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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02898532
Other study ID # SDU-SUN-VEK20130134
Secondary ID
Status Recruiting
Phase N/A
First received September 8, 2016
Last updated September 14, 2016
Start date January 2016
Est. completion date December 2018

Study information

Verified date September 2016
Source University of Southern Denmark
Contact Annegrete Månsson, Ph.D.fellow
Phone +45 6550 2057
Email amaansson@health.sdu.dk
Is FDA regulated No
Health authority Denmark: The National Committee on Health Research Ethics
Study type Interventional

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 98
Est. completion date December 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 14 Years
Eligibility Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Denmark Odense kommune Odense Region Syddanmark

Sponsors (1)

Lead Sponsor Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Pre- and post (6 months after commencement) intervention No
Secondary Qb-test. Hyperactivity (distance and area) and inattention (reaction time variance and omission errors) as measured by the Qb-test. Pre- and post (6 months after commencement) intervention No
Secondary 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. Pre- and post (6 months after commencement) intervention No
Secondary Teacher- and parent-rated SDQ. The total scores on the teacher- and parent-rated SDQ. Pre- and post (6 months after commencement) intervention No
Secondary Child-rated Kidscreen-27 Quality of life as measured by the total score on the child-rated Kidscreen-27. Pre- and post (6 months after commencement) intervention No
Secondary Interviews Semistructured qualitative Interviews with parents, teachers and children. Focus on children's participation and engagement and mechanisms of change. 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. No
Secondary Observations Observations of children (interventions group) in classroom and in the Shooting Association. Focus on participation and engagement. 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. No
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