conducted to truly reflect the professional maturity of CLS in complex clinical contexts.
Measured: From enrollment to the end of training at 2 months
FACES Pain Scale
FACES Pain Scale in this study was only conducted in specific clinical situations that might cause pain in the children. Specifically, the children patients will be independently evaluated by two trained researchers to ensure the reliability and accuracy of the scores. During this assessment process, researchers comprehensively judged the degree of pain of the children based on their behavioral responses and verbal expressions, and marked the corresponding scores on the visual analogue scale.
Measured: From enrollment to the end of intervention at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Dec 2025
- Primary completion31 Jan 2026
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial InterventionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325890
- Sponsor's protocol ID
- CHFudanU1212
- Status last verified
- Mar 2026
- First submitted
- 25 Dec 2025
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Application of Decision Tree in Child Life
- ClinicalTrials.gov ID
- NCT07325890
- Acronym / sponsor ID
- CHFudanU1212
- Keywords
- Child Life
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 8 Jan 2026 (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 purpose of this study is to understand whether the decision tree for Child Life is effective in improving the professional level and working effect of Child Life Specialists. The main questions it aims to answer are:
- Does the decision tree for Child Life enhance the professional knowledge level of Child Life Specialists?
- Has the decision tree for Child Life improved the work effectiveness of Child Life Specialists?
- Has the application of Child Life decision trees improved children's pain levels and compliance?
Researchers will compare the intervention group and the observation group to see if the decision tree for Child Life can enhance the professional level and work effectiveness of Child Life Specialists.
Participants in the intervention group will:
- Receive training on the application of decision trees for Child Life.
- Apply the decision tree for Child Life to carry out intervention in Child Life intervention.
- Participate in knowledge level tests, work effect evaluations, and record the pain levels and compliance of pediatric patients.
Participants in active comparator will:
- Conduct Child Life intervention based on one's own experience and professional level.
- Participate in knowledge level tests, work effect evaluations, and record the pain levels and compliance of pediatric patients.
Detailed description
Psychosocial issues, such as behavioral problems, social interaction disorders and learning difficulties, have become important topics in children's health care. These problems not only affect the immediate recovery of the child patients and increase the risk of complications such as delirium, but may also have a profound negative impact on their long-term development.
The application of decision tree for Child Life can provide clinical workers with effective and feasible intervention strategies, promote the standardization of Child Life practices, thereby reducing the psychological trauma of hospitalization on children and improving the overall quality of care for pediatric patients.
This study adopted a non-randomized controlled study and the intervention was carried out at Fudan University Children's Hospital.
Tools such as the "Questionnaire on Knowledge Level of Child Life Specialists" and the "Questionnaire on Evaluation of Work Effect of Child Life Specialists" were used to evaluate the two groups before and after the training respectively, and children's information of the included cases was collected during the process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Applying decision tree of Child Life for children | Experimental | Other: decision tree for Child Life(1) The decision tree for Child Life was applied to conduct Child Life intervention for the children included in the event. (2) The knowledge level of Child Life Specialists was collected before and after the application. (3) The compliance and pain level of the children included in the event were collected. (4) The working effect of Child Life Specialists was cross-evaluated by two Certified Child Life Specialists. |
| Routine Child Life intervention for children | Active comparator | Other: Routine Child Life intervention for children(1) Routine Child Life intervention was applied for the children included in the event. (2) The knowledge level of Child Life Specialists was collected before and after the application. (3) The compliance and pain level of the children included in the event were collected. (4) The working effect of Child Life Specialists was cross-evaluated by two Certified Child Life Specialists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have received training in relevant courses on Child Life.
- Have been engaged in clinical practice of Child Life for at least one year.
Key exclusion criteria (1 listed)
- Those who are currently on internship, in further education, or not directly involved in clinical treatment.
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 |
|---|---|---|
| decision tree for Child LifeFour training sessions on decision tree for Child Life were conducted for Child Life Specialists. The training content was produced by the research team based on previous literature and clinical experience. After the training, Child Life Specialists will apply the Child Life decision tree in clinical practice to carry out Child Life intervention. | Other | Applying decision tree of Child Life for children |
| Routine Child Life intervention for childrenChild Life Specialists will conduct Child Life intervention for children based on their professional knowledge and clinical experience in clinical practice. | Other | Routine Child Life intervention for children |
Primary outcome
Clinical anxiety and cooperative behavior manifestations of the child patient
Time frame: From enrollment to the end of intervention at 2 months
Before and after each intervention, researchers collected on-site the clinical anxiety and cooperative behavior manifestations of the children included in the intervention plan. The scoring range of this scale is from 0 to 5, with a total of six points. A score of 0 indicates ease, 1 indicates discomfort, 2 indicates tension, 3 indicates reluctance, 4 indicates fear, and 5 indicates loss of control. The higher the score, the more resistant the child is to treatment and the poorer the degree of cooperation. It is generally believed that children with a score of 4 or 5 are unable to cooperate with the treatment.
4 secondary outcomes
Questionnaire on Knowledge of Child Life Specialists
Time frame: From enrollment to the end of training at 2 months
Questionnaire on the Evaluation of the Work Effect of Child Life Specialists
Time frame: Each intervention ended after enrollment
Competency Level of Child Life Specialists
Time frame: From enrollment to the end of training at 2 months
FACES Pain Scale
Time frame: From enrollment to the end of intervention at 2 months
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 23 Mar 2026.
- Individual participant dataSharing planned: No
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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 decision tree for Child Life and Routine Child Life intervention for children in people with Psychosocial Intervention and Non-Randomized Controlled Trials, run by Children's Hospital of Fudan 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 2 inclusion and 1 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 23 Mar 2026. 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?
Clinical anxiety and cooperative behavior manifestations of the child patient (time frame: From enrollment to the end of intervention at 2 months). 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 23 Mar 2026.