NCT04288986

Brief Summary

Participation in structured activities and physical activity (PA) have been linked to several indicators of positive development such as self-esteem and psychological health as well as greater academic outcomes and lower school drop-out rates. Despite this, 77% of boys and 80% of girls aged 5-15 in the UK also fall below the national physical activity guidelines of 60 minutes of moderate to vigorous activity per day. Children with Autism Spectrum Conditions (ASC) may be at particular risk for inactivity as they are more likely to experience barriers to participation in these types of activities and motor skills impairments, common in people with ASC, can further limit participation in PA. Studies that have attempted to increase PA in young people with autism have shown reduction in problem behaviours such as inattention and aggression and increase in positive behaviours such as sleep, improvements in quality of life, academic performance and physical competence, and reductions in stress. The primary research aim is to investigate whether participation in a 8-week group based activity programme affects social skills and problem behaviours in CYP with ASC.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

March 15, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

10 months

First QC Date

February 26, 2020

Last Update Submit

February 26, 2020

Conditions

Keywords

Autism spectrum conditionAutismSportWellbeingSelf-image

Outcome Measures

Primary Outcomes (2)

  • Social Skills Improvement System Rating Scales - Parent (SSIS; Gresham & Elliott (2007).

    The Social Skills Improvement System (SSIS) evaluates social skills and problem behaviours. Parents/guardians report on the frequency their children exhibit social skills and problem behaviours on a 4-point scale: never, seldom, often, and almost always. Social skills are evaluated in the following domains: communication, cooperation, assertion, responsibility, empathy, engagement, and self-control. Problem behaviours assessed include: externalizing, bullying, hyperactivity/inattention, internalising, and "autism spectrum".

    14 weeks

  • Social Skills Improvement System Rating Scales - Child (SSIS; Gresham & Elliott (2007).

    The Social Skills Improvement System (SSIS) evaluates social skills and problem behaviours. Young people (8-18) indicate if a variety of different statements about problem behaviours or social skills are true of them on a 4-point scale: not true, a little true, a lot true, and very true. Social skills are evaluated in the following domains: communication, cooperation, assertion, responsibility, empathy, engagement, and self-control. Problem behaviours assessed include: externalizing, bullying, hyperactivity/inattention, internalising, and "autism spectrum".

    14 weeks

Secondary Outcomes (4)

  • Social Connectedness Scale Revised (SCS-R; Lee, Draper & Lee 2001)

    14 weeks

  • Self Image Profile (SIP; Butler)

    14 weeks

  • The Short Warwick-Edinburgh Mental Wellbeing Scales (SWEMWBS; Stewart-Brown et al., 2009)

    14 weeks

  • Goal Based Outcomes (GBOs)

    14 weeks

Study Arms (1)

Keep Achieving (KA) group

EXPERIMENTAL

Participants in the experimental group will take part in a 8-week group based activity programme. The activity programme will consist of 1, 50 minute session each week for the duration of 8-weeks. The activity sessions will include semi-structured free play sessions, sport specific sessions facilitated by local sports teams and swimming sessions.

Behavioral: Keep Achieving

Interventions

Keep AchievingBEHAVIORAL

The 8-week group based activity programme will consist of 8 sessions each lasting 50 minutes.

Also known as: 8-week group based activity programme
Keep Achieving (KA) group

Eligibility Criteria

Age5 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • A child or young person with a working or full diagnosis of an Autism spectrum condition (ASC). Parents/carers will be asked to provide proof in the form of a letter that their child has an ASC.
  • The child with an ASC must be between the ages of 5-15 years. All participants must confirm they are physically fit to participate in this research as some activities involve moderate to vigorous physical activity.
  • All children with an ASC who are receiving alternative support are required to declare this prior to participation and specify the type of support received.

You may not qualify if:

  • Children/young people without a full or working ASC diagnosis Children with a full or working diagnosis of ASC not between the ages of 5-15 years People who are not deemed physically fit to participate in the activity programme by their own self-assessment.
  • Current or recent participation in another clinical trial/study/scientific experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hates

Stafford, Staffs, ST16 3PG, United Kingdom

Location

Related Publications (11)

  • Eccles, J. S., & Barber, B. L. (1999). Student council, volunteering, basketball, or marching band what kind of extracurricular involvement matters? Journal of adolescent research, 14(1), 10-43.

    BACKGROUND
  • Hastings RP, Kovshoff H, Ward NJ, degli Espinosa F, Brown T, Remington B. Systems analysis of stress and positive perceptions in mothers and fathers of pre-school children with autism. J Autism Dev Disord. 2005 Oct;35(5):635-44. doi: 10.1007/s10803-005-0007-8.

    PMID: 16177837BACKGROUND
  • Kohl HW 3rd, Hobbs KE. Development of physical activity behaviors among children and adolescents. Pediatrics. 1998 Mar;101(3 Pt 2):549-54.

    PMID: 12224661BACKGROUND
  • Lang, R., Koegel, L. K., Ashbaugh, K. et al. (2010). Physical exercise and individuals with autism spectrum disorders: A systematic review. Research in Autism Spectrum Disorders, 4(4), 565-576.

    BACKGROUND
  • Lee, R. M., Draper, M., & Lee, S. (2001). Social connectedness, dysfunctional interpersonal behaviors, and psychological distress: Testing a mediator model. Journal of counseling psychology, 48(3), 310.

    BACKGROUND
  • Neff, K. D., & Faso, D. J. (2015). Self-compassion and well-being in parents of children with autism. Mindfulness, 6(4), 938-947.

    BACKGROUND
  • Memari, A. H., Kordi, R., Ziaee, V. (2012). Weight status in Iranian children with autism spectrum disorders: Investigation of underweight, overweight and obesity. Research in Autism Spectrum Disorders, 6(1), 234-239.

    BACKGROUND
  • Public Health England (2016). Health matters: getting every adult active every day. [online] Available at: https://www.gov.uk/government/publications/health-matters-getting-every-adult-active-every-day/health-matters-getting-every-adult-active-every-day [Accessed 20 Aug. 2019].

    BACKGROUND
  • Stewart-Brown S, Tennant A, Tennant R, Platt S, Parkinson J, Weich S. Internal construct validity of the Warwick-Edinburgh Mental Well-being Scale (WEMWBS): a Rasch analysis using data from the Scottish Health Education Population Survey. Health Qual Life Outcomes. 2009 Feb 19;7:15. doi: 10.1186/1477-7525-7-15.

    PMID: 19228398BACKGROUND
  • Trost SG, Kerr LM, Ward DS, Pate RR. Physical activity and determinants of physical activity in obese and non-obese children. Int J Obes Relat Metab Disord. 2001 Jun;25(6):822-9. doi: 10.1038/sj.ijo.0801621.

    PMID: 11439296BACKGROUND
  • Butler R.J. (2001) The self-image profile for children (SIP-C) and adolescents (SIP-A). Manual. London, The Psychological Corporation

    RESULT

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • James Smolinski, MSc

    james.smolinski@midlandspsychology.co.uk

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: The study will use a pretest-posttest quasi experimental design. Participants will complete a serious of questionnaires prior to participating in an 8 week activity programme and again after completing the programme.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2020

First Posted

February 28, 2020

Study Start

March 15, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations