NCT04639570

Brief Summary

The reported social benefits of knitting combined with the urgent need for social and activity-based programs in the disability community suggest that a knitting intervention may fill a substantial gap in available programs. Knitting may also be well suited to autistic strengths, combining sensory aspects (colourful sights, soft touch, rhythmic sounds), visual patterning, and repetitive actions. Surprisingly, no knitting programs for ASD or other conditions are reported in the literature. It is proposed that a knitting group can provide social and skill-building opportunities, improving real-world social outcomes for youth with ASD, and resulting in KneuroKnits, a program designed specifically to serve this need. The program will be designed and run by a collaborative team of clinicians, researchers, knitting experts, and a self-advocate with ASD. This program will enhance evidence supporting programs providing contexts for the dual goals of meaningful social interaction for young people with neurodevelopmental disorders, physical disabilities, and acquired brain injuries and building a real world creative skill that can facilitate social interaction within and beyond the program. This study will evaluate participants' experiences of the program as well as their levels of anxiety at various points during the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 3, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

3 months

First QC Date

November 2, 2020

Last Update Submit

November 19, 2020

Conditions

Outcome Measures

Primary Outcomes (8)

  • Self-reported Experience of Activity Settings (SEAS)

    The SEAS is a validated measure of participants' self-reports of their experiences of activity settings.

    End of first session (week 1)

  • Self-reported Experience of Activity Settings (SEAS)

    The SEAS is a validated measure of participants' self-reports of their experiences of activity settings.

    End of last session (week 4)

  • Symptom Checklist-90 (SCL-90; anxiety subscale; change during program participation)

    The SCL-90 has been used to evaluate anxiety in adults with ASD and is a broadly used measure in adults.

    Week 1

  • Symptom Checklist-90 (SCL-90; anxiety subscale; change during program participation)

    The SCL-90 has been used to evaluate anxiety in adults with ASD and is a broadly used measure in adults.

    Week 4

  • State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)

    Measure of current symptoms of anxiety.

    Beginning of Session 1 (week 1)

  • State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)

    Measure of current symptoms of anxiety.

    End of Session 1 (week 1)

  • State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)

    Measure of current symptoms of anxiety.

    Beginning of Session 4 (week 4)

  • State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)

    Measure of current symptoms of anxiety.

    End of Session 4 (week 4)

Study Arms (1)

KneuroKnits group

EXPERIMENTAL

Participants in the KneuroKnits group

Other: KneuroKnits

Interventions

The KneuroKnits program will be based upon current knitting education practices and leading practices in facilitation of social participation for individuals with neurodevelopmental disorders, physical disabilities, and acquired brain injuries. The program will consist of 4 weekly sessions in which participants will learn knitting fundamentals and have opportunities to socialize over a shared occupation. The 4 weekly sessions of the KneuroKnits curriculum will include related knitting and social skills themes of the week. Each session will begin with a structured lesson on the knitting topic of the day, and will then continue into knitting practice and social interaction. Participants will be encouraged to practice their new skills (knitting and social) between sessions, and will be allowed to keep all materials that they use or create.

KneuroKnits group

Eligibility Criteria

Age15 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • a confirmed diagnosis of a neurodevelopmental disorder, physical disability, and/or acquired brain injury;
  • no diagnosis of intellectual disability (IQ\>=70);
  • aged 15-24;
  • can understand and follow single- or multi-step instructions with or without assistance (determined by personal or parental report); and
  • can manipulate knitting materials (yarn, needles) as they are or with modifications and/or assistance. Indicators of ability will include tasks such as ability to tie a shoe or button shirt buttons.

You may not qualify if:

  • \) has engaged in self-harm or physical aggression in the past 6 months, due to safety risks with knitting needles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

Location

MeSH Terms

Conditions

Autism Spectrum DisorderNeurodevelopmental DisordersBrain Injuries

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Melanie Penner, MD

    Holland Bloorview Kids Rehabilitation Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 20, 2020

Study Start

November 3, 2018

Primary Completion

February 9, 2019

Study Completion

February 9, 2019

Last Updated

November 20, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Data may be shared upon reasonable request.

Locations