Parents Who Have Lost a ChildNCT02153619
Development of Psychotherapeutic Interventions for Parents Who Lost a Child
A study testing Meaning-Centered Grief Therapy (MCGT), Supportive Psychotherapy (SP) and questionnaires assessments in people with Parents Who Have Lost a Child, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Parents Who Have Lost a Child
- What is being tested?
- Meaning-Centered Grief Therapy (MCGT), Supportive Psychotherapy (SP) and questionnaires assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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.
Read the 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.
- Conditions
- Parents Who Have Lost a Child
- Being tested
- Meaning-Centered Grief Therapy (MCGT), Supportive Psychotherapy (SP), questionnaires assessments
- Keywords
- Grief, bereavement, questionnaires, therapy sessions, 14-102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meaning-Centered Grief Therapy (MCGT)Behavioural
MCGT is a manualized, one-on-one intervention that uses psychoeducation, experiential exercises, and homework focusing on themes related to meaning, identity, purpose, and legacy. Post-intervention qualitative exit interviews will assess acceptability of the MCGT intervention (see Appendix I). Participants randomized to MCGT will provide their feedback about MCGT and the measures (n = 33).
Supportive Psychotherapy (SP)Behavioural
"SP is the comparison condition in this study and is a standardized, manualized intervention developed by the MSK Psychiatry Service and utilized in our completed and ongoing RCTs of Meaning-Centered Psychotherapy."
questionnaires assessmentsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Meaning-Centered Grief Therapy (MCGT) | Experimental | Part 1: Open Trials. Participants (n = 5 for Step 1 \& n = 5 for Step 2) will receive 16 1-hour (approx) weekly sessions MCGT, \& all therapy sessions will be audio recorded. Will make every effort to complete 16 sessions in 16 weeks, due to normal life activities, this is considered an approximation (i.e. there may be weeks where sessions don't take place \&/or weeks where more than 1 session takes place in a week). If participant provides us with permission, we will also video record the sessions. Assessments will be administered at 4 time points: pre-intervention (T1), mid-intervention (T2), post-intervention (T3), \& at 3-months post-intervention (T4). They will provide their feedback about MCGT \& the measures. PI will review the open trial sessions to help refine the MCGT manual \& treatment integrity forms. Sessions for Step 1 participants in Part 1 will be held at the MSK Counseling Center. Sessions for Step 2 participants in Part 1 will be conducted via videoconferencing. Receives: Behavioral: Meaning-Centered Grief Therapy (MCGT); Behavioral: questionnaires assessments |
| MCGT or Supportive Psychotherapy | Experimental | Part 2: Pilot RCT. Will randomize 66 parents to 16 weekly 60-90 minute (approx) sessions of MCGT or SP delivered via videoconferencing. Again, sessions will be audio recorded. If the participant provides us with permission, we also audio/video record the sessions. We will examine aspects of study implementation \& therapy process, including a) recruitment progress, b) implementation of the intervention, c) administration of the assessments, \& d) retention. We will also examine acceptability, defined as measures of satisfaction at T3. Psychosocial outcomes will be assessed with self-report measures at 4 time points: pre-intervention (T1), mid-intervention (T2), post-intervention (T3), \& at 3-months post-intervention (T4). Post-intervention qualitative exit interviews will assess acceptability of the intervention. Post-intervention qualitative exit interviews will assess acceptability of the MCGT intervention . Receives: Behavioral: Meaning-Centered Grief Therapy (MCGT); Behavioral: Supportive Psychotherapy (SP); Behavioral: questionnaires assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 years
psychological outcome data in prolonged grief symptoms, assessed with the PG-13 summary score.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parents Who Have Lost a ChildStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Memphis, University of Hawaii, Adelphi University, Weill Medical College of Cornell University, University of Southern California, The New School for Social Research, Monash University
- Responsible party
- Sponsor
- Investigators
- Talia Zaider, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02153619
- Sponsor's protocol ID
- 14-102
- Status last verified
- Jun 2026
- First submitted
- 22 May 2014
- Last updated
- 4 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Psychotherapeutic Interventions for Parents Who Lost a Child
- ClinicalTrials.gov ID
- NCT02153619
- Acronym / sponsor ID
- 14-102
- Conditions
- Parents Who Have Lost a Child
- Keywords
- Grief, bereavement, questionnaires, therapy sessions, 14-102
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of Memphis, University of Hawaii, Adelphi University, Weill Medical College of Cornell University, University of Southern California, The New School for Social Research, Monash University
- Study start
- May 2014 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meaning-Centered Grief Therapy (MCGT) | Experimental | Behavioral: Meaning-Centered Grief Therapy (MCGT), Behavioral: questionnaires assessmentsPart 1: Open Trials. Participants (n = 5 for Step 1 \& n = 5 for Step 2) will receive 16 1-hour (approx) weekly sessions MCGT, \& all therapy sessions will be audio recorded. Will make every effort to complete 16 sessions in 16 weeks, due to normal life activities, this is considered an approximation (i.e. there may be weeks where sessions don't take place \&/or weeks where more than 1 session takes place in a week). If participant provides us with permission, we will also video record the sessions. Assessments will be administered at 4 time points: pre-intervention (T1), mid-intervention (T2), post-intervention (T3), \& at 3-months post-intervention (T4). They will provide their feedback about MCGT \& the measures. PI will review the open trial sessions to help refine the MCGT manual \& treatment integrity forms. Sessions for Step 1 participants in Part 1 will be held at the MSK Counseling Center. Sessions for Step 2 participants in Part 1 will be conducted via videoconferencing. |
| MCGT or Supportive Psychotherapy | Experimental | Behavioral: Meaning-Centered Grief Therapy (MCGT), Behavioral: Supportive Psychotherapy (SP), Behavioral: questionnaires assessmentsPart 2: Pilot RCT. Will randomize 66 parents to 16 weekly 60-90 minute (approx) sessions of MCGT or SP delivered via videoconferencing. Again, sessions will be audio recorded. If the participant provides us with permission, we also audio/video record the sessions. We will examine aspects of study implementation \& therapy process, including a) recruitment progress, b) implementation of the intervention, c) administration of the assessments, \& d) retention. We will also examine acceptability, defined as measures of satisfaction at T3. Psychosocial outcomes will be assessed with self-report measures at 4 time points: pre-intervention (T1), mid-intervention (T2), post-intervention (T3), \& at 3-months post-intervention (T4). Post-intervention qualitative exit interviews will assess acceptability of the intervention. Post-intervention qualitative exit interviews will assess acceptability of the MCGT intervention . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (7 listed)
- 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.
- Significant psychiatric disturbance sufficient, in the investigator's judgment, to preclude completion of the assessment measures, interview or informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meaning-Centered Grief Therapy (MCGT)MCGT is a manualized, one-on-one intervention that uses psychoeducation, experiential exercises, and homework focusing on themes related to meaning, identity, purpose, and legacy. Post-intervention qualitative exit interviews will assess acceptability of the MCGT intervention (see Appendix I). Participants randomized to MCGT will provide their feedback about MCGT and the measures (n = 33). | Behavioural | MCGT or Supportive Psychotherapy, Meaning-Centered Grief Therapy (MCGT) |
| Supportive Psychotherapy (SP)"SP is the comparison condition in this study and is a standardized, manualized intervention developed by the MSK Psychiatry Service and utilized in our completed and ongoing RCTs of Meaning-Centered Psychotherapy." | Behavioural | MCGT or Supportive Psychotherapy |
| questionnaires assessments | Behavioural | MCGT or Supportive Psychotherapy, Meaning-Centered Grief Therapy (MCGT) |
Primary outcome
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
Time frame: 4 years
psychological outcome data in prolonged grief symptoms, assessed with the PG-13 summary score.
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
Related trials for Parents Who Have Lost a Child
Active, not recruitingObservational study
Understanding the Psychosocial Needs of Parents Who Have Lost a Child to Cancer
Parents Who Have Lost a Child to Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Talia Zaider, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meaning-Centered Grief Therapy (MCGT), Supportive Psychotherapy (SP) and questionnaires assessments in people with Parents Who Have Lost a Child, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.