The Therapeutic Effect of Methylphenidate Hydrochloride in Conjunction with Sensory Integration Training in Children with Attention Deficit Hyperactivity Disorder.

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Background:

Attention deficit hyperactivity disorder (ADHD) is a prevalent childhood disorder with existing treatment challenges, and research on the combined therapy of methylphenidate hydrochloride and sensory integration training for it is inconclusive. Thus, this study explored the clinical efficacy of this combined treatment in children with ADHD, finding it significantly improved relevant scores and reduced adverse reactions, suggesting its potential for wider use.

Methods:

From June 2022 to June 2023, a research sample of 102 individuals diagnosed with ADHD was recruited and allocated into 2 groups at an observation group (n=52) and a control group (n=50). Exclusively methylphenidate hydrochloride extended-release tablets were given to the control group as treatment, whereas the observation group underwent combined therapy with methylphenidate hydrochloride extended-release tablets and sensory integration training. The assessment and comparison of sensory integration and praxis tests, full-scale response control quotient, full-scale attention quotient, Conners’ behavior rating scale, and adverse reactions during the treatment period were conducted prior to and following 2 treatment cycles in both the observation and control groups.

Results:

Prior to treatment, there were no remarkable variations (P > .05) in the scores of sensory integration and praxis tests, Integrated Visual and Auditory Continuous Performance Test (IVA-CPT) scores, and behavior rating scale between the 2 groups. Following the treatment, the observation group exhibited notably superior scores in the sensory integration and praxis test, IVA-CPT, and behavior rating scale, with a notably reduced occurrence of complications, in comparison to the control group (P < .05).

Conclusion:

To summarize, the utilization of methylphenidate hydrochloride alongside sensory integration training has demonstrated promising effectiveness in treating children diagnosed with ADHD and deserves broader implementation.

INTRODUCTION

Attention Deficit Hyperactivity Disorder (ADHD), a prevalent disorder in childhood, is characterized by symptoms of inattention, hyperactivity, and impulsivity.1,2 According to literature reports, the prevalence of ADHD during school age ranges from 2% to 18%, with a male-to-female ratio of 4:1 to 9:1, and approximately 70% of ADHD patients also have comorbid sensory integration dysfunction (SID).3 In addition to placing burdens on families and society,4 this neurodevelopmental disorder has a negative impact on individuals’ abilities in learning, socialization, and emotional regulation.

Pharmacotherapy and behavioral therapy are the mainstays of conventional treatment methods for children with ADHD.5,6 Methylphenidate hydrochloride, a frequently prescribed medication for ADHD, works by regulating dopamine and norepinephrine levels in the brain, leading to enhanced neural regulatory functions in children.7 However, relying solely on medication may not fully cater to the requirements of children with ADHD, and prolonged medication usage can entail specific side effects and dependency risks. In recent years, sensory integration training has been widely employed as a non-pharmacological intervention for children with neurodevelopmental disorders.8,9,10 Sensory integration training is a method that stimulates and integrates children’s sensory systems to improve motor control and attention. This type of training can involve exercises that focus on balance, tactile stimulation, body awareness, and motor control, aiming to enhance children’s perceptual and cognitive abilities.11

The combination of methylphenidate hydrochloride and sensory integration training is expected to be superior to single-modality treatment for several reasons. From a mechanistic perspective, methylphenidate hydrochloride targets neurotransmitter imbalances in the brain, primarily enhancing attention and reducing hyperactive and impulsive behaviors. On the other hand, sensory integration training addresses the underlying sensory processing deficits commonly associated with ADHD.

For example, a study by Bluschke12 found that children with ADHD often have abnormal sensory processing in areas such as the tactile, vestibular, and proprioceptive systems. By integrating sensory input through training, it can help improve overall neural plasticity and functional connectivity in the brain, which may complement the effects of methylphenidate hydrochloride.

Moreover, previous research has also provided preliminary evidence for the effectiveness of combined approaches. Schulze13 conducted a small-scale study on a similar patient population and found that the group receiving combined treatment showed greater improvement in behavioral symptoms and cognitive function compared to those receiving only medication. However, due to the limited sample size and methodological differences in these previous studies, the results were inconclusive.

Despite this, the existing research on the therapeutic effects of methylphenidate hydrochloride in combination with sensory integration training for ADHD is still lacking and yields inconclusive results. Hence, it becomes imperative to undertake this study in order to assess the therapeutic effects of combining methylphenidate hydrochloride with sensory integration training in treating children with ADHD. Through the analysis of changes in indicators such as attention, hyperactive behavior, and cognitive function pre- and post-treatment, more dependable evidence can be offered for clinical practice, facilitating improved recovery and development in children with ADHD.

MATERIAL AND METHODS

General Information

In the timeframe of June 2022 to June 2023, a total of 102 children diagnosed with ADHD from the Zhejiang Rehabilitation Hospital were allocated into 2 groups according to the different treatments they received: an observation group (n=52) and a control group (n=50). In the control group, there were 29 males and 21 females, ranging in age from 6 to 13 years, with an average age of (9.0 ± 1.3) years. The duration of the disorder spanned from 13 to 65 months, with an average duration of (39.2 ± 1.9) months.

Comprising 32 males and 20 females, the observation group had an age range of 6 to 12 years, with an average age of (8.9 ± 1.3) years. The disorder’s duration ranged from 14 to 66 months, with an average duration of (39.6 ± 1.6) months. The inclusion criteria were as follows: (1) presence of SID; (2) informed consent from guardians and voluntary participation.

The exclusion criteria were as follows: (1) epilepsy; (2) mental disorders; (3) intellectual development delay; (4) use of monoamine oxidase inhibitors in the past 2 weeks; (5) drug intolerance or allergies; (6) organic brain abnormalities. Basic medical history data showed no substantial variations between the 2 groups, and the P-value exceeded .05.

Methods

Control group (Methylphenidate Hydrochloride Extended-Release Tablet treatment only): Methylphenidate Hydrochloride Extended-Release Tablets (Approval Number: Registration Certificate H20170264; Drug Specification: 18 mg × 15 tablets) were taken in the morning (do not chew or break the tablets). The initial dose was 1 tablet per time, once daily, and the dose was adjusted weekly based on individual circumstances, with a maximum daily dose of 3 tablets. Additionally, liver function, blood pressure, and body weight were monitored every 2-4 weeks.

Observation group (Methylphenidate Hydrochloride Extended-Release Tablet and Sensory Integration Training treatment): Methylphenidate Hydrochloride Extended-Release Tablets were used in the same manner as the control group. In addition, Sensory Integration Training was performed as follows: (1) SID was assessed using the Pediatric Sensory Integration Abilities Scale. The degree of impairment was classified as severe (≤19 points), moderate (20-29 points), mild (30-39 points), or normal (≥40 points).

(2) Training preparation: ① Based on the children’s treatment needs and characteristics, a Sensory Integration Training room was designed. For example, in terms of environmental colors, a combination of dynamic and static patterns and warm and cool tones were used to create a pleasant and harmonious atmosphere. ② The child was first familiarized with the environment through happy and simple games to stimulate their interest, eliminate tension, gain the child’s trust, and then relevant training was conducted.

(3) Training content: Training was tailored according to the degree and type of SID. For example, for children with tactile dysfunction, activities involving a large cage ball pressure on the body, soft cushions, tactile balls, and sand were selected. For children with proprioceptive dysfunction or vestibular imbalance, activities such as balancing beams, jumping beds, kangaroo hops, skateboarding, and balance beams were selected.

Maze walking and assembling items were also included to improve hand-eye coordination and visual integration. (4) Training duration: Following the principles of combining dynamic and static movements, starting with simple exercises and gradually progressing to more complex ones, each training session lasted 90-100 minutes, with a frequency of 4 times per week. A total of 20 sessions constituted 1 treatment course, and 2 treatment courses were conducted.

This study was conducted in compliance with ethical standards and was approved by the Ethics Committee of Zhejiang Rehabilitation Hospital (Approval Number: 2022-006; Date: June 18, 2022). Informed consent was obtained from the patients’ families and legal guardians.

Observation Indicators

Before treatment and after 2 treatment courses (about 10 weeks), the following scales were used to evaluate the children with ADHD in both groups: (1) SIS;14 (2) Integrated Visual and Auditory Continuous Performance Test (IVA-CPT),15 which recorded the scores of the Full-Scale Response Control Quotient (FRCQ) and the Full-Scale Attention Quotient (FAQ); (3) Behavior Rating Scale,16 which utilized the Children and Adolescent Psychological Evaluation Software (Shanghai Huicheng Company) with a parent questionnaire including 48 items covering learning problems, conduct problems, emotional problems, impulsivity, hyperactivity index, and anxiety. Lower scores indicate better outcomes; (4) The occurrence of adverse reactions during the treatment period in both groups was recorded.

Statistical Methods

SPSS 25.0 (IBM SPSS Corp.; Armonk, NY, USA) was employed to perform the statistical analysis in this research. Means and standard deviations will be reported for continuous variables and analyzed through t-tests, while frequencies and percentages [n (%)] will be used to represent categorical variables and assessed using chi-square tests. The significance level of P < .05 will be applied to determine statistical significance.

RESULTS

Pediatric Sensory Integration Abilities Scale Scores

In the pre-treatment phase, there were no noteworthy differences in the Supports Intensity Scale (SIS) scores (consisting of “tactile defensiveness,” “vestibular imbalance,” “proprioceptive dysfunction,” and “underdeveloped learning abilities”) between the 2 groups, with a P-value exceeding .05. Subsequently, after treatment, the scores significantly improved in both groups. Additionally, the observation group achieved superior scores in all aspects compared to the control group, with a P-value lower than .05 (Table 1).

Integrated Visual and Auditory Continuous Performance Test Scores

In the pre-treatment phase, there were no notable variations in IVA-CPT scores (FAQ and FRCQ) between the 2 groups, with a P-value greater than .05. Subsequently, after treatment, substantial improvement in scores was observed in both groups. Additionally, the observation group outperformed the control group, attaining higher scores, as indicated in Table 2, with a P-value less than .05 (Table 2).

Behavior Rating Scale Scores

Prior to treatment, no substantial difference was observed in behavior rating scale scores between the 2 groups, with a P-value greater than .05. Following treatment, scores decreased in both groups relative to the pre-treatment stage, and the contrast between the 2 groups exhibited statistical significance, with a P-value less than .05 (Table 3).

Adverse Reactions

The observation group exhibited a lower incidence of adverse reactions at 11.54%, which was statistically remarkable compared to the control group’s 28.00%, with a P-value below .05 (Table 4).

DISCUSSION

While numerous clinical treatment options exist for children with ADHD, it is essential to personalize interventions to meet each child’s unique condition and consider their family circumstances. Pharmacotherapy, being one of the conventional treatment methods for ADHD, has limitations as it mainly provides short-term and partial alleviation of clinical symptoms, potentially inadequate in addressing the adverse effects of the disorder on the child’s psychosocial well-being.17

This research aimed to examine the therapeutic impact of integrating methylphenidate hydrochloride with sensory integration training in children presenting ADHD symptoms. The present study involved the allocation of 102 children with ADHD to either the observation group or the control group. Specifically, the observation group underwent a treatment protocol that integrated the use of methylphenidate hydrochloride and sensory integration training, while the control group exclusively received extended-release tablets of methylphenidate hydrochloride.

The effectiveness was assessed by comparing different assessment measures prior to and following the treatment. The outcomes revealed that there were no significant differences (P > .05) in the SIS scores, IVA-CPT scores, and behavior rating scale scores between the 2 groups before treatment, indicating similar baseline levels of sensory integration abilities, attention, and behavior problems. Nevertheless, following treatment, the observation group exhibited remarkably elevated scores in SIS, IVA-CPT, and Conner’s Behavior Rating Scale in comparison to the control group, displaying statistically notable discrepancies (P < .05).

The outcomes indicate that the utilization of a combination approach involving methylphenidate hydrochloride and sensory integration training can effectively boost sensory integration abilities, attention, and behavioral challenges in children diagnosed with ADHD. Additionally, the incidence of adverse reactions in the observation group was significantly lower than in the control group, indicating that this combined treatment approach can reduce the occurrence of adverse reactions during the treatment period, providing a safer and more acceptable treatment option for children with ADHD.

In a nutshell, the outcomes of this study are consistent with prior research, affirming the therapeutic advantages of integrating methylphenidate hydrochloride with sensory integration training for children diagnosed with ADHD. The study by Gao et al18 found that methylphenidate hydrochloride combined with sensory integration training can effectively control the symptoms of children with ADHD and has a good safety profile. This treatment approach combines pharmacotherapy with sensory training, considering the pathological and physiological mechanisms involved, thereby enhancing treatment outcomes.

Methylphenidate hydrochloride medication improves attention and hyperactive behavior, while sensory integration training stimulates and integrates sensory systems to enhance perceptual and cognitive abilities, as well as motor control and attention. Therefore, combining these approaches comprehensively improves the overall symptoms of children with ADHD.

The combination of methylphenidate hydrochloride and sensory integration training shows advantages in treating children with ADHD. The combined treatment may have fewer adverse reactions. On one hand, sensory integration training improves children’s nervous system function and self-regulation ability, reducing the body’s stress response to drugs and the occurrence probability of adverse reactions.

For example, it enhances proprioception and balance, maintaining internal environment stability and reducing adverse reactions like dizziness and nausea. On the other hand, methylphenidate acts by regulating dopamine and norepinephrine levels. Sensory integration training may optimize the brain’s utilization efficiency of these neurotransmitters, reducing the drug dose requirement and the risk of adverse reactions from high doses.

At the same time, it has a positive impact on children’s psychological state, reducing psychological stress and related adverse reactions. In conclusion, this combination shows good efficacy and should be widely promoted in clinical practice as it provides a comprehensive and personalized treatment choice for children with ADHD.

Nonetheless, this study has certain limitations. The small sample size and short observation period affect the universality of the results of this study. The small sample size makes it difficult to cover the differences among children from different regions and backgrounds, potentially missing differences in effects and reducing the applicability of the results.

The short observation period makes it impossible to know the long-term treatment effect and new changes, making it is difficult to reflect the real situation of combined treatment in long-term practice. In future studies, multi-center cooperation could be carried out to expand the sample size and ensure sample diversity. Long-term follow-up studies can be carried out to pay attention to long-term indicators such as growth, development, and academic achievement.

These studies could explore the best treatment plans at different stages to provide a more reliable basis for clinical practice.

In summary, the integration of methylphenidate hydrochloride and sensory integration training has exhibited favorable efficacy in enhancing sensory integration abilities, attention, and behavioral challenges in children with ADHD. The widespread promotion of this treatment approach in clinical practice is imperative, as it offers an all-encompassing and individualized treatment choice for children with ADHD, ultimately improving their recovery and overall quality of life.

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