Autism Spectrum DisorderNCT04639570
KneuroKnits: Participation and Anxiety in People With Neurological Conditions Participating in a Knitting Group
A study testing KneuroKnits in people with Autism Spectrum Disorder and Neurodevelopmental Disorders, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Autism Spectrum Disorder, Neurodevelopmental Disorders, Acquired Brain Injury
- What is being tested?
- KneuroKnits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- 3 Nov 2018to 9 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 1) has engaged in self-harm or physical aggression in the past 6 months, due to safety risks with knitting needles
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G1R8
About this study
Official title: KneuroKnits: Evaluating Social Participation and Anxiety Response Associated With Participation in a Knitting Group for People With Neurological Conditions (Pilot Study)
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.
Read the 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
- 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.
- Conditions
- Autism Spectrum Disorder, Neurodevelopmental Disorders, Acquired Brain Injury, Physical Disability
- Being tested
- KneuroKnits
- Medical subject headings
- Autism Spectrum Disorder, Neurodevelopmental Disorders, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KneuroKnitsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| KneuroKnits group | Experimental | Participants in the KneuroKnits group Receives: Other: KneuroKnits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Experience of Activity Settings (SEAS)
The SEAS is a validated measure of participants' self-reports of their experiences of activity settings.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of Session 4 (week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start3 Nov 2018
- Primary completion9 Feb 2019
- Study completion9 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melanie Penner, MD, Principal investigator, Holland Bloorview Kids Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639570
- Sponsor's protocol ID
- 17-717
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data may be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KneuroKnits: Evaluating Social Participation and Anxiety Response Associated With Participation in a Knitting Group for People With Neurological Conditions (Pilot Study)
- ClinicalTrials.gov ID
- NCT04639570
- Acronym / sponsor ID
- 17-717
- Conditions
- Autism Spectrum Disorder, Neurodevelopmental Disorders, Acquired Brain Injury, Physical Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- 3 Nov 2018 (actual)
- Primary completion
- 9 Feb 2019 (actual)
- Study completion
- 9 Feb 2019 (actual)
- First posted
- 20 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KneuroKnits group | Experimental | Other: KneuroKnitsParticipants in the KneuroKnits group |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 1) has engaged in self-harm or physical aggression in the past 6 months, due to safety risks with knitting needles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KneuroKnitsThe 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. | Other | KneuroKnits group |
Primary outcome
Self-reported Experience of Activity Settings (SEAS)
Time frame: End of first session (week 1)
The SEAS is a validated measure of participants' self-reports of their experiences of activity settings.
Self-reported Experience of Activity Settings (SEAS)
Time frame: End of last session (week 4)
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)
Time frame: Week 1
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)
Time frame: Week 4
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)
Time frame: Beginning of Session 1 (week 1)
Measure of current symptoms of anxiety.
State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)
Time frame: End of Session 1 (week 1)
Measure of current symptoms of anxiety.
State-Trait Anxiety Inventory (STAI; change between beginning and end of sessions; change between weeks 1 and 4)
Time frame: Beginning of Session 4 (week 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)
Time frame: End of Session 4 (week 4)
Measure of current symptoms of anxiety.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Individual participant dataSharing planned: No. Data may be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie Penner, MD principal investigator
Holland Bloorview Kids Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KneuroKnits in people with Autism Spectrum Disorder and Neurodevelopmental Disorders, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Experience of Activity Settings (SEAS) (time frame: End of first session (week 1)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.