ADHDNCT03917316
Language Abilities of Children With ADHD
An observational study of ADHD, run by University of Aarhus at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- What is being tested?
- Language and neuropsychological tests
- How many people
- 97 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2018to 19 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Age between 7 and 11 years.
- For the clinical group: Current ADHD diagnosis (Development and Well-Being Assessment; DAWBA, Goodman et al., 2000).
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Psychology, Aarhus University
Aarhus, (non-US), 8000
About this study
Official title: Language and Narrative Abilities of Children With ADHD and the Association to Executive Function, ADHD Symptoms and Social and Academic Function
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.
Read the 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
- 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.
- The second aim is to examine whether language, EF and/or ADHD symptoms can explain narrative function in children with and without ADHD.
- The third aim is to investigate which specific domains of language children with ADHD have the most difficulty within.
- 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.
- Conditions
- ADHD
- Being tested
- Language and neuropsychological tests
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language and neuropsychological testsOther
Tests related to language, narrative and specific and general cognitive function
| Study group | Role | What they receive |
|---|---|---|
| ADHD | Not described Receives: Other: Language and neuropsychological tests | |
| Control | Not described Receives: Other: Language and neuropsychological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: One day
Narrative abilities
Online story-telling of the wordless picture book "Frog, where are you"
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One day
Inhibition Go/No Go task
Go/No go (Tsujimoto, 2006), outcome percent false alarms, higher percents indicating problems within inhibition.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One day
Secondary outcomes (2)
Reaction time
Reaction time task (Tsujimoto, 2006) measures the child's average reaction time, with higher scores indicating faster reaction time.
Measured: One day
General cognitive abilities
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 May 2018
- Primary completion1 Jan 2022
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917316
- Sponsor's protocol ID
- Language and ADHD
- Status last verified
- May 2022
- First submitted
- 4 Apr 2019
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22201208Flory 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.
PubMed 17051434Jensen, K. d. L. (2011). Specifik sprogforstyrrelse - en komorbid forstyrrelse ved ADHD Best Practice, 14, 36-37.
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.
PubMed 28186338Sciberras 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.
PubMed 24753530Gremillion 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.
PubMed 22661106Lambek 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.
PubMed 20858784Purvis 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.
PubMed 9109030Staikova 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.
PubMed 23682627Whitely 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.
PubMed 23785191
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Language and Narrative Abilities of Children With ADHD and the Association to Executive Function, ADHD Symptoms and Social and Academic Function
- ClinicalTrials.gov ID
- NCT03917316
- Acronym / sponsor ID
- Language and ADHD
- Conditions
- ADHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 May 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- 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.
- The second aim is to examine whether language, EF and/or ADHD symptoms can explain narrative function in children with and without ADHD.
- The third aim is to investigate which specific domains of language children with ADHD have the most difficulty within.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD | – | Other: Language and neuropsychological tests |
| Control | – | Other: Language and neuropsychological tests |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- Age between 7 and 11 years.
- For the clinical group: Current ADHD diagnosis (Development and Well-Being Assessment; DAWBA, Goodman et al., 2000).
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Language and neuropsychological testsTests related to language, narrative and specific and general cognitive function | Other | ADHD, Control |
Primary outcome
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.
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.
Narrative abilities
Time frame: One day
Online story-telling of the wordless picture book "Frog, where are you"
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.
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.
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.
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.
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.
Inhibition Go/No Go task
Time frame: One day
Go/No go (Tsujimoto, 2006), outcome percent false alarms, higher percents indicating problems within inhibition.
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.
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.
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.
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.
2 secondary outcomes
Reaction time
Time frame: One day
General cognitive abilities
Time frame: One day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Background: PubMed 22201208Bellani M, Moretti A, Perlini C, Brambilla P. Language disturbances in ADHD. Epidemiol Psychiatr Sci. 2011 Dec;20(4):311-5. doi: 10.1017/s2045796011000527.
- Background: PubMed 17051434Flory 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.
- BackgroundJensen, K. d. L. (2011). Specifik sprogforstyrrelse - en komorbid forstyrrelse ved ADHD Best Practice, 14, 36-37.
- Background: PubMed 28186338Korrel 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.
- Background: PubMed 24753530Sciberras 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.
- Background: PubMed 22661106Gremillion 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.
- Background: PubMed 20858784Lambek 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.
- Background: PubMed 9109030Purvis 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.
- Background: PubMed 23682627Staikova 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.
- Background: PubMed 23785191Whitely 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General language ability (time frame: One day). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917316, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.