JIAiPa2PaJIANCT04168034
iParent2Parent Program for Parents of Children With Juvenile Idiopathic Arthritis
A study testing iParent2Parent Program in people with JIA, run by The Hospital for Sick Children at 2 sites in Canada.
Trial summary
The iParent2Parent program matches parents of children living with arthritis with a trained parent mentor who will provide parents of children newly diagnosed with arthritis: practical coping advice and social support through shared lived experiences. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- JIA
- What is being tested?
- iParent2Parent Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Aug 2019to 16 Mar 2020
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking caregiver of a child diagnosed with JIA according to ILAR criteria prior to their 18th birthday
- Access to computer capable of using free Skype software
Who cannot join
- Significant cognitive impairment or major co-morbid illness of parent that impeded ability to engage in program (e.g.; psychosis, active suicidal ideation, cognitive delays that would impact ability to participate and complete questionnaires.)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: The iParent2Parent Program: Peer Mentoring for Parents of Children With Juvenile Idiopathic Arthritis
The iParent2Parent program matches parents of children living with arthritis with a trained parent mentor who will provide parents of children newly diagnosed with arthritis: practical coping advice and social support through shared lived experiences. This study will compare two groups of parents: those who are in the iParent2Parent program and those in the control group (no mentor).
Read the detailed description
Parents/primary caregiver of children with JIA are an often overlooked but essential member of their child's health care team. They are responsible for managing their child's treatment program, and act as advocates for their child to support positive adaptation to JIA and to learn self-management skills for the disease. This is in the context of managing the financial, logistical, emotional, and social demands of parenting in general. Within pediatric tertiary care centres, peer-support programs for parents of children with JIA are often limited or difficult to access. The iParent2Parent Program aims to fill this gap in services by offering a program of trained parent peer mentors who can provide practical coping advice, foster adaptive problem solving, and provide social support via shared lived experience.
- Conditions
- JIA
- Being tested
- iParent2Parent Program, Waitlist Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iParent2Parent ProgramBehavioural
In addition to standard care, parents in the experimental group will receive the iParent2Parent program. The iParent2Parent program is a tailored peer mentorship program that provides modeling and reinforcement by peers (trained parents of children with JIA) to parents of children diagnosed with JIA.
Waitlist ControlBehavioural
The control group will receive standard care but without the iParent2Parent program
| Study group | Role | What they receive |
|---|---|---|
| Experimental: iParent2Parent Mentorship | Experimental | 10 sessions of 20-30 minute Skype video calls conducted over 2 to 3 months Receives: Behavioral: iParent2Parent Program |
| Waitlist Control Group | Active comparator | The control group will receive standard care but without the iParent2Parent program Receives: Behavioral: Waitlist Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial feasibility of iParent2Parent program
Criteria for feasibility are based on studies previously conducted by our group and will be: accrual rate of >70 percent, attrition rate of <15percent, technical difficulties reported by <10 percent of parents and mentors, adherence rate of >80 percent, <5 percent missed responses on outcome measures and high acceptability (based on qualitative analyses). Data related to the primary outcome will be recorded on investigator-developed forms.
Measured: At study completion; an average of 2 years
Secondary outcomes (4)
PROMIS Adult Profile 25
29 item collection of short forms from 7 health domains: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance and ability to participate in social roles and activities. The scale is scored from 1 to 5. The higher the score the worse the outcome
Measured: baseline; up to 12 weeks after baseline, 6 months post program
Short form version of the PROMIS
Short form version of the PROMIS battery for Social Isolation; Informational support; and Emotional support. The scale is scored from 1 to 5. The higher the score the better the outcome (emotional and informational support). The higher the score the worse the outcome for social isolation)
Measured: baseline; up to 12 weeks after baseline, 6 months post program
Coping Health Inventory for Parents
45-item measure of a parent's response to managing demands when a child has a serious or chronic medical condition. The lower the score, the worse the outcome. Minimum value 0 and maximum value 3.
Measured: baseline; up to 12 weeks after baseline, 6 months post program
Parental Stress Scale
Attempts to measure the levels of stress experienced by parents. The scale is scored from 1 to 5. The lower the score the lower the level of stress and the higher the score the higher the level of stress.
Measured: baseline; up to 12 weeks after baseline, 6 months post program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start15 Aug 2019
- Primary completion16 Mar 2020
- Study completion16 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for JIAStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ahola Kohut, The Hospital for Sick Children
- Investigators
- Sara Ahola Kohut, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168034
- Sponsor's protocol ID
- 1000061063
- Acronym
- iPa2PaJIA
- Status last verified
- Apr 2021
- First submitted
- 18 Oct 2019
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The iParent2Parent Program: Peer Mentoring for Parents of Children With Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT04168034
- Acronym / sponsor ID
- iPa2PaJIA / 1000061063
- Conditions
- JIA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 16 Mar 2020 (actual)
- Study completion
- 16 Mar 2020 (actual)
- First posted
- 19 Nov 2019 (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 iParent2Parent program matches parents of children living with arthritis with a trained parent mentor who will provide parents of children newly diagnosed with arthritis: practical coping advice and social support through shared lived experiences. This study will compare two groups of parents: those who are in the iParent2Parent program and those in the control group (no mentor).
Detailed description
Parents/primary caregiver of children with JIA are an often overlooked but essential member of their child's health care team. They are responsible for managing their child's treatment program, and act as advocates for their child to support positive adaptation to JIA and to learn self-management skills for the disease. This is in the context of managing the financial, logistical, emotional, and social demands of parenting in general. Within pediatric tertiary care centres, peer-support programs for parents of children with JIA are often limited or difficult to access. The iParent2Parent Program aims to fill this gap in services by offering a program of trained parent peer mentors who can provide practical coping advice, foster adaptive problem solving, and provide social support via shared lived experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: iParent2Parent Mentorship | Experimental | Behavioral: iParent2Parent Program10 sessions of 20-30 minute Skype video calls conducted over 2 to 3 months |
| Waitlist Control Group | Active comparator | Behavioral: Waitlist ControlThe control group will receive standard care but without the iParent2Parent program |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- English speaking caregiver of a child diagnosed with JIA according to ILAR criteria prior to their 18th birthday
- Access to computer capable of using free Skype software
Key exclusion criteria (1 listed)
- Significant cognitive impairment or major co-morbid illness of parent that impeded ability to engage in program (e.g.; psychosis, active suicidal ideation, cognitive delays that would impact ability to participate and complete questionnaires.)
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 |
|---|---|---|
| iParent2Parent ProgramIn addition to standard care, parents in the experimental group will receive the iParent2Parent program. The iParent2Parent program is a tailored peer mentorship program that provides modeling and reinforcement by peers (trained parents of children with JIA) to parents of children diagnosed with JIA. | Behavioural | Experimental: iParent2Parent Mentorship |
| Waitlist ControlThe control group will receive standard care but without the iParent2Parent program | Behavioural | Waitlist Control Group |
Primary outcome
Trial feasibility of iParent2Parent program
Time frame: At study completion; an average of 2 years
Criteria for feasibility are based on studies previously conducted by our group and will be: accrual rate of >70 percent, attrition rate of <15percent, technical difficulties reported by <10 percent of parents and mentors, adherence rate of >80 percent, <5 percent missed responses on outcome measures and high acceptability (based on qualitative analyses). Data related to the primary outcome will be recorded on investigator-developed forms.
4 secondary outcomes
PROMIS Adult Profile 25
Time frame: baseline; up to 12 weeks after baseline, 6 months post program
Short form version of the PROMIS
Time frame: baseline; up to 12 weeks after baseline, 6 months post program
Coping Health Inventory for Parents
Time frame: baseline; up to 12 weeks after baseline, 6 months post program
Parental Stress Scale
Time frame: baseline; up to 12 weeks after baseline, 6 months post program
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 6 Apr 2021.
- Individual participant dataSharing planned: No
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An Open-label Study to Evaluate the Pharmacokinetics and Safety of Bimekizumab in Pediatric Study Participants With Active Juvenile Idiopathic Arthritis Subtypes Enthesitis-related Arthritis (Including Juvenile-onset Ankylosing Spondylitis) and Juvenile Psoriatic Arthritis
Enthesitis-related Arthritis, Juvenile Psoriatic Arthritis
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.
Sara Ahola Kohut, PhD principal investigator
The Hospital for Sick Children
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iParent2Parent Program in people with JIA, run by The Hospital for Sick Children at 2 sites 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 2 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 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Trial feasibility of iParent2Parent program (time frame: At study completion; an average of 2 years). 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 6 Apr 2021.