Attention Deficit Hyperactivity DisorderNCT02516917
The Feasibility of a Brief Attention Training Technique in Improving Behaviour and Attention in Children With ADHD
A study testing Attention Training Technique in people with Attention Deficit Hyperactivity Disorder, run by University of Manchester at 1 site in United Kingdom.
Trial summary
This study aims to investigate the application of the Attention Training Technique in children with ADHD aged 7-11 years old. The research aims to investigate both the feasibility of this technique in this population as well as whether it can improve symptoms, behaviour and executive functioning. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Attention Training Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to May 2016
- Phase
- Interventional
- 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
- No healthy volunteers
- Child
Who may be able to join
- Children with a formal diagnosis of ADHD as given by a psychiatrist or community paediatrician
- Children between the ages of 7 and 11. This age group was selected as previous research on attention training in this population has used this age group
- Children who are currently on a waiting list at a Child and Adolescent Mental Health Service (CAMHS) or a child psychology service, or being seen by a CAMHS or psychology service for medication review only
- Children who speak fluent English which will ensure they are able to comprehend the tasks instructions adequately.
Who cannot join
- Children who are not stabilised on stimulant medication and/or willing to maintain their medication type/dose
- Children with a major neurological illness or acquired central nervous system injury
- Children who at the point of referral have a co-existing diagnosis of an Autistic Spectrum Disorder
- Children who are currently in receipt of another non-pharmacological intervention for ADHD or who are currently taking part in another research trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility of a Brief Attention Training Technique for Improving Behaviour and Attention in Children With ADHD
This study aims to investigate the application of the Attention Training Technique in children with ADHD aged 7-11 years old. The research aims to investigate both the feasibility of this technique in this population as well as whether it can improve symptoms, behaviour and executive functioning.
Read the detailed description
Attention deficit hyperactivity disorder (ADHD) is a neurobehavioural disorder characterised by core symptoms of hyperactivity, impulsivity and inattention. Its prevalence ranges between 3-9% of school-aged children, making it one of the most common presentations in child and adolescent mental health services.
In the last 10 years, research into the effectiveness of attention training as an intervention for children with ADHD has been increasing. This has tended to follow assumptions that children with the disorder either lack skills in focusing and maintaining their attention and/or have neurological deficits in areas responsible for attention functions. Results have been encouraging, with study participants demonstrating improvements in symptoms and behaviour following a course of attention training. However, the method and length of training has varied across studies.
This study aims to investigate a treatment called the Attention Training Technique (ATT) that approaches attention difficulties in this disorder from a different perspective. Instead of viewing inattention as a result of structural or skills deficits, it posits that children with ADHD have these skills, but are perhaps unaware of the flexibility and control they have over them. This treatment aims to increase this awareness and subsequently improve ratings of attention, behaviour and other areas of executive functioning.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Attention Training Technique
- 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.
Attention Training TechniqueBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Attention Training Technique (ATT) | Experimental | Participants will receive 3-5 sessions of the ATT over a period of 3-5 weeks. A set of standardised instructions will be read to each participant and then they will engage in the procedure for a period of 12 minutes. Participants will listen to a set of auditory stimuli and follow the directions of the recording. This will ask them to focus their attention on selected sounds or spatial locations, switch attention between different sounds and locations, before allocating their attention to all sounds simultaneously. Participants will be given a recording of the ATT on a C.D and asked to practice this at least once before the second session. Receives: Behavioral: Attention Training Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inattention on the Swanson, Nolan and Pelham questionnaire (Snap-IV)
Parent's rating of their child's inattentiveness
Measured: Change from baseline in attention post treatment and at follow up 6 weeks later
Secondary outcomes (8)
Hyperactivity on the Swanson, Nolan and Pelham questionnaire (Snap-IV)
Parent's rating of their child's hyperactivity
Measured: Change from baseline in hyperactivity post treatment and at follow up 6 weeks later
Impulsivity on the Swanson, Nolan and Pelham questionnaire (Snap-IV)
Parent's rating of their child's impulsivity
Measured: Change from baseline in impulsivity post treatment and at follow up 6 weeks later
Attentional control on the Attentional Control Scale for Children (ASC-C)
Children's self reported ability to focus and shift their attention
Measured: Change from baseline in attentional control post treatment and at follow up 6 weeks later
Behaviour on the Strengths and Difficulties Questionnaire (SDQ)
Parent's ratings of their child's behaviours
Measured: Change from baseline in behaviour post treatment and at follow up 6 weeks later
Executive functioning on The Behavioural Rating Inventory of Executive Functioning (BRIEF)
Parent's ratings of their child's executive functioning behaviours in the home environment
Measured: Change from baseline in executive functioning post treatment and at follow up 6 weeks later
Working memory on the Weschler Intelligence Scale for Children (WISC-IV) - Digit Span
Children's Working memory as assessed by the Digit Span subtest
Measured: Change from baseline in working memory post treatment and at follow up 6 weeks later
Working memory on the Weschler Intelligence Scale for Children (WISC-IV) - Letter Number Sequencing
Children's Working memory as assessed by the Letter Number Sequencing subtest
Measured: Change from baseline in working memory post treatment and at follow up 6 weeks later
Treatment Acceptability Questionnaire
Parents rating of the acceptability of the treatment
Measured: Rated once at the final session of treatment, 4 weeks after the 2nd baseline is taken
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrian Wells, University of Manchester
- Investigators
- Adrian Wells, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516917
- Sponsor's protocol ID
- 163562
- Status last verified
- Oct 2016
- First submitted
- 31 Jul 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of a Brief Attention Training Technique for Improving Behaviour and Attention in Children With ADHD
- ClinicalTrials.gov ID
- NCT02516917
- Acronym / sponsor ID
- 163562
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Aug 2015 (estimated)
- 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.
This study aims to investigate the application of the Attention Training Technique in children with ADHD aged 7-11 years old. The research aims to investigate both the feasibility of this technique in this population as well as whether it can improve symptoms, behaviour and executive functioning.
Detailed description
Attention deficit hyperactivity disorder (ADHD) is a neurobehavioural disorder characterised by core symptoms of hyperactivity, impulsivity and inattention. Its prevalence ranges between 3-9% of school-aged children, making it one of the most common presentations in child and adolescent mental health services.
In the last 10 years, research into the effectiveness of attention training as an intervention for children with ADHD has been increasing. This has tended to follow assumptions that children with the disorder either lack skills in focusing and maintaining their attention and/or have neurological deficits in areas responsible for attention functions. Results have been encouraging, with study participants demonstrating improvements in symptoms and behaviour following a course of attention training. However, the method and length of training has varied across studies.
This study aims to investigate a treatment called the Attention Training Technique (ATT) that approaches attention difficulties in this disorder from a different perspective. Instead of viewing inattention as a result of structural or skills deficits, it posits that children with ADHD have these skills, but are perhaps unaware of the flexibility and control they have over them. This treatment aims to increase this awareness and subsequently improve ratings of attention, behaviour and other areas of executive functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Attention Training Technique (ATT) | Experimental | Behavioral: Attention Training TechniqueParticipants will receive 3-5 sessions of the ATT over a period of 3-5 weeks. A set of standardised instructions will be read to each participant and then they will engage in the procedure for a period of 12 minutes. Participants will listen to a set of auditory stimuli and follow the directions of the recording. This will ask them to focus their attention on selected sounds or spatial locations, switch attention between different sounds and locations, before allocating their attention to all sounds simultaneously. Participants will be given a recording of the ATT on a C.D and asked to practice this at least once before the second session. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with a formal diagnosis of ADHD as given by a psychiatrist or community paediatrician
- Children between the ages of 7 and 11. This age group was selected as previous research on attention training in this population has used this age group
- Children who are currently on a waiting list at a Child and Adolescent Mental Health Service (CAMHS) or a child psychology service, or being seen by a CAMHS or psychology service for medication review only
- Children who speak fluent English which will ensure they are able to comprehend the tasks instructions adequately.
Key exclusion criteria (4 listed)
- Children who are not stabilised on stimulant medication and/or willing to maintain their medication type/dose
- Children with a major neurological illness or acquired central nervous system injury
- Children who at the point of referral have a co-existing diagnosis of an Autistic Spectrum Disorder
- Children who are currently in receipt of another non-pharmacological intervention for ADHD or who are currently taking part in another research trial
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 |
|---|---|---|
| Attention Training Technique | Behavioural | Attention Training Technique (ATT) |
Primary outcome
Inattention on the Swanson, Nolan and Pelham questionnaire (Snap-IV)
Time frame: Change from baseline in attention post treatment and at follow up 6 weeks later
Parent's rating of their child's inattentiveness
8 secondary outcomes
Hyperactivity on the Swanson, Nolan and Pelham questionnaire (Snap-IV)
Time frame: Change from baseline in hyperactivity post treatment and at follow up 6 weeks later
Impulsivity on the Swanson, Nolan and Pelham questionnaire (Snap-IV)
Time frame: Change from baseline in impulsivity post treatment and at follow up 6 weeks later
Attentional control on the Attentional Control Scale for Children (ASC-C)
Time frame: Change from baseline in attentional control post treatment and at follow up 6 weeks later
Behaviour on the Strengths and Difficulties Questionnaire (SDQ)
Time frame: Change from baseline in behaviour post treatment and at follow up 6 weeks later
Executive functioning on The Behavioural Rating Inventory of Executive Functioning (BRIEF)
Time frame: Change from baseline in executive functioning post treatment and at follow up 6 weeks later
Working memory on the Weschler Intelligence Scale for Children (WISC-IV) - Digit Span
Time frame: Change from baseline in working memory post treatment and at follow up 6 weeks later
Working memory on the Weschler Intelligence Scale for Children (WISC-IV) - Letter Number Sequencing
Time frame: Change from baseline in working memory post treatment and at follow up 6 weeks later
Treatment Acceptability Questionnaire
Time frame: Rated once at the final session of treatment, 4 weeks after the 2nd baseline is taken
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 25 Oct 2016.
- 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.
Adrian Wells principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Training Technique in people with Attention Deficit Hyperactivity Disorder, run by University of Manchester at 1 site in United Kingdom.
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 4 inclusion and 4 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 25 Oct 2016. 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 United Kingdom. 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?
Inattention on the Swanson, Nolan and Pelham questionnaire (Snap-IV) (time frame: Change from baseline in attention post treatment and at follow up 6 weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2016.