NCT04165655

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 10-week group based activity programme affects social skills and problem behaviours in CYP with ASC. It is hypothesised that children and young people (CYP) participating in the 10-week group based activity programme will show greater improvements in social skills and a greater reduction in problem behaviours than CYP not participating in the 10-week activity programme (control condition). Participants will be assigned to either the experimental condition (10-week activity programme) or waitlist control group. Participants in the 10-week activity programme will participate in group based activities including; 'pick up and play' sessions, swimming sessions and sport specific sessions coached by local sports teams. The 10-week activity programme consists of 1, 50 minute session per week for 10-weeks. Questionnaire data will be collected pre and post intervention to see if there are any differences in social skills and problem behaviour scores between the experimental and control group for 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 Feb 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

November 8, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

November 8, 2019

Last Update Submit

February 27, 2020

Conditions

Keywords

Autism spectrum conditionASCChildren and young peopleSocial skillsProblem behavioursActivity interventionWellbeingSelf imageSocial connectedness

Outcome Measures

Primary Outcomes (2)

  • Change in Social Skills Improvement System Rating Scales - Parent (Social Skills Improvement System; 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 with responses including; 0 'never' , 1 'seldom', 2 'often', and 3 '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". For the social skills domain higher scores indicate better outcomes. For the problem behaviours domain, higher scores indicate poorer outcomes.

    14 weeks

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

    The Social Skills Improvement System (SSIS) evaluates social skills and problem behaviours. Young people (8-12) indicate if a variety of different statements about problem behaviours or social skills are true of them on a 4-point scale: not true (minimum value), a little true, a lot true, and very true (maximum value). 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". For the social skills domain higher scores indicate better outcomes. For the problem behaviours domain, higher scores indicate poorer outcomes.

    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 (2)

Keep Achieving (KA) group

EXPERIMENTAL

Participants in the experimental group will take part in a 10-week group based activity programme. The activity programme will consist of 1, 50 minute session each week for the duration of 10-weeks. The activity sessions will include semi-structures free play sessions, sport specific sessions facilitated by local sports teams and swimming sessions.

Behavioral: Keep Achieving (KA)

Waitlist control group

NO INTERVENTION

Participants in this group will not receive the 10-week group based activity intervention throughout the duration of this study. Participants will be able to participate in the 10-week activity intervention once this research has ended.

Interventions

The 10-week group based activity programme will consist of 10 sessions each lasting 50 minutes.

Also known as: 10-week group based activity programme
Keep Achieving (KA) group

Eligibility Criteria

Age8 Years - 80 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 8-12 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 8-12 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 Hayes

Stafford, Staffordshire, ST16 3PG, United Kingdom

RECRUITING

Related Publications (11)

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

    BACKGROUND
  • 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

MeSH Terms

Conditions

Autism Spectrum DisorderSocial Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • James Smolinski

    Midlands Psychology CIC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study will use a between-subject design where by participants will be assigned to either the experimental (10-week programme) or waitlist control group. Participants will be assigned a group based in the area in which they live. As the 10-week programme will be running in Tamworth, those participants living in Tamworth and surrounds will be assigned to the experimental group. The participants living in Cannock and surrounds will be assigned to the waitlist control group and participate in a 10-week programme after this research.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 18, 2019

Study Start

February 1, 2020

Primary Completion

April 1, 2020

Study Completion

May 1, 2020

Last Updated

March 2, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations