Development of Psychotherapeutic Interventions for Parents Who Lost a Child
Development of Psychotherapeutic Interventions for Parents Who Lost a Child
Many parents who have lost a child use counseling or other resources to help with the
 emotional burden of their loss. The aim of this study is to begin to test a new counseling
 program for parents who have lost a child.
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 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=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.

 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.
Inclusion Criteria:

 -  Loss of a child at least 6 months

 -  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 able to complete sessions
 while complying with current telehealth regulations.

 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 able to complete sessions while complying
 with current telehealth regulations.

 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