Classroom Attention-Related BehaviorNCT07719803
Grade-Specific Effects of Recess HIIT and MICT on Classroom Attention-Related Behavior in Primary School Children
A study testing High-Intensity Interval Training During School Recess and Moderate-Intensity Continuous Training During School Recess in people with Classroom Attention-Related Behavior and School-Based Physical Activity, run by Shanghai University of Sport at 1 site in China.
Trial summary
This randomized controlled trial evaluated whether structured exercise during school recess could improve observable classroom attention-related behavior in primary school children and whether the effects differed between grade levels. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Classroom Attention-Related Behavior, School-Based Physical Activity
- What is being tested?
- High-Intensity Interval Training During School Recess and Moderate-Intensity Continuous Training During School Recess
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2026to 2 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Students enrolled in the third or fifth grade at the participating primary school.
- Aged 8 to 12 years.
- Able to participate in routine physical education classes and school recess activities.
- Free from musculoskeletal injury or any medical condition that contraindicated participation in physical exercise.
- Written informed consent provided by a parent or legal guardian.
- Verbal assent provided by the participating child.
- Willing and able to complete the baseline assessment, exercise intervention, and post-intervention assessment.
Who cannot join
- Musculoskeletal injury, cardiovascular disease, respiratory disease, neurological disorder, or other medical condition that made participation in moderate- or high-intensity exercise unsafe.
- A diagnosed attention-deficit/hyperactivity disorder, autism spectrum disorder, anxiety disorder, depressive disorder, intellectual disability, or other psychological or developmental condition that could substantially affect participation or assessment of classroom attention-related behavior.
- Color blindness or another visual impairment that could interfere with the study assessments.
- Participation in a structured high-intensity exercise training program during the 3 months before enrollment.
- Regular participation in systematic extracurricular exercise training that could substantially affect the intervention response.
- Inability to complete the intervention or study assessments.
- Absence from three or more intervention sessions.
- Withdrawal of parental or guardian consent or withdrawal of the child's assent.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai University of Sport
Shanghai, Shanghai Municipality, 200438
About this study
Official title: Grade-Specific Effects of HIIT and MICT During School Recess on Observable Classroom Attention-Related Behavior in Primary School Children: A Randomized Controlled Trial
This randomized controlled trial evaluated whether structured exercise during school recess could improve observable classroom attention-related behavior in primary school children and whether the effects differed between grade levels.
A total of 144 third- and fifth-grade students were randomly assigned to one of three groups: high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or routine recess activity. The intervention lasted 6 weeks and was conducted three times per week during scheduled school recess. Each structured exercise session lasted 15 minutes, including warm-up, a 9-minute main exercise component, and cool-down.
Observable classroom attention-related behavior was assessed before and after the intervention using an automated video-based behavioral analysis system. The system evaluated observable indicators including head posture, eye gaze, eye opening or closing, and facial detection persistence. The study compared changes among the three groups and examined whether the effects of HIIT and MICT differed between third- and fifth-grade students.
Read the detailed description
This study used a randomized, pretest-posttest, three-arm controlled design to investigate the grade-specific effects of high-intensity interval training and moderate-intensity continuous training conducted during school recess on observable classroom attention-related behavior in primary school children.
Participants were third- and fifth-grade students recruited from a primary school in Shanghai, China. After baseline assessment, 144 eligible children were randomly allocated in a 1:1:1 ratio to the high-intensity interval training group, the moderate-intensity continuous training group, or the routine recess control group, with 48 participants in each group. Randomization was performed at the individual level using a computer-generated sequence and was stratified by grade and sex. The allocation sequence was generated by an independent researcher, and assignments were concealed in sequentially numbered, sealed opaque envelopes.
The study lasted 8 weeks. Week 1 included familiarization and baseline assessments. Weeks 2 through 7 comprised the formal 6-week intervention, and Week 8 included post-intervention assessment. The exercise interventions were delivered three times per week during scheduled school recess, for a total of 18 sessions.
Each structured exercise session lasted 15 minutes and consisted of a 3-minute preparatory activity, a 9-minute main exercise component, and a 3-minute cool-down. Exercise intensity was monitored in real time using heart rate monitors.
The high-intensity interval training group performed interval circuit exercises consisting of jumping jacks, cross jumps, vertical jumps, and burpees. Each exercise was performed for 30 seconds followed by 30 seconds of recovery. The target intensity during the main exercise component was at least 85% of age-predicted maximal heart rate.
The moderate-intensity continuous training group performed continuous aerobic running during the 9-minute main exercise component. The target intensity was maintained at 60% to 69% of age-predicted maximal heart rate.
The control group continued routine school recess activities without receiving additional structured exercise. Routine activities included walking, free play, standing rest, and other usual school-arranged recess behaviors.
The primary outcome was the change in observable classroom attention-related behavior from baseline to post-intervention. Classroom behavior was assessed using an automated video-based analysis system that extracted four observable indicators: head posture, eye gaze, eye opening or closing status, and facial detection persistence. These indicators were standardized and integrated into a composite score, with higher scores indicating greater consistency with classroom-oriented behavior.
The composite score was interpreted as an ecological proxy measure of observable classroom attention-related behavior rather than a direct measure of internal cognitive attention. The primary statistical analysis examined the effects of time, intervention group, grade level, and their interactions, with particular emphasis on the Time × Group × Grade interaction.
Because of the nature of the exercise interventions, participants and exercise instructors were not blinded. However, personnel responsible for video data processing and statistical analysis were not involved in intervention delivery and followed standardized assessment procedures.
- Being tested
- High-Intensity Interval Training During School Recess, Moderate-Intensity Continuous Training During School Recess
- Keywords
- High-Intensity Interval Training, Moderate-Intensity Continuous Training, School Recess, Classroom Attention, Attention-Related Behavior, Primary School Children, Grade-Specific Effects, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Interval Training During School RecessBehavioural
Participants completed a structured high-intensity interval training program during scheduled school recess for 6 weeks, with three sessions per week and 18 sessions in total. Each 15-minute session included a 3-minute warm-up, a 9-minute main exercise component, and a 3-minute cool-down. The main component consisted of jumping jacks, cross jumps, vertical jumps, and burpees. Each movement was performed for 30 seconds followed by 30 seconds of recovery, using a 1:1 work-to-rest ratio. The sequence was completed twice, with a 1-minute rest between sets. Exercise intensity was monitored using heart rate monitors, and the target intensity during the main component was at least 85% of age-predicted maximal heart rate.
Moderate-Intensity Continuous Training During School RecessBehavioural
Participants completed a structured moderate-intensity continuous training program during scheduled school recess for 6 weeks, with three sessions per week and 18 sessions in total. Each 15-minute session included a 3-minute warm-up, 9 minutes of continuous aerobic running, and a 3-minute cool-down. Exercise intensity was monitored using heart rate monitors, and the target intensity during the continuous running component was maintained at 60% to 69% of age-predicted maximal heart rate. Running speed and rhythm were adjusted according to real-time heart rate responses and participant tolerance.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Interval Training (HIIT) Group | Experimental | Participants received a structured high-intensity interval training program during scheduled school recess for 6 weeks, three sessions per week, for a total of 18 sessions. Each 15-minute session included a 3-minute warm-up, a 9-minute HIIT component, and a 3-minute cool-down. The HIIT component consisted of jumping jacks, cross jumps, vertical jumps, and burpees. Each movement was performed for 30 seconds followed by 30 seconds of recovery. The sequence was completed twice, with a 1-minute rest between sets. The target intensity during the main exercise component was at least 85% of age-predicted maximal heart rate. Receives: Behavioral: High-Intensity Interval Training During School Recess |
| Moderate-Intensity Continuous Training (MICT) Group | Active comparator | Participants received a structured moderate-intensity continuous training program during scheduled school recess for 6 weeks, three sessions per week, for a total of 18 sessions. Each 15-minute session included a 3-minute warm-up, 9 minutes of continuous aerobic running, and a 3-minute cool-down. The target intensity during the continuous running component was maintained at 60% to 69% of age-predicted maximal heart rate. Heart rate was monitored during each session to confirm adherence to the prescribed exercise intensity. Receives: Behavioral: Moderate-Intensity Continuous Training During School Recess |
| Routine Recess Control Group | No intervention | Participants continued the routine recess activities arranged by the school and received no additional structured exercise intervention. Routine activities included walking, free play, standing rest, and other usual unstructured or school-arranged recess behaviors. Participants followed the same school schedule as the two structured exercise groups and returned to classroom learning at the same time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Composite Observable Classroom Attention-Related Behavior Score
Observable classroom attention-related behavior was assessed using an automated video-based behavioral analysis system. The system standardized the individual behavioral indicators and integrated them into a composite score. Higher scores indicate greater consistency with classroom-oriented behaviors, including instructional orientation, visual engagement, observable alertness, and maintenance of a classroom-facing position. The outcome was the change in the composite score from baseline to post-intervention.
Measured: Baseline and immediately after the 6-week intervention at Week 8
Secondary outcomes (4)
Change in Head Posture Score
Head posture was assessed using the automated video-based behavioral analysis system. The indicator reflects the participant's physical orientation toward instructional targets during classroom activities. The system generated a standardized head posture score, with higher scores indicating more consistent orientation toward instructional targets. The outcome was the change in the score from baseline to post-intervention.
Measured: Baseline and immediately after the 6-week intervention at Week 8
Change in Eye Gaze Score
Eye gaze was assessed using the automated video-based behavioral analysis system. The indicator reflects the participant's visual orientation toward classroom learning areas. The system generated a standardized eye gaze score, with higher scores indicating more sustained visual orientation toward classroom learning areas. The outcome was the change in the score from baseline to post-intervention.
Measured: Baseline and immediately after the 6-week intervention at Week 8
Change in Eye Opening and Closing Status Score
Eye opening and closing status was assessed using the automated video-based behavioral analysis system. This indicator reflects observable alertness-related behavior during classroom activities. The system generated a standardized score, with higher scores indicating greater consistency with an observable alert and eyes-open state. The outcome was the change in the score from baseline to post-intervention.
Measured: Baseline and immediately after the 6-week intervention at Week 8
Change in Facial Detection Persistence Score
Facial detection persistence was assessed using the automated video-based behavioral analysis system. This indicator reflects whether the participant maintained a detectable classroom-facing position during classroom activities. The system generated a standardized score, with higher scores indicating greater persistence of a detectable classroom-facing position. The outcome was the change in the score from baseline to post-intervention.
Measured: Baseline and immediately after the 6-week intervention at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start23 Jul 2026
- Primary completion2 Sep 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classroom Attention-Related BehaviorStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were individually randomized in a 1:1:1 ratio to the high-intensity interval training, moderate-intensity continuous training, or routine recess control group. Randomization was stratified by grade and sex. The three groups received their assigned recess activities concurrently during the 6-week intervention period.
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Rangxi, Shanghai University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07719803
- Sponsor's protocol ID
- 102772023RT094
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves minors and includes video-derived behavioral data that may carry a risk of participant re-identification. De-identified aggregate results will be reported in scientific publications.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grade-Specific Effects of HIIT and MICT During School Recess on Observable Classroom Attention-Related Behavior in Primary School Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07719803
- Acronym / sponsor ID
- 102772023RT094
- Keywords
- High-Intensity Interval Training, Moderate-Intensity Continuous Training, School Recess, Classroom Attention, Attention-Related Behavior, Primary School Children, Grade-Specific Effects, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Shanghai University of SportUniversity, hospital or other
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 22 Jul 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.
This randomized controlled trial evaluated whether structured exercise during school recess could improve observable classroom attention-related behavior in primary school children and whether the effects differed between grade levels.
A total of 144 third- and fifth-grade students were randomly assigned to one of three groups: high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or routine recess activity. The intervention lasted 6 weeks and was conducted three times per week during scheduled school recess. Each structured exercise session lasted 15 minutes, including warm-up, a 9-minute main exercise component, and cool-down.
Observable classroom attention-related behavior was assessed before and after the intervention using an automated video-based behavioral analysis system. The system evaluated observable indicators including head posture, eye gaze, eye opening or closing, and facial detection persistence. The study compared changes among the three groups and examined whether the effects of HIIT and MICT differed between third- and fifth-grade students.
Detailed description
This study used a randomized, pretest-posttest, three-arm controlled design to investigate the grade-specific effects of high-intensity interval training and moderate-intensity continuous training conducted during school recess on observable classroom attention-related behavior in primary school children.
Participants were third- and fifth-grade students recruited from a primary school in Shanghai, China. After baseline assessment, 144 eligible children were randomly allocated in a 1:1:1 ratio to the high-intensity interval training group, the moderate-intensity continuous training group, or the routine recess control group, with 48 participants in each group. Randomization was performed at the individual level using a computer-generated sequence and was stratified by grade and sex. The allocation sequence was generated by an independent researcher, and assignments were concealed in sequentially numbered, sealed opaque envelopes.
The study lasted 8 weeks. Week 1 included familiarization and baseline assessments. Weeks 2 through 7 comprised the formal 6-week intervention, and Week 8 included post-intervention assessment. The exercise interventions were delivered three times per week during scheduled school recess, for a total of 18 sessions.
Each structured exercise session lasted 15 minutes and consisted of a 3-minute preparatory activity, a 9-minute main exercise component, and a 3-minute cool-down. Exercise intensity was monitored in real time using heart rate monitors.
The high-intensity interval training group performed interval circuit exercises consisting of jumping jacks, cross jumps, vertical jumps, and burpees. Each exercise was performed for 30 seconds followed by 30 seconds of recovery. The target intensity during the main exercise component was at least 85% of age-predicted maximal heart rate.
The moderate-intensity continuous training group performed continuous aerobic running during the 9-minute main exercise component. The target intensity was maintained at 60% to 69% of age-predicted maximal heart rate.
The control group continued routine school recess activities without receiving additional structured exercise. Routine activities included walking, free play, standing rest, and other usual school-arranged recess behaviors.
The primary outcome was the change in observable classroom attention-related behavior from baseline to post-intervention. Classroom behavior was assessed using an automated video-based analysis system that extracted four observable indicators: head posture, eye gaze, eye opening or closing status, and facial detection persistence. These indicators were standardized and integrated into a composite score, with higher scores indicating greater consistency with classroom-oriented behavior.
The composite score was interpreted as an ecological proxy measure of observable classroom attention-related behavior rather than a direct measure of internal cognitive attention. The primary statistical analysis examined the effects of time, intervention group, grade level, and their interactions, with particular emphasis on the Time × Group × Grade interaction.
Because of the nature of the exercise interventions, participants and exercise instructors were not blinded. However, personnel responsible for video data processing and statistical analysis were not involved in intervention delivery and followed standardized assessment procedures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were individually randomized in a 1:1:1 ratio to the high-intensity interval training, moderate-intensity continuous training, or routine recess control group. Randomization was stratified by grade and sex. The three groups received their assigned recess activities concurrently during the 6-week intervention period.
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Interval Training (HIIT) Group | Experimental | Behavioral: High-Intensity Interval Training During School RecessParticipants received a structured high-intensity interval training program during scheduled school recess for 6 weeks, three sessions per week, for a total of 18 sessions. Each 15-minute session included a 3-minute warm-up, a 9-minute HIIT component, and a 3-minute cool-down. The HIIT component consisted of jumping jacks, cross jumps, vertical jumps, and burpees. Each movement was performed for 30 seconds followed by 30 seconds of recovery. The sequence was completed twice, with a 1-minute rest between sets. The target intensity during the main exercise component was at least 85% of age-predicted maximal heart rate. |
| Moderate-Intensity Continuous Training (MICT) Group | Active comparator | Behavioral: Moderate-Intensity Continuous Training During School RecessParticipants received a structured moderate-intensity continuous training program during scheduled school recess for 6 weeks, three sessions per week, for a total of 18 sessions. Each 15-minute session included a 3-minute warm-up, 9 minutes of continuous aerobic running, and a 3-minute cool-down. The target intensity during the continuous running component was maintained at 60% to 69% of age-predicted maximal heart rate. Heart rate was monitored during each session to confirm adherence to the prescribed exercise intensity. |
| Routine Recess Control Group | No intervention | –Participants continued the routine recess activities arranged by the school and received no additional structured exercise intervention. Routine activities included walking, free play, standing rest, and other usual unstructured or school-arranged recess behaviors. Participants followed the same school schedule as the two structured exercise groups and returned to classroom learning at the same time. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Students enrolled in the third or fifth grade at the participating primary school.
- Aged 8 to 12 years.
- Able to participate in routine physical education classes and school recess activities.
- Free from musculoskeletal injury or any medical condition that contraindicated participation in physical exercise.
- Written informed consent provided by a parent or legal guardian.
Key exclusion criteria (8 listed)
- Musculoskeletal injury, cardiovascular disease, respiratory disease, neurological disorder, or other medical condition that made participation in moderate- or high-intensity exercise unsafe.
- A diagnosed attention-deficit/hyperactivity disorder, autism spectrum disorder, anxiety disorder, depressive disorder, intellectual disability, or other psychological or developmental condition that could substantially affect participation or assessment of classroom attention-related behavior.
- Color blindness or another visual impairment that could interfere with the study assessments.
- Participation in a structured high-intensity exercise training program during the 3 months before enrollment.
- Regular participation in systematic extracurricular exercise training that could substantially affect the intervention response.
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 |
|---|---|---|
| High-Intensity Interval Training During School RecessParticipants completed a structured high-intensity interval training program during scheduled school recess for 6 weeks, with three sessions per week and 18 sessions in total. Each 15-minute session included a 3-minute warm-up, a 9-minute main exercise component, and a 3-minute cool-down. The main component consisted of jumping jacks, cross jumps, vertical jumps, and burpees. Each movement was performed for 30 seconds followed by 30 seconds of recovery, using a 1:1 work-to-rest ratio. The sequence was completed twice, with a 1-minute rest between sets. Exercise intensity was monitored using heart rate monitors, and the target intensity during the main component was at least 85% of age-predicted maximal heart rate. | Behavioural | High-Intensity Interval Training (HIIT) Group |
| Moderate-Intensity Continuous Training During School RecessParticipants completed a structured moderate-intensity continuous training program during scheduled school recess for 6 weeks, with three sessions per week and 18 sessions in total. Each 15-minute session included a 3-minute warm-up, 9 minutes of continuous aerobic running, and a 3-minute cool-down. Exercise intensity was monitored using heart rate monitors, and the target intensity during the continuous running component was maintained at 60% to 69% of age-predicted maximal heart rate. Running speed and rhythm were adjusted according to real-time heart rate responses and participant tolerance. | Behavioural | Moderate-Intensity Continuous Training (MICT) Group |
Primary outcome
Change in Composite Observable Classroom Attention-Related Behavior Score
Time frame: Baseline and immediately after the 6-week intervention at Week 8
Observable classroom attention-related behavior was assessed using an automated video-based behavioral analysis system. The system standardized the individual behavioral indicators and integrated them into a composite score. Higher scores indicate greater consistency with classroom-oriented behaviors, including instructional orientation, visual engagement, observable alertness, and maintenance of a classroom-facing position. The outcome was the change in the composite score from baseline to post-intervention.
4 secondary outcomes
Change in Head Posture Score
Time frame: Baseline and immediately after the 6-week intervention at Week 8
Change in Eye Gaze Score
Time frame: Baseline and immediately after the 6-week intervention at Week 8
Change in Eye Opening and Closing Status Score
Time frame: Baseline and immediately after the 6-week intervention at Week 8
Change in Facial Detection Persistence Score
Time frame: Baseline and immediately after the 6-week intervention at Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves minors and includes video-derived behavioral data that may carry a risk of participant re-identification. De-identified aggregate results will be reported in scientific publications.
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 High-Intensity Interval Training During School Recess and Moderate-Intensity Continuous Training During School Recess in people with Classroom Attention-Related Behavior and School-Based Physical Activity, run by Shanghai University of Sport 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 8 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: finished, as of the sponsor's last update on 4 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Composite Observable Classroom Attention-Related Behavior Score (time frame: Baseline and immediately after the 6-week intervention at Week 8). 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 4 Sep 2026.