Development of Psychotherapeutic Interventions for Parents Who Lost a Child to Cancer

There are two parts to this study. Adapting and refining the MCGT intervention manual will be
accomplished primarily in Part 1, building upon a preparatory project to obtain feedback on
the MCGT intervention manual and materials.

Step 1 of Part 1 will involve a brief open trial of MCGT delivered in person at an MSKCC
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 the proposed diagnostic criteria of Prolonged
Grief Disorder, including 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=66) 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 66 parents) approximately 3 months after the final parent is enrolled in Part 1,
Step 2. Approximately 66 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 = 33). Support providers will not be evaluated as research participants.
There may be weeks where sessions do not take place and/or weeks where more than one session
takes place in a week.

Inclusion Criteria:

- Loss of a child at least 6 months ago who had been diagnosed with cancer as reported
in the child's medical record or by parent report

- Loss of a child 39 years old or younger as reported in the child's medical record or
by parent report

- Biological or adoptive parent or stepparent as reported in the child's medical record
or by parent report

- Parent must be age 18 or over as reported by parent

- In the judgment of investigators/consenting professionals, able to comprehend English
to complete study assessments

- Score of 34 or greater ( ≥ 34) on the PG-13 at screening

- Residing in New York, New Jersey, Connecticut, or Pennsylvania for P1S1; Residing in
New York for P1S2; residing in New York or New Jersey or ability to complete sessions
in New York or New Jersey for Part 2, as reported in the child's medical record or by
parent report.

Support Provider Inclusion Criteria:

- Must be age 18 or over as indicated by self-report

- Has been identified by the bereaved parent participant as a support or someone
important to bereaved parent

- Must reside in New York or New Jersey or ability to complete sessions in New York or
New Jersey

Exclusion Criteria:

- Significant psychiatric disturbance sufficient, in the investigator's judgment, to
preclude completion of the assessment measures, interview or informed consent

- Inability to access a computer with Internet or inability to use a computer with
Internet provided by the study as indicated by self-report

- Another parent or primary caregiver of the child has been enrolled in the study

- For the Part 2 RCT, participated in Part 1, Step 1 or 2.

Support Provider Exclusion Criteria:

- Significant psychiatric disturbance sufficient, in the investigator's judgment, to
preclude completion of the assessment measures, interview or informed consent

- Inability to access a computer with Internet or inability to use a computer with
Internet provided by the study as indicated by self-report