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ADHDNCT02898532

Children With ADHD and ADHD-like Symptoms and Target Shooting Sport in Danish Shooting Associations.

A study testing Educational programmes in people with ADHD, run by University of Southern Denmark at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Practising target shooting sport requires focused attention and motoric steadiness. Parental reports suggest that children with attention-deficit/hyperactivity disorder (ADHD) benefit from participating in target shooting sport in Danish Shooting Associations. Read more about this study

Who is it for?
Ages 10 to 14 years
Conditions the study is for
ADHD
What is being tested?
Educational programmes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
1 siteDenmark
Study dates
Jan 2016to Dec 2018
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 10 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children following criteria: Age 10-14 years, either ADHD diagnosis or selected by school staff or school psychologist to show distinct difficulties with inattention, hyperactivity and impulsivity, which affects the child's school attendance. If the child receives pharmacological treatment for ADHD and the treatment is expected to be stable during the intervention period.

Who cannot join

  • Children showing a physical visual handicap or severe symptoms of current mental health difficulties such as psychosis or suicidal ideations or impulses are not included.

Trial locations and contacts

1 site in 1 country.

Annegrete Månsson, Ph.D.fellow contact

+45 6550 2057

amaansson@health.sdu.dk

Mette Elmose, MSc, Ph.D., contact

+45 6550 4625

melandersen@health.sdu.dk

Denmark1 site, 1 recruiting
  • Odense kommune

    Odense, Region Syddanmark, 5000

    Annegrete Maansson, Ph.d. fellow, +45 23 69 53 38, amaansson@health.sdu.dk

    Recruiting

Other trials in Denmark

About this study

Official title: The Influence of Participating in Target Shooting Sport on Inattentive, Hyperactive and Impulsive Symptoms in Children - A Controlled Study of Best Practice.

Practising target shooting sport requires focused attention and motoric steadiness. Parental reports suggest that children with attention-deficit/hyperactivity disorder (ADHD) benefit from participating in target shooting sport in Danish Shooting Associations.

Aim: This study aims at examining if and to which extent target shooting sport in children with attention difficulties reduces parent- and teacher-reported severity of inattentiveness, hyperactivity, and impulsivity, and improves the children's well-being and quality of life.

Read the detailed description

Children with Attention Deficit Hyperactivity Disorder (ADHD) (DSM-5) are characterised by three core symptoms: inattention, hyperactivity and impulsivity. Approximately 2-3 % of Danish school children are diagnosed with ADHD (Madsen, Ersbøll, Olsen, Parner, \& Obel, 2015), and the prevalence in Denmark is about 5 % (Dalsgaard, Nielsen, \& Simonsen, 2013). Many children with ADHD experience difficulties in managing social relations, e.g. team sports, and are often excluded from leisure activities with other children. This can have an impact on their well-being and quality of life which to a high degree depend on whether they have friends and communities with peers (Riley et al., 2006). Almost 50 % of children with ADHD experience the core symptoms in adulthood, and many develop psychological and social problems (Dalsgaard, Mortensen, Frydenberg, \& Thomsen, 2013) and are at risk of premature death (Dalsgaard, Ostergaard, Leckman, Mortensen, \& Pedersen, 2015). The NICE guideline (National Collaborating Centre for Mental Health, 2009) recommends a combination of pharmacological and psychosocial treatment (multimodal treatment approach) for children aged 6-18 years, to remedy other symptoms than ADHD core symptoms. A growing focus on the benefits of sports activities, yoga and mindfulness suggests that physical activity may have a positive impact on children and young people with ADHD (Cerrillo-Urbina et al., 2015; Kang, Choi, Kang, \& Han, 2011; Haydicky, Wiener, Badali, Milligan , \& Ducharme, 2012; van der Oord, Bogels, \& Peijnenburg, 2012; van de Weijer-Bergsma, Formsma, de Bruin, \& Bogels, 2012).

The sport of Target shooting can be regarded as a type of mental training in which the athlete uses techniques breathing to calm down, focus and improve attention. Mind and body must be in complete balance and the techniques used are similar to those used in meditation (Jeppesen \& Pensgaard, 2006). Furthermore, regulations apply to the Danish Shooting Associations, in combination with the way the target shooting sport is practiced in Denmark is associated with fixed physical boundaries, clear rules and a distinct structure for the activity. Furthermore, it is a sport where the adult instructor always is very close to the child, and it is custom for the instructor gives instructions in a calm, structured and concise manner. Thus, target-shooting sport has implicitly features elements that can be considered protective environmental factors for the inattentive child and thus may contribute to reduce ADHD-symptoms and strengthen the child's well-being and quality of life. In 2012, the Danish Gymnastics and Sporting Organization (DGI) initiated a sports project, where children with ADHD or similar symptoms of inattention, hyperactivity and impulsivity practiced target-shooting sport in Danish Shooting Association. The evaluation showed, that the children became more concentrated and focussed during the training (Maansson, 2015). Based on this experience, this study has been initiated. However no studies have investigated the effect of target shooting sports for children with difficulties with inattention, hyperactivity and impulsivity.

The main aim of this study is therefore to investigate the influence of participation in target shooting sports in Danish Shooting Association for children having difficulties with inattention, hyperactivity and impulsivity.

Conditions
ADHD
Being tested
Educational programmes
Keywords
Children, ADHD, target shooting sport
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.

  • Educational programmesBehavioural

    Children with ADHD or ADHD-like symptoms practicing target shooting sport in Danish Shooting Associations, during schooltime, for 6 months.

Study groups in NCT02898532
Study groupRoleWhat they receive
Intervention groupActive comparatorThe intervention is organised in collaboration between the local school, the Danish Shooting Association, and the national DGI (The Danish Gymnastics and Sporting Organization). The intervention is available geographical nationwide. The children will practise target-shooting sport in local Shooting Association once a week during school hours for a period of 6 months. Selected schools are either special schools or municipal schools with special educational programmes for children diagnosed with either ADHD or severe difficulties of hyperactivity, inattention and impulsivity. Teachers accompany the children to the Shooting Association where the instructors meet them.
Receives: Behavioral: Educational programmes
Control groupNo interventionThe same target group as children in the intervention group. In the control group children are not practicing target shooting sport, neither in school or free time.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Teacher-rated ADHD-RS-IV.

    The total score on the relevant 18 items on symptoms of inattention, hyperactivity and impulsivity on the teacher-rated ADHD-RS-IV.

    Measured: Pre- and post (6 months after commencement) intervention

Secondary outcomes (6)
  1. Qb-test.

    Hyperactivity (distance and area) and inattention (reaction time variance and omission errors) as measured by the Qb-test.

    Measured: Pre- and post (6 months after commencement) intervention

  2. Parent-rated ADHD-RS-IV.

    The total score on the relevant 18 items on symptoms of inattention, hyperactivity and impulsivity on the parent-rated ADHD-RS-IV.

    Measured: Pre- and post (6 months after commencement) intervention

  3. Teacher- and parent-rated SDQ.

    The total scores on the teacher- and parent-rated SDQ.

    Measured: Pre- and post (6 months after commencement) intervention

  4. Child-rated Kidscreen-27

    Quality of life as measured by the total score on the child-rated Kidscreen-27.

    Measured: Pre- and post (6 months after commencement) intervention

  5. Interviews

    Semistructured qualitative Interviews with parents, teachers and children. Focus on children's participation and engagement and mechanisms of change.

    Measured: Prior to intervention (1 month) start, during intervention period (6 months) and after end of intervention (1-3 months). A total period of 8-10 months.

  6. Observations

    Observations of children (interventions group) in classroom and in the Shooting Association. Focus on participation and engagement.

    Measured: Prior to intervention (1 month) start, during intervention period (6 months) and after end of intervention (1-3 months). A total period of 8-10 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

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
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02898532
Sponsor's protocol ID
SDU-SUN-VEK20130134
Status last verified
Sep 2016
First submitted
8 Sep 2016
Last updated
15 Sep 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Mansson AG, Elmose M, Dalsgaard S, Roessler KK. The influence of participation in target-shooting sport for children with inattentive, hyperactive and impulsive symptoms - A controlled study of best practice. BMC Psychiatry. 2017 Mar 28;17(1):115. doi: 10.1186/s12888-017-1283-5.

    PubMed 28351351

Questions about this trial

What is this clinical trial studying?

A study testing Educational programmes in people with ADHD, run by University of Southern Denmark 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Sep 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Annegrete Månsson, Ph.D.fellow (+45 6550 2057, amaansson@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Teacher-rated ADHD-RS-IV. (time frame: Pre- and post (6 months after commencement) intervention). 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 NCT02898532, which also lists 1 linked publication.

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 15 Sep 2016.

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