Clinical trial NCT03917316: Language Abilities of Children With ADHD
Official title: Language and Narrative Abilities of Children With ADHD and the Association to Executive Function, ADHD Symptoms and Social and Academic Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ADHD
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2019-04-17
Enrollment: 97
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: General language ability
timeFrame: One day
measure: Pragmatic language ability
timeFrame: One day
measure: Narrative abilities
timeFrame: One day
measure: Working memory 2back task
timeFrame: One day
measure: Working memory Mental Counters task
timeFrame: One day
measure: Working memory Tic Tac Toe task
timeFrame: One day
measure: Inhibition Stop-signal task
timeFrame: One day
measure: Inhibition Flanker task
timeFrame: One day
measure: Inhibition Go/No Go task
timeFrame: One day
measure: Social abilities
timeFrame: One day
measure: Academic abilities
timeFrame: One day
measure: Academic abilities teacher
timeFrame: One day
measure: Executive functions
timeFrame: One day
Secondary outcomes:
measure: Reaction time
timeFrame: One day
measure: General cognitive abilities
timeFrame: One day
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Psychology, Aarhus University
state: (non-US)
Study officials:
References:
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