NCT04168034

Brief 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. This study will compare two groups of parents: those who are in the iParent2Parent program and those in the control group (no mentor).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

7 months

First QC Date

October 18, 2019

Last Update Submit

April 1, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    At study completion; an average of 2 years

Secondary Outcomes (4)

  • PROMIS Adult Profile 25

    baseline; up to 12 weeks after baseline, 6 months post program

  • Short form version of the PROMIS

    baseline; up to 12 weeks after baseline, 6 months post program

  • Coping Health Inventory for Parents

    baseline; up to 12 weeks after baseline, 6 months post program

  • Parental Stress Scale

    baseline; up to 12 weeks after baseline, 6 months post program

Study Arms (2)

Experimental: iParent2Parent Mentorship

EXPERIMENTAL

10 sessions of 20-30 minute Skype video calls conducted over 2 to 3 months

Behavioral: iParent2Parent Program

Waitlist Control Group

ACTIVE COMPARATOR

The control group will receive standard care but without the iParent2Parent program

Behavioral: Waitlist Control

Interventions

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.

Experimental: iParent2Parent Mentorship

The control group will receive standard care but without the iParent2Parent program

Waitlist Control Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Study Officials

  • Sara Ahola Kohut, PhD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

October 18, 2019

First Posted

November 19, 2019

Study Start

August 15, 2019

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

April 6, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations