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Prevalence of Autistic Spectrum Disorder (ASD) in Children With Haemophilia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05138224
Recruitment Status : Completed
First Posted : November 30, 2021
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary:

Parents of children with haemophilia will be invited to complete 3 questionnaires to look for traits present in ASD. With consent teacher will complete a further 2 questionnaires. If all 3 questionnaires are above threshold, then with consent of the family the child will be referred for further investigation.

There are already pre-existing children with ASD who will be exempt from the study, but included in the data analysis of prevalence.

The results of the 3 questionnaires will be used to identify a profile of social communication in children with haemophilia.


Condition or disease
Haemophilia Autism Spectrum Disorder Social Communication Disorder Attention Deficit Hyperactivity Disorder

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 82 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is There a Higher Prevalence of Autistic Spectrum Disorder (ASD) in Children With Haemophilia (Aged 5-16) Than the General Population?
Study Start Date : September 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : December 2019





Primary Outcome Measures :
  1. Prevalence of autism spectrum disorder in boys with haemophilia at Great Ormond St Hospital [ Time Frame: Within 2 weeks of when the participant consented- measured once ]
    The number of children with a diagnosis of ASD at GOSH


Secondary Outcome Measures :
  1. Social Communication Questionnaire [ Time Frame: Within 2 weeks of when the participant consented-measured once ]
    Questionnaire Scores > or equal to 15 will be considered positive

  2. Childrens communication Checklist [ Time Frame: Within 2 weeks of when the participant consented-measured once ]
    Questionnaire Scores < or equal to 132 will be considered positive

  3. BRIEF [ Time Frame: Within 2 weeks of when the participant consented-measured once ]
    Questionnaire Scores on the global executive composite score of > or equal to 65 will be considered positive

  4. Number of children being given a diagnosis of ASD or other following referral for ongoing assessment following positive scores on questionnaires [ Time Frame: From when study started October 2014 to study end July 2017 ]
    Children gaining above threshold on the SCQ, CCC and BRIEF and with consent of the family will be referred locally, assessed and the number of children gaining an additional diagnosis will be recorded



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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   All boys with haemophilia at Great Ormond St Hospital haemophilia centre
Sampling Method:   Non-Probability Sample
Study Population
All boys with all severities of haemophilia aged 5-16 years
Criteria

Inclusion Criteria:

-All boys with mild, moderate or severe haemophilia will be offered to participate in the questionnaire completion

Exclusion Criteria:

-boys with a pre-existing diagnosis of ASD will be excluded from questionnaire completion but will be included in the prevalence analysis

Publications:
World Health Organization. The ICD-10 Classification of Mental and Behavioural Disorders: Diagnostic Criteria for Research. WHO, 1993.
Rutter, M., Bailey, A. & Lord,C. (2003) Social Communication Questionnaire (SCQ).Western Psychological Services.
Gioia, G.A., Isquith, P.K., Guy, S.C., Kenworthy, L. (2000) Behaviour rating inventory of executive functioning Florida: Psychological Assessment Resources Inc.
Bishop DVM. (2003) Children's Communication Checklist Version 2 (CCC2). Psychological Corporation.

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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05138224    
Other Study ID Numbers: 10MH17
First Posted: November 30, 2021    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Communication Disorders
Hemophilia A
Disease
Attention Deficit Disorder with Hyperactivity
Autism Spectrum Disorder
Social Communication Disorder
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Child Development Disorders, Pervasive
Neurobehavioral Manifestations