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Language Abilities of Children With ADHD

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: NCT03917316
Recruitment Status : Enrolling by invitation
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

BACKGROUND: Attention-Deficit/Hyperactivity-Disorder (ADHD) is associated with language difficulties within expressive, receptive and pragmatic areas of language.Telling stories is a particularly interesting language task as is provides the possibility of investigating how children use their language in everyday interactions. Thus, investigating how children with ADHD tell stories provides a more naturalistic impression of their language abilities. However, the extent, causes, and clinical relevance of language and narrative difficulties in ADHD remain largely unknown. Language may be the key to understanding and improving the functional impairments associated with ADHD such as social and academic function.

AIM: The overall aim of the current study was to investigate the association between language, narrative ability and ADHD, what contributes to this association, as well as the clinical relevance of language difficulties in ADHD in relation to academic and social function.

METHOD: Children between 7-11 years old with ADHD will be recruited from Aarhus University Hospital in Skejby and compared to children without ADHD recruited from schools in the community. All children will be assessed at two separate meetings at the Department of Psychology, Aarhus University. The total number of participants in each group will depend on the intake of patients at Aarhus University Hospital, but a maximum of 100 children will be sampled in each group.


Condition or disease Intervention/treatment
ADHD Other: Language and neuropsychological tests

Detailed Description:

BACKGROUND:

Up to 40% of children with the ADHD are suggested to have language difficulties. Other than language difficulties being debilitating in their own right, language difficulties in childhood ADHD are problematic because they likely enhance the social and academic difficulties often present in children with this disorder. Children with ADHD also appear to have narrative difficulties; i.e. they have problems telling a coherent, understandable story. Telling stories is a particularly interesting language task as the investigation of how children use their language in an unstructured task is similar to how they use their language in everyday interactions.

However, the extent, causes, and clinical relevance of language and narrative difficulties in ADHD remain largely unknown. Studies are scarce and fraught with problems warranting investigations of language abilities in children with ADHD that measure language as well as executive function (EF) and that investigate the clinical relevance of these language difficulties. This is necessary in order to tease apart and gain knowledge of the association between language, EF and ADHD. Ultimately, such an investigation can inspire future assessment and treatment of language difficulties in children with ADHD.

AIMS AND HYPOTHESES

  1. The first aim is to examine narrative abilities in children with ADHD. This is done by investigating whether children with and without ADHD differ with respect to their narratives.
  2. The second aim is to examine whether language, EF and/or ADHD symptoms can explain narrative function in children with and without ADHD.
  3. The third aim is to investigate which specific domains of language children with ADHD have the most difficulty within.
  4. The fourth aim is to investigate whether the language difficulties as well as the narrative difficulties identified are associated with academic and social function in ADHD.

PARTICIPANTS AND PROCEDURES Up to 100 children with ADHD, age 7-11, consecutively referred from Aarhus University Hospital, Denmark, will be compared to up to 100 typically developing children, age 7-11, recruited from schools in the same community as the hospital.

After initial screening by telephone, informed consent has been obtained from both custodians and verbal assent has been given by the child, all children (ADHD and control) will be assessed at two separate meetings at the University of Aarhus by a member of the project group. The parents will receive questionnaires about their child and if the families give their consent, questionnaires will also be sent to the children's primary teacher. The parents and teachers receive questionnaires about the child's behavior, language and social and academic abilities.

All hypotheses will be investigated with appropriate statistical analyses. The role of IQ, parental educational level etc. is also examined in the analyses. If an adequate sample size is obtained, confirmatory factor analysis (CFA) will be applied to handle data, and if a factor solution is supported, factor scores will be included in all analyses, thereby reducing the number of variables in the analyses.

REGISTRATION DETAILS The study record reported at clinical trials.gov is completely consistent with the protocol approved by the Central Region Committee on Health Research Ethics in Denmark. The study was registered at clinical trials.gov after enrollment had begun, but no changes have been made in any procedures, recruitment etc., and as such it was assessed to be feasible to include the few participants that had been enrolled before registration in clinical trials.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Language and Narrative Abilities of Children With ADHD and the Association to Executive Function, ADHD Symptoms and Social and Academic Function
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2021

Group/Cohort Intervention/treatment
ADHD Other: Language and neuropsychological tests
Tests related to language, narrative and specific and general cognitive function

Control Other: Language and neuropsychological tests
Tests related to language, narrative and specific and general cognitive function




Primary Outcome Measures :
  1. General language ability [ Time Frame: One day ]
    Clinical Evaluation of Language Fundamentals-4 (Semel, Wiig & Secord, 2003), measures general language ability. Rawscores on the task are converted to scale scores with a range of 1-14. A scale score of 7-10 is average, above indicates better language proficiency.

  2. Pragmatic language ability [ Time Frame: One day ]
    Children's Communication Checklist-2 (CCC-2; Bishop, 2002), index for pragmatic ability, scaled scores (0-14), where 7-10 is average and above indicates better pragmatic language ability.

  3. Narrative abilities [ Time Frame: One day ]
    Online story-telling of the wordless picture book "Frog, where are you"

  4. Working memory 2back task [ Time Frame: One day ]
    A self-designed 2back task modelled from Friedman et al., 2008). Measures the child's working memory. Outcome is mean accuracy, range 0-1, with higher scores indicating better working memory.

  5. Working memory Mental Counters task [ Time Frame: One day ]
    Mental Counters (Huizinga et al., 2006). Measures the child's working memory. Outcome is mean accuracy, range 0-1, with higher scores indicating better working memory.

  6. Working memory Tic Tac Toe task [ Time Frame: One day ]
    Tic Tac Toe (Huizinga et al., 2006). Measures the child's working memory. Outcome is mean accuracy, range 0-1, with higher scores indicating better working memory.

  7. Inhibition Stop-signal task [ Time Frame: One day ]
    Stop-Signal task (Logan 1994; Logan, Schachar & Tannock, 1997; Williams, Pronesse, Schachar; Logan & Tannock, 1999); outcome Stop-signal Reaction time (SSRT), with slower reaction times indicating problems with inhibtion.

  8. Inhibition Flanker task [ Time Frame: One day ]
    Flanker task (Huyser et al., 2011), outcome median reaction time on conflict trials, with higher median reaction times indicating problems within inhibition.

  9. Inhibition Go/No Go task [ Time Frame: One day ]
    Go/No go (Tsujimoto, 2006), outcome percent false alarms, higher percents indicating problems within inhibition.

  10. Social abilities [ Time Frame: One day ]
    Social Competence Inventory-2 (Rydell Hagekull & Bohlin, 1997) a questionnaire about social competencies. The parents rate their child on a scale of 1-5 on 25 questions, higher scores indicate better social ability.

  11. Academic abilities [ Time Frame: One day ]
    5-15 questionnaire (Kadesjö, Janols, Korkman, Mickelsson, Strand, Trillingsgaard & Gillberg, 2005). Questions from the learning domain. The parent rates the child on a scale of 1-3 on 29 questions about academic ability, with higher scores indicating academic difficulties.

  12. Academic abilities teacher [ Time Frame: One day ]
    Teacher Telephone Interview (TTI, Tannock, Manassis & Fung, 2003, revised and translated with permission from R. Tannock). The teacher rates the child on a scale of 1-5 on 9 school subjects. Higher scores indicate better academic ability.

  13. Executive functions [ Time Frame: One day ]
    Childhood Executive Functioning inventory (CHEXI; Nyberg & Thorell, 2008). Questionnaire. The parent rates the child on a scale of 1-5 on 26 questions concerning the childs executive functioning. Higher scores indicate problems within executive functioning.


Secondary Outcome Measures :
  1. Reaction time [ Time Frame: One day ]
    Reaction time task (Tsujimoto, 2006) measures the child's average reaction time, with higher scores indicating faster reaction time.

  2. General cognitive abilities [ Time Frame: One day ]
    Ravens Coloured Matrices (Raven, 1998). A task that measures the child's general cognitive ability on a scale of 0-36, where higher scores indicate better cognitive abilities.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The clinical group of children with ADHD will be recruited from the Aarhus University Hospital and the typical developing control group will be recruited from schools in the community.
Criteria

Inclusion criteria

  • Age between 7 and 11 years.
  • For the clinical group: Current ADHD diagnosis (Development and Well-Being Assessment; DAWBA, Goodman et al., 2000).

Exclusion criteria:

  • Autism spectrum diagnosis (ASD) based on the Development and Well-Being Assessment (DAWBA, Goodman et al., 2000) or a history of ASD based on parent report on a background questionnaire.
  • Epilepsy or known brain damage based on parent report (background questionnaire).
  • IQ < 70 based on an intelligence test.
  • Danish as a second language, based on parent report (background questionnaire).
  • Low birth weight (<1500 grams) based on parent report (background questionnaire).
  • Premature birth (before 32nd gestation week) based on parent report (background questionnaire).
  • Use of medication that is expected to affect cognition (background questionnaire).
  • Impaired sight, hearing, or motor function (as this would interfere with task performance), based on parent report (background questionnaire).
  • For the control group: Current (based on the DAWBA) or previous (based on parent- reports from the background questionnaire) ADHD diagnosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917316


Locations
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Denmark
Department of Psychology, Aarhus University
Aarhus, (non-US), Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Publications:
Jensen, K. d. L. (2011). Specifik sprogforstyrrelse - en komorbid forstyrrelse ved ADHD Best Practice, 14, 36-37.

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03917316    
Other Study ID Numbers: Language and ADHD
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No