NCT03917316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

3.7 years

First QC Date

April 4, 2019

Last Update Submit

May 6, 2022

Conditions

Outcome Measures

Primary Outcomes (13)

  • General language ability

    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.

    One day

  • Pragmatic language ability

    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.

    One day

  • Narrative abilities

    Online story-telling of the wordless picture book "Frog, where are you"

    One day

  • Working memory 2back task

    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.

    One day

  • Working memory Mental Counters task

    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.

    One day

  • Working memory Tic Tac Toe task

    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.

    One day

  • Inhibition Stop-signal task

    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.

    One day

  • Inhibition Flanker task

    Flanker task (Huyser et al., 2011), outcome median reaction time on conflict trials, with higher median reaction times indicating problems within inhibition.

    One day

  • Inhibition Go/No Go task

    Go/No go (Tsujimoto, 2006), outcome percent false alarms, higher percents indicating problems within inhibition.

    One day

  • Social abilities

    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.

    One day

  • Academic abilities

    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.

    One day

  • Academic abilities teacher

    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.

    One day

  • Executive functions

    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.

    One day

Secondary Outcomes (2)

  • Reaction time

    One day

  • General cognitive abilities

    One day

Study Arms (2)

ADHD

Other: Language and neuropsychological tests

Control

Other: Language and neuropsychological tests

Interventions

Tests related to language, narrative and specific and general cognitive function

ADHDControl

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychology, Aarhus University

Aarhus, (non-US), 8000, Denmark

Location

Related Publications (10)

  • Bellani M, Moretti A, Perlini C, Brambilla P. Language disturbances in ADHD. Epidemiol Psychiatr Sci. 2011 Dec;20(4):311-5. doi: 10.1017/s2045796011000527.

    PMID: 22201208BACKGROUND
  • Flory K, Milich R, Lorch EP, Hayden AN, Strange C, Welsh R. Online story comprehension among children with ADHD: which core deficits are involved? J Abnorm Child Psychol. 2006 Dec;34(6):853-65. doi: 10.1007/s10802-006-9070-7. Epub 2006 Oct 19.

    PMID: 17051434BACKGROUND
  • Jensen, K. d. L. (2011). Specifik sprogforstyrrelse - en komorbid forstyrrelse ved ADHD Best Practice, 14, 36-37.

    BACKGROUND
  • Korrel H, Mueller KL, Silk T, Anderson V, Sciberras E. Research Review: Language problems in children with Attention-Deficit Hyperactivity Disorder - a systematic meta-analytic review. J Child Psychol Psychiatry. 2017 Jun;58(6):640-654. doi: 10.1111/jcpp.12688. Epub 2017 Feb 10.

    PMID: 28186338BACKGROUND
  • Sciberras E, Mueller KL, Efron D, Bisset M, Anderson V, Schilpzand EJ, Jongeling B, Nicholson JM. Language problems in children with ADHD: a community-based study. Pediatrics. 2014 May;133(5):793-800. doi: 10.1542/peds.2013-3355.

    PMID: 24753530BACKGROUND
  • Gremillion ML, Martel MM. Semantic language as a mechanism explaining the association between ADHD symptoms and reading and mathematics underachievement. J Abnorm Child Psychol. 2012 Nov;40(8):1339-49. doi: 10.1007/s10802-012-9650-7.

    PMID: 22661106BACKGROUND
  • Lambek R, Tannock R, Dalsgaard S, Trillingsgaard A, Damm D, Thomsen PH. Executive dysfunction in school-age children with ADHD. J Atten Disord. 2011 Nov;15(8):646-55. doi: 10.1177/1087054710370935. Epub 2010 Sep 21.

    PMID: 20858784BACKGROUND
  • Purvis KL, Tannock R. Language abilities in children with attention deficit hyperactivity disorder, reading disabilities, and normal controls. J Abnorm Child Psychol. 1997 Apr;25(2):133-44. doi: 10.1023/a:1025731529006.

    PMID: 9109030BACKGROUND
  • Staikova E, Gomes H, Tartter V, McCabe A, Halperin JM. Pragmatic deficits and social impairment in children with ADHD. J Child Psychol Psychiatry. 2013 Dec;54(12):1275-83. doi: 10.1111/jcpp.12082. Epub 2013 May 18.

    PMID: 23682627BACKGROUND
  • Whitely C, Colozzo P. Who's Who? Memory updating and character reference in children's narratives. J Speech Lang Hear Res. 2013 Oct;56(5):1625-36. doi: 10.1044/1092-4388(2013/12-0176). Epub 2013 Jun 19.

    PMID: 23785191BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2019

First Posted

April 17, 2019

Study Start

May 1, 2018

Primary Completion

January 1, 2022

Study Completion

January 19, 2022

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations