Table 4 Resulting modifications to trial and application of findings

Recruitment

• Ensuring all participants have effective ways of participating in decision-making structures and feeling that they have a real say in them. This will, in part, be achieved through semi-annual PACT meetings.

• Engaging in good practices in regarding health literacy (speaking slowly, avoiding jargon and acronyms, repeating points to improve comprehension, encourage and expect all patients to ask questions, check understanding and recall).

• While the research team has encountered difficulties in developing an online system for parent participants to interact due to privacy concerns, we have raised the idea of participants sharing emails or engaging in a Facebook group if preferred.

• Embracing different forms and methods of involvement. In addition to in-person contact, consider the possibility of implementing telephone or online discussions with participating families to collect data. Utilizing a variety of media to interact with families will help address barriers related to time constraints and lack of childcare provision.

• Collaborating with the Early Childhood Education program at a local college to offer free childcare (to increase accessibility of trial to participants).

• Reducing the number of sessions with public health nurse from 10 to 8 (to accommodate parent’s busy schedules).

• Providing the option for parents to join the sessions via Zoom, videoconference (to accommodate parent’s busy schedules)

Engagement

• Developing new recruitment material using various media to promote the study and provide important information about the trial.

 ◦ A whiteboard video that can be emailed to eligible participants at recruitment.

 ◦ A revised recruitment poster that can be displayed in medical offices.

 ◦ Using different coloured paper to help participants differentiate between different studies they may be participating in within the TARGet Kids! cohort

• Providing further explanation to potential participants regarding the purpose of the PARENT trial, and revising plans to better communicate findings from this work with participants promptly and in a more accessible manner.

Intervention

• Providing an option to use online conference calling for group sessions, providing childcare during sessions

• Re-formatting the questionnaires to assist in completion

• Ensuring that participating parents feel their involvement and contributions is being taken seriously and integrated where possible. This will include taking findings from the focus group, modifying research approaches (where possible/appropriate), and touching base with participating families throughout the trial.

• Developing a feedback page to report results of baseline findings to be provided to the family and reviewed at the home visit with the public health nurse.

• Developed an integrated curriculum with existing evidence-informed program, Chicago parent program, for the intervention program.

• Added a follow-up visit at 12 months (to evaluate effectiveness of intervention in the longer term; to determine if changed in outcome measures are different, same with the baseline and 6-month follow-up).

• Added coaching calls (to improve engagement and rapport between public health nurse and participant).