iParent2Parent Program for Parents of Children With Juvenile Idiopathic Arthritis (iPa2PaJIA)

April 1, 2021 updated by: Sara Ahola Kohut, The Hospital for Sick Children

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • The IWK Health Centre
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental: iParent2Parent Mentorship
10 sessions of 20-30 minute Skype video calls conducted over 2 to 3 months
Behavioral: iParent2Parent Program
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.
ACTIVE_COMPARATOR: Waitlist Control Group
The control group will receive standard care but without the iParent2Parent program
Behavioral: Waitlist Control
The control group will receive standard care but without the iParent2Parent program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At study completion; an average of 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PROMIS Adult Profile 25
Time Frame: baseline; up to 12 weeks after baseline, 6 months post program
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
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
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)
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
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.
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
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.
baseline; up to 12 weeks after baseline, 6 months post program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 16, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 19, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000061063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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