Clinical trial NCT02153619: Development of Psychotherapeutic Interventions for Parents Who Lost a Child
Official title: Development of Psychotherapeutic Interventions for Parents Who Lost a Child
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parents Who Have Lost a Child
Keywords: Grief
bereavement
questionnaires
therapy sessions
14-102
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Memphis
name: University of Hawaii
name: Adelphi University
name: Weill Medical College of Cornell University
name: University of Southern California
name: The New School for Social Research
name: Monash University
First posted: 2014-06-03
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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=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.

Eligibility criteria: 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 (N/A for training case participants)
* 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 (N/A for training case participants)
* 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

Primary outcomes:
measure: feasibility defined and measured as the proportion of participants who complete at least 8 out of 16 sessions of therapy as well as completion of the T3 PG-13 assessment
timeFrame: 4 years
measure: psychological outcome data in prolonged grief symptoms, assessed with the PG-13 summary score.
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Talia Zaider, PhD
role: PRINCIPAL_INVESTIGATOR
References: