KneuroKnits: Participation and Anxiety in People With Neurological Conditions Participating in a Knitting Group
Primary Purpose
Autism Spectrum Disorder, Neurodevelopmental Disorders, Acquired Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
KneuroKnits
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
1) has engaged in self-harm or physical aggression in the past 6 months, due to safety risks with knitting needles
Sites / Locations
- Holland Bloorview Kids Rehabilitation Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KneuroKnits group
Arm Description
Participants in the KneuroKnits group
Outcomes
Primary Outcome Measures
Self-reported Experience of Activity Settings (SEAS)
The SEAS is a validated measure of participants' self-reports of their experiences of activity settings.
Self-reported Experience of Activity Settings (SEAS)
The SEAS is a validated measure of participants' self-reports of their experiences of activity settings.
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.
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.
State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)
Measure of current symptoms of anxiety.
State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)
Measure of current symptoms of anxiety.
State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)
Measure of current symptoms of anxiety.
State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)
Measure of current symptoms of anxiety.
Secondary Outcome Measures
Full Information
NCT ID
NCT04639570
First Posted
November 2, 2020
Last Updated
November 19, 2020
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04639570
Brief Title
KneuroKnits: Participation and Anxiety in People With Neurological Conditions Participating in a Knitting Group
Official Title
KneuroKnits: Evaluating Social Participation and Anxiety Response Associated With Participation in a Knitting Group for People With Neurological Conditions (Pilot Study)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
November 3, 2018 (Actual)
Primary Completion Date
February 9, 2019 (Actual)
Study Completion Date
February 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holland Bloorview Kids Rehabilitation Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This study has two sets of aims. The first are related to social and environmental experiences, and the second are related to anxiety experiences.
Aim 1: Social and environmental experiences
To qualitatively observe and understand the social and skill-building experiences of a knitting group for people with neurodevelopmental disorders, physical disabilities, and acquired brain injuries from the perspectives of participants, their parents, and program facilitators;
To explore whether a professionally facilitated knitting group is perceived to be a beneficial and/or enjoyable environment for people with neurodevelopmental disorders, physical disabilities, and acquired brain injuries to socialize with peers;
To explore whether a professionally facilitated knitting group is perceived as an appropriate and/or desired learning or skill building environment for people with neurodevelopmental disorders, physical disabilities, and acquired brain injuries; and
To collect data that will drive the creation of a manualized KneuroKnits program and funding for future quantitative outcome measurements of program success.
Aim 2: Anxiety
a. To evaluate the impact of a knitting instructional program on self report of anxiety in individuals with neurodevelopmental disorders, physical disabilities, and/or acquired brain injuries.
Program design:
The KneuroKnits program will be based upon current knitting education practices and leading practices in facilitation of social participation for youth 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. The project involves two pilot runs of the program in a pre-post study design.
Research Design:
The research includes both qualitative and quantitative components, all of which align with the structure of the KneuroKnits program described above. The project has two complementary foci that will be evaluated separately: (1) social and skill based experiences of program participation, and (2) the impact of program participation on anxiety related responses.
Social and skill based experiences of program participation:
Primarily using qualitative design driven by an interpretive phenomenological methodology, this study will explore program experiences using observation and interviews with participants and stakeholders. The research team will also evaluate the program environment (activity setting) using a validated measure (SEAS).
The impact of program participation on anxiety related responses:
This study will employ a pre-post design. Anxiety will be measured at 2 time points for all participants (baseline, week 4) using self report (the anxiety subscale of the Symptom Checklist 90 [SCL-90] and the State-Trait Anxiety Inventory [STAI] will be collected when the participant attends the relevant KneuroKnits session. If the participant misses that particular session, they will be asked to come in to Holland Bloorview at their earliest convenient time to complete the measures.
The program will be administered at two different sites to increase access to a broad population. In October-November 2018, the 4-week program will be conducted at the Ontario Science Centre site, and in November-December 2018, the program will be conducted at the Holland Bloorview site.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Neurodevelopmental Disorders, Acquired Brain Injury, Physical Disability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KneuroKnits group
Arm Type
Experimental
Arm Description
Participants in the KneuroKnits group
Intervention Type
Other
Intervention Name(s)
KneuroKnits
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-reported Experience of Activity Settings (SEAS)
Description
The SEAS is a validated measure of participants' self-reports of their experiences of activity settings.
Time Frame
End of first session (week 1)
Title
Self-reported Experience of Activity Settings (SEAS)
Description
The SEAS is a validated measure of participants' self-reports of their experiences of activity settings.
Time Frame
End of last session (week 4)
Title
Symptom Checklist-90 (SCL-90; anxiety subscale; change during program participation)
Description
The SCL-90 has been used to evaluate anxiety in adults with ASD and is a broadly used measure in adults.
Time Frame
Week 1
Title
Symptom Checklist-90 (SCL-90; anxiety subscale; change during program participation)
Description
The SCL-90 has been used to evaluate anxiety in adults with ASD and is a broadly used measure in adults.
Time Frame
Week 4
Title
State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)
Description
Measure of current symptoms of anxiety.
Time Frame
Beginning of Session 1 (week 1)
Title
State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)
Description
Measure of current symptoms of anxiety.
Time Frame
End of Session 1 (week 1)
Title
State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)
Description
Measure of current symptoms of anxiety.
Time Frame
Beginning of Session 4 (week 4)
Title
State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)
Description
Measure of current symptoms of anxiety.
Time Frame
End of Session 4 (week 4)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
1) has engaged in self-harm or physical aggression in the past 6 months, due to safety risks with knitting needles
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Penner, MD
Organizational Affiliation
Holland Bloorview Kids Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G1R8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data may be shared upon reasonable request.
Learn more about this trial
KneuroKnits: Participation and Anxiety in People With Neurological Conditions Participating in a Knitting Group
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