Evaluation of Benign Joint Hypermobility and Serum Prolidase Levels in Children Diagnosed With Attention-Deficit/Hyperactivity Disorder (ADHD) Compared to Healthy Controls

NCT07663383 | Completed DMC

• 1 other identifier: 130220253/2
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional observational study investigates the clinical and biochemical relationship between Attention-Deficit/Hyperactivity Disorder (ADHD) and Benign Joint Hypermobility Syndrome (BJHS) in pediatric patients. The primary objective is to evaluate the prevalence of BJHS in children diagnosed with ADHD and compare serum prolidase levels with those of healthy controls. The study also explores whether the severity of ADHD symptoms correlates with serum prolidase activity. Clinical assessments include the Conners Parent Rating Scale, Beighton Score, and serum prolidase measurement using ELISA. This research aims to provide new insights into the potential connective tissue-neurodevelopmental link and contribute to early screening frameworks for children with ADHD.

Conditions

ADHD; Benign Joint Hypermobility Syndrome; ADHD - Attention Deficit Disorder With Hyperactivity; ADHD - Combined Type; ADHD - Inattentive Type

Keywords

adhd; bjhs; joint hypermobility; beighton score; prolidase

Outcome Measures

Primary Outcomes (1)

• Incidence of comorbid Benign Joint Hypermobility Syndrome (BJHS) in children with ADHD

  The primary outcome is to evaluate the incidence of Benign Joint Hypermobility Syndrome (BJHS) among children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), compared to healthy controls. Diagnosis of BJHS will be based on a Beighton score ≥5 and clinical evaluation.

  At enrollment (single visit)

Secondary Outcomes (3)

• Beighton Score for Joint Hypermobility

  At enrollment (single visit)

• Serum Prolidase Level

  At enrollment (single visit)

• Sociodemographic Characteristics

  At enrollment

Study Arms (2)

Group 1 Name: ADHD Group Type: Observational Cohort

Children aged 6 to 12 years who were clinically diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) according to DSM-5 criteria. Participants in this cohort were recruited from the Child and Adolescent Psychiatry outpatient clinic of Antalya Training and Research Hospital. Each child underwent a detailed clinical evaluation including the Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S) to determine ADHD symptom severity and subtype. Joint hypermobility was assessed using the Beighton Score, and venous blood samples were collected to measure serum prolidase enzyme activity using ELISA. No therapeutic intervention was applied; this is a non-interventional observational group.

Group 2 Name: Control Group Type: Observational Cohort

This group consisted of age- and sex-matched healthy children between 6 and 12 years of age with no history of psychiatric, neurological, or systemic illness. Control participants were selected from the general pediatric outpatient population and underwent the same evaluations as the ADHD group. These included the Conners' Parent Rating Scale-Revised: Short Form (CPRS-R:S), Beighton Score assessment for joint hypermobility, and serum prolidase measurement via ELISA. The purpose of this group was to provide a baseline comparison for clinical and biochemical parameters without any intervention applied.

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of children aged 6 to 12 years, including 86 patients diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) according to DSM-5 criteria and 85 age- and sex-matched healthy controls. Patients were recruited from the Child and Adolescent Psychiatry outpatient clinic of Antalya Training and Research Hospital. Control subjects were selected from the general pediatric outpatient department. All participants were evaluated for ADHD symptom severity, joint hypermobility, and serum prolidase levels.

You may qualify if:

• Children aged between 6 and 12 years
• ADHD diagnosis based on DSM-5 criteria (for patient group)
• Healthy children with no known psychiatric or systemic disease (for control group)
• Willingness of the parents or legal guardians to participate and provide informed consent
• Ability to complete the required clinical assessments (CPRS-R:S, Beighton Score, blood sample)

You may not qualify if:

• Presence of chronic systemic diseases (e.g., autoimmune disorders, connective tissue diseases, metabolic syndromes)
• History of neurodegenerative or severe neurological disorders Intellectual disability or autism spectrum disorder diagnosis
• Use of medications that may affect prolidase enzyme activity (e.g., corticosteroids, immunosuppressants)
• Any orthopedic or musculoskeletal condition interfering with Beighton assessment
• Incomplete clinical or laboratory data
• Refusal to participate or lack of parental consent

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital

Antalya, Muratpaşa, 07100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Joint Instability

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: June 23, 2026
• Study Start: April 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 11, 2025
• Last Updated: June 23, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD and supporting documents will be available upon reasonable request after publication of study results. Requests can be submitted via email to the principal investigator. All shared data will be de-identified.
• Access Criteria: Qualified researchers affiliated with academic or research institutions may request access to de-identified individual participant data (IPD) and supporting documents (e.g., study protocol, statistical analysis plan) by contacting the principal investigator via email. All requests will be reviewed and must include a data use agreement. Data will be provided electronically under secure conditions, only for non-commercial scientific purposes.

Locations

TU (1)