临床试验雷达

Step 1 of Part 1 will involve a brief open trial of MCGT delivered in person at an MSK location with individual parents (n=5) to further refine the treatment through active participant feedback and identify ways to improve therapeutic alliance to maximize the impact of delivery via videoconferencing. Parents may also invite a support provider to join them for Session 9 (support provider n = 5). Support providers will not be evaluated as research participants.

Step 2 of Part 1 will be another brief open trial (n=5) delivering MCGT via video conferencing to iron out any logistical challenges prior to the pilot randomized controlled trial (RCT). The investigators hope to use videoconferencing in order to ultimately improve parents' access to supportive services. Participants will be able to complete sessions wherever they have both privacy and access to a computer and the internet. Parents may also invite a support provider to join them for Session 9 (support provider n = 5). Support providers will not be evaluated as research participants.

All Part 1 participants will be assessed pre-intervention (T1), mid-intervention (T2), post-intervention (T3), and at 3-months post-intervention (T4). A qualitative exit interview will also be conducted post-intervention. This interview will be audio recorded. Video recording of the exit interview will be optional. Throughout both steps, parent testimonials that address barriers to accessing mental health services will be obtained to assist in Part 2 outreach and recruitment.

Part 1 will be conducted with parents experiencing elevated PGD symptoms as measured by the PG-13, a 13-item self-report scale evaluating PGD symptom severity, duration, and impairment. For this study, PG-13 scores ≥ 34 will be considered indicative of elevated PGD symptoms.

Part 2 will be used to obtain information about the feasibility, tolerability, acceptability, and effect size estimates of MCGT (delivered via video conferencing) to assist in planning a larger, efficacy RCT. These goals will be accomplished by undertaking a parallel-arm RCT comparing the refined MCGT to a standardized supportive psychotherapy (SP), both one-on-one interventions delivered via videoconferencing, which numerous studies show is as efficacious as in-person delivery.15-17 Parents (n=56) with PG-13 scores ≥ 34 will be randomized to receive MCGT or SP to compare their relative feasibility, acceptability, tolerability, and preliminary effects. As in Part 1, participants will be assessed pre-intervention (T1), mid-intervention (T2), post-intervention (T3), and at 3-months post-intervention (T4). All psychotherapy sessions for Part 1 will need to be completed before Part 2 begins. The investigators expect that they will be able to begin Part 2 of the protocol (during which recruits 56 parents) approximately 3 months after the final parent is enrolled in Part 1, Step 2. Approximately 56 parents (individuals) will complete the intervention in Part 2.Parents randomized to MCGT may also invite a support provider to join them for Session 9 (support provider n = 28). Support providers will not be evaluated as research participants. 1-2 training cases per MCGT interventionist (rather than randomized) will also be enrolled on this study for training purposes. There may be weeks where sessions do not take place and/or weeks where more than one session takes place in a week.

Past participants on the study may also be contacted to join a Parent Advisory Board (PAB) Potential members of PAB may also be identified from the community. Members of the PAB will be invited to provide their perspectives, ideas, and feedback on the intervention and ongoing and future research.