Systematic Aerobics and Intelligent Monitoring System in Executive Skill Training for School-aged Children With ADHD

NCT05668195 | Unknown

• 1 other identifier: AEIMS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Around 7.2% of children around the world are suffering from Attention Deficit Hyperactivity Disorder (ADHD). Systematic executive skill training for children is currently recognized as one of the main programs for psychosocial behavioral interventions in ADHD, but the theoretical basis for the 1 hour "play class" component of the 3 hours per week children's classroom is insufficient. We have developed a closed-loop moderate-intensity aerobic training system, which is combined with an intelligent monitoring system, to further standardize and improve the treatment and management of ADHD intervention. The intelligent monitoring system in this study includes physiological intelligent monitoring (heart rate data) and psychological and behavioral intelligent monitoring (based on the computerized "adaptive" executive function testing procedures and clinical questionnaire scale). 200 subjects aged 6-12 years with a diagnosis of ADHD based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria are randomly assigned into two groups to receive executive skill training and systematic aerobic exercise and intelligent monitoring system, or systematic executive skill training for 13 weeks. Symptoms severity is assessed by Vanderbilt Assessment Scales at weeks 0, 6, and 13. Subjects' executive function is assessed using executive function tests before and after training, parental depression/anxiety assessment, family environment assessment, and monitoring of heart rate during exercise are also included. All the other sociodemographic data are assessed. This study will investigate the effects of systematic aerobic exercise and intelligent monitoring system in executive skill training on the promotion of cold executive functions such as responsiveness, flexibility, and inhibition and hot executive functions such as reward mechanisms in children, and their effects on children with ADHD and their families.

Conditions

ADHD

Keywords

ADHD, Executive Skill Training, Aerobic Exercise

Outcome Measures

Primary Outcomes (9)

• The changes in ADHD clinical symptoms-Estimated by Chinese version of Vanderbilt parent/teacher diagnostic scale

  The Vanderbilt parent/teacher diagnostic scale is designed to measure the severity of ADHD symptoms for children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 49-56/36-43 are performance measures. The symptom measures in the scale, scored 0 to 3. A positive response in symptom assessment part is a 2 or 3 (often, very often). The performance measures in the scale, scored 1 to 5, with 4 and 5 being somewhat of a problem/problematic. The scoring standard: Must score a 2 or 3 on 6 out of 9 items on questions 1-9(Predominantly Inattentive subtype)/10-18(Predominantly Hyperactive/Impulsive subtype)/both 1-9 and 10-18(ADHD Combined Inattention/Hyperactivity) AND Score a 4 or 5 on any of the Performance questions 49-56(parent)/36-43(teacher). The higher scores mean a worse outcome.

  at weeks 0 for the children with first diagnosis of ADHD

• The changes in ADHD clinical symptoms-Estimated by Chinese version of Vanderbilt parent/teacher follow-up scale

  The Vanderbilt parent/teacher follow-up scale is designed to track treatment effect over time for ADHD children aged 6 to 12. It has 2 components: symptom assessment and impairment in performance. The symptom assessment screens for symptoms relevant to inattentive (items 1-9) and hyperactive (items 10-18) ADHD. The items 19-26 are performance measures. The symptom measures in the scale, scored 0 to 3 (Never, Occasionally, Often, Very Often). The performance measures in the scale, scored 1 to 5 (Excellent, Above Average, Average, Somewhat of a Problem, Performance Problematic). The scoring standard: 1) Calculate Total Symptom Score for questions 1-18. 2) Calculate Average Performance Score for questions 19-26. The higher scores mean a worse outcome.

  at weeks 0, 6 and 13

• False alarms of GO/NO-GO task

  GO/NO-GO task reflects response inhibition. Subjects are required to press a button when a certain stimulus appeared on the screen (e.g., a circle) and not when some other stimulus appeared (e.g., a triangle), with the majority of stimuli requiring a button (≥75%) and a small percentage of stimuli not requiring a button (≤25%). The false alarms are the numbers of stimuli to which subjects responded incorrectly that did not require a response.

  at weeks 0 and 13

• The correct rate of GO/NO-GO task

  GO/NO-GO task reflects response inhibition. Subjects are required to press a button when a certain stimulus appeared on the screen (e.g., a circle) and not when some other stimulus appeared (e.g., a triangle), with the majority of stimuli requiring a button (≥75%) and a small percentage of stimuli not requiring a button (≤25%). We will calculate the correct rate.

  at weeks 0 and 13

• The correct rate of Stop-signal task

  Similar to GO/NO-GO task, Stop-signal task also reflects response inhibition. The "GO" signal presents every time, but in a few instances the "GO" signal is followed by a "Stop" signal, when the subject was asked not to press the button. The majority of stimuli (≥75%) require to press a button, while the "GO" signal followed by a "Stop" signal is ≤25%. We will calculate the correct rate.

  at weeks 0 and 13

• The correct rate of Simon task

  Simon task reflects interference control. When subjects see stimulus A, press the left button (L); when they see stimulus B, press the right button (R). Stimuli A and B may appear in different directions. We will calculate the correct rate.

  at weeks 0 and 13

• The number of correct switches of DCCS task

  DCCS task reflects cognitive flexibility. Subjects are presented with a set of stimulus pictures with different dimensions (such as shape, number and color) and test pictures that can be matched with different stimulus pictures in different dimensions. Subjects need to classify the current stimulus according to different rules. When the rules change, they need to adjust their reactions as soon as possible and change the classification way. The number of correct switches refers to the number of times the subject continuously makes the correct response when the classification rule is changed.

  at weeks 0 and 13

• The correct rate of DCCS task

  DCCS task reflects cognitive flexibility. Subjects are presented with a set of stimulus pictures with different dimensions (such as shape, number and color) and test pictures that can be matched with different stimulus pictures in different dimensions. Subjects need to classify the current stimulus according to different rules. When the rules change, they need to adjust their reactions as soon as possible and change the classification way. We will calculate the correct rate.

  at weeks 0 and 13

• The hit rate and the false alarm rate of N-back task

  N-back task reflects working memory. The subjects are presented with a series of stimuli and asked to compare the current stimulus with the Nth stimulus backwards. If the two stimuli are the same, it is the target; if they are different, it is the non-target. The hit rate means that the subject responds correctly to the target, and the false alarm rate means that the subject responds incorrectly to the non-target.

  at weeks 0 and 13

Secondary Outcomes (4)

• The changes of parental mood-Estimated by Self-rating depression scale (SDS)

  at weeks 0, 6 and 13

• The changes of parental mood-Estimated by Self-rating anxiety scale (SAS)

  at weeks 0, 6 and 13

• The changes of family environment-Estimated by Family environment scale-Chinese version (FES-CV)

  at weeks 0, 6 and 13

• The changes in heart rate

  during the class of aerobic exercise, about 40min per class, once a week, 13weeks

Study Arms (2)

aerobic exercise group

EXPERIMENTAL

The patients aged 6-12 with a diagnose of ADHD of this group receive systematic aerobic exercise and intelligent monitoring system in executive skill training for 13 weeks, including those taking methylphenidate or not.

Procedure: systematic aerobic exercise and intelligent monitoring system in executive skill training; Procedure: executive skill training

executive skill training group

ACTIVE COMPARATOR

The patients aged 6-12 with a diagnose of ADHD of this group receive executive skill training for 13 weeks, including those taking methylphenidate or not.

Procedure: executive skill training

Interventions

systematic aerobic exercise and intelligent monitoring system in executive skill training PROCEDURE

This is a closed-loop training initially developed by the research team in conjunction with other teams, adding a systematic aerobic exercise and intelligent monitoring system to the typical executive skill training, and is being further explored in training.

aerobic exercise group

executive skill training PROCEDURE

The training program, based on Dawson and Guare's (2010) training of executive skills for children, aimed to improve the everyday performance of executive skills among children with ADHD. Qian Y and her team added some culturally adapted information, following the theory of cognitive behavioral therapy, to ensure that the concepts were acceptable to Chinese children.

aerobic exercise group; executive skill training group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnose of ADHD according to DSM-5
• Aged 6-12 years
• Children receiving methylphenidate are required to be titrated to a stable dose before training, and those who did not change medication, stop medication, or adjust dose during training are included in the analysis

You may not qualify if:

• IQ≤80
• Inconsistent or changing dose of methylphenidate during the participation period
• Suffering from organic lesions of nervous system now or in the past
• Suffering from epilepsy, autism spectrum disorder and other severe neurodevelopmental behavioral disorders now or in the past
• Not suitable for medium to high intensity aerobic training

Sponsors & Collaborators

• Chen Li: lead
• Southwest University, China: collaborator

Study Sites (1)

Growth, Development and Mental health of Children and Adolescence Center

Chongqing, Chongqing Municipality, 400014, China

RECRUITING

Related Publications (6)

• Wolraich ML, Hagan JF Jr, Allan C, Chan E, Davison D, Earls M, Evans SW, Flinn SK, Froehlich T, Frost J, Holbrook JR, Lehmann CU, Lessin HR, Okechukwu K, Pierce KL, Winner JD, Zurhellen W; SUBCOMMITTEE ON CHILDREN AND ADOLESCENTS WITH ATTENTION-DEFICIT/HYPERACTIVE DISORDER. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2019 Oct;144(4):e20192528. doi: 10.1542/peds.2019-2528.

  PMID: 31570648 BACKGROUND

• Brown TE. ADD/ADHD and Impaired Executive Function in Clinical Practice. Curr Psychiatry Rep. 2008 Oct;10(5):407-11. doi: 10.1007/s11920-008-0065-7.

  PMID: 18803914 BACKGROUND

• Brown TE, Holdnack J, Saylor K, Adler L, Spencer T, Williams DW, Padival AK, Schuh K, Trzepacz PT, Kelsey D. Effect of atomoxetine on executive function impairments in adults with ADHD. J Atten Disord. 2011 Feb;15(2):130-8. doi: 10.1177/1087054709356165. Epub 2009 Dec 21.

  PMID: 20026871 BACKGROUND

• Qian Y, Chen M, Shuai L, Cao QJ, Yang L, Wang YF. Effect of an Ecological Executive Skill Training Program for School-aged Children with Attention Deficit Hyperactivity Disorder: A Randomized Controlled Clinical Trial. Chin Med J (Engl). 2017 Jul 5;130(13):1513-1520. doi: 10.4103/0366-6999.208236.

  PMID: 28639564 BACKGROUND

• Diamond A, Lee K. Interventions shown to aid executive function development in children 4 to 12 years old. Science. 2011 Aug 19;333(6045):959-64. doi: 10.1126/science.1204529.

  PMID: 21852486 BACKGROUND

• Liang X, Li R, Wong SHS, Sum RKW, Sit CHP. The impact of exercise interventions concerning executive functions of children and adolescents with attention-deficit/hyperactive disorder: a systematic review and meta-analysis. Int J Behav Nutr Phys Act. 2021 May 22;18(1):68. doi: 10.1186/s12966-021-01135-6.

  PMID: 34022908 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Li Chen, doctor

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

• yu T Li, MS

  Children's Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Li Chen, doctor

CONTACT

136 7762 0103; chenli2012@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor, Director

Model Details: The children in the group are randomly divided into a test group and a control group, and further divided into 4 groups according to whether they were also treated with medication (methylphenidate) or not. Children receiving methylphenidate are required to be titrated to a stable dose before training, and those who did not change medication, stop medication, or adjust dose during training are included in the analysis. The test group receive systematic aerobic exercise and intelligent monitoring system in executive skill training, the control group receive systematic executive skill training, for 13 weeks. The research team, together with other teams, has initially developed a set of closed-loop training and is further exploring it in training.

Study Record Dates

• First Submitted: December 9, 2022
• First Posted: December 29, 2022
• Study Start: May 24, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)