BereavementADAPTNCT04929405
Pilot Testing ADAPT a Bereavement Care Intervention
A study testing ADAPT in people with Bereavement, run by East Carolina University at 2 sites in United States.
Trial summary
Parental bereavement experiences are unique and require interventions adaptable to individual experiences.The web-based, multi-modal intervention, labeled ADAPT, incorporates varied self-management strategies including: A: Asking for assistance (option to connect with child's healthcare team); DA: Developing Adaptive… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bereavement
- What is being tested?
- ADAPT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Mar 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Biological parent and legal guardian of a deceased child who was 18 years old or younger at time of death
- Cause of death of the deceased child is illness
- Parent age 18 years or older at time of child's death
- Ability to speak and read English sufficient to participate in the study
Who cannot join
- Step-, foster-, grand- or fictive parent of a child who has died
- Deceased child was unborn or over age 18 years at time of death
- Deceased child was in legal custody of county or state jurisdiction
- Cause of child's death was in utero or traumatic
- Parent age less than 18 years
- Inability to speak and read English sufficient to participate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Akron Children's Hospital
Akron, Ohio, 44308
Cardinal Glennon Childrens Hospital
St Louis, Missouri, 63104
About this study
Official title: Pilot-Testing a Theoretically Based Digital Intervention for Bereaved Parents (ADAPT)
Parental bereavement experiences are unique and require interventions adaptable to individual experiences.The web-based, multi-modal intervention, labeled ADAPT, incorporates varied self-management strategies including: A: Asking for assistance (option to connect with child's healthcare team); DA: Developing Adaptive ability (self-management tools: e.g. stress reduction, legacy building); P: Accessing Pertinent online resources (grief support networks/websites); and T: Tracking one's health (self-administered surveys for grief, sleep, anxiety, and depression). A quasi-experimental, treatment-only design will be used for this study. The hypothesis is that the ADAPT intervention will promote positive adaptation to influence grief integration and consequently affect health outcomes (improved sleep and social interactions, and decreased anxiety and depressive symptoms).The purpose of this study is to describe the nature and degree of clinical benefit of the intervention on bereaved parents' health outcomes.
Read the detailed description
ADAPT, is multi-modal intervention that promotes a targeted approach to individual parental bereavement experiences. ADAPT is based on the theoretical foundations of the Adaptive Leadership (AL) framework. ADAPT, incorporates varied self-management strategies including: A: Asking for assistance (option to connect with child's healthcare team); DA: Developing Adaptive ability (self-management tools: e.g. stress reduction, legacy building); P: Accessing Pertinent online resources (grief support networks/websites); and T: Tracking one's health (self-administered surveys for grief, sleep, anxiety, and depression). Parents can download ADAPT on any digital device (phones/computers) using weblink.
- Study Purpose and Objective(s)
The purpose of this study is to describe the nature and degree of clinical benefit of the intervention on bereaved parents' health outcomes. The Specific Aims are:
Aim 1: Assess the acceptability and feasibility of the ADAPT intervention components. Acceptability will be assessed with a modified standardized acceptability survey and cognitive interviews. Feasibility will be assessed by accrual (recruitment), attrition, and intervention engagement (i.e., frequency, duration, and interaction). Intervention engagement data will be obtained via Google analytics and cognitive interviews.
Hypothesis 1.1: ADAPT is acceptable to participants (> 80% acceptability based on survey).
Hypothesis 1.2: Delivery of ADAPT is feasible in terms of accrual (N=30), attrition (15%), and intervention engagement (minimally accessed 3 times for >15 minutes and used at least 2 self-management strategies) Aim 2: Determine if the use of the ADAPT intervention components results in a clinically meaningful change in grief integration (Brief Grief Questionnaire) and bereaved parents' health outcomes (Visual Analogue Scale for overall health and PROMIS surveys for sleep, social isolation, anxiety, and depression). Hypothesis 2.1: After completing the ADAPT intervention, participants will demonstrate improvement in health outcome scores when compared to baseline (T0).
Design: quasi-experimental, treatment-only design. Sample: N=35 parents of children who have died while being followed for care at either Akron Children's Hospital or Cardinal Glennon Children's hospital.
Recruitment: Participants will be recruited into two groups. Group 1 will be parents whose child died 4 weeks (+ 2 weeks) prior; Group 2 will be parents whose child died three months (+/- 2 weeks) prior to enrollment. Either a mother or a father for any one child will be recruited.
For both the groups, a Study Information Sheet will be included in each bereavement packet sent or mailed home, at either 4 week (group 1) or 3 months (group 2) after the child has died. This Study Information Sheet will have a study-specific phone number and email address for a clinical research coordinator, through which the parent can immediately opt in or opt out. If there is no response following one to two weeks after the bereavement packet was sent, the bereaved parents will be contacted by study staff via telephone to assess interest, discuss the study, and answer any questions they may have. If the parent agrees to participate, econsent will be completed using REDCap. After completing the econsent, participants will have access to ADAPT and will be provided a REDCap survey link to allow self-completion of baseline questionnaires (T0) (see Table 1). Three months after completing the intervention (T1), participants will again be provided a REDCap survey link to post-intervention questionnaires (see Table.1). At that time, a semi-structured cognitive interview with participants will be scheduled. The interviews will be conducted via telephone and will be recorded, transcribed, and verified for accuracy by the study team.
- Conditions
- Bereavement
- Being tested
- ADAPT
- Keywords
- Bereavement, Palliative Care, Web-based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAPTBehavioural
ADAPT, is multi-modal to promote a targeted approach to individual parental bereavement experiences and is not time or geographically limited. ADAPT is based on the theoretical foundations of the Adaptive Leadership (AL) framework. Our interdisciplinary team developed a web-based, multi-modal intervention, labeled ADAPT, that incorporates varied self-management strategies including: A: Asking for assistance (option to connect with child's healthcare team); DA: Developing Adaptive ability (self-management tools: e.g. stress reduction, legacy building); P: Accessing Pertinent online resources (grief support networks/websites); and T: Tracking one's health (self-administered surveys for grief, sleep, anxiety, and depression). Parents can download ADAPT on any digital device (phones/computers) using a Quick Response (QR) bar code or weblink.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This group has access to the intervention (website for bereaved parents) Receives: Behavioral: ADAPT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruited 35 participants in the study timeframe
Measured: 3 months
Retention
Participants complete surveys at pre and post intervention.
Measured: 3 months
Secondary outcomes (5)
Sleep
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) sleep scores from baseline to 3 months. The final score for these PROMIS measures is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Scoring will be completed by uploading deidentified data to the Health Measures Scoring Service using the General and Clinical reference population.
Measured: 3 months
Grief
Change in grief scores of the Brief Grief Questionnaire from baseline to 3 months. If the participants score 4 or above they need full evaluation.
Measured: 3 months
Social isolation
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) social isolation scores from baseline to 3 months. The final score for these PROMIS measures is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Scoring will be completed by uploading deidentified data to the Health Measures Scoring Service using the General and Clinical reference population.
Measured: 3 months
Anxiety
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scores from baseline to 3 months. The final score for these PROMIS measures is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Scoring will be completed by uploading deidentified data to the Health Measures Scoring Service using the General and Clinical reference population.
Measured: 3 months
Depression
Change in the Patient-Reported Outcomes Measurement Information System (PROMIS) depression scores from baseline to 3 months. The final score for these PROMIS measures is represented by the T-score, a standardized score with a mean of 50 and a standard deviation (SD) of 10. Scoring will be completed by uploading deidentified data to the Health Measures Scoring Service using the General and Clinical reference population.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start3 Mar 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BereavementStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Palliative Care Research Cooperative Group, Akron Children's Hospital
- Responsible party
- Principal investigator, Nancy Dias, East Carolina University
- Investigators
- Nancy Dias, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929405
- Sponsor's protocol ID
- UMCIRB 19-001984
- Acronym
- ADAPT
- Status last verified
- Mar 2022
- First submitted
- 25 Aug 2020
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-Testing a Theoretically Based Digital Intervention for Bereaved Parents (ADAPT)
- ClinicalTrials.gov ID
- NCT04929405
- Acronym / sponsor ID
- ADAPT / UMCIRB 19-001984
- Conditions
- Bereavement
- Keywords
- Bereavement, Palliative Care, Web-based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- Palliative Care Research Cooperative Group, Akron Children's Hospital
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Jun 2021 (actual)
- 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.
Parental bereavement experiences are unique and require interventions adaptable to individual experiences.The web-based, multi-modal intervention, labeled ADAPT, incorporates varied self-management strategies including: A: Asking for assistance (option to connect with child's healthcare team); DA: Developing Adaptive ability (self-management tools: e.g. stress reduction, legacy building); P: Accessing Pertinent online resources (grief support networks/websites); and T: Tracking one's health (self-administered surveys for grief, sleep, anxiety, and depression). A quasi-experimental, treatment-only design will be used for this study. The hypothesis is that the ADAPT intervention will promote positive adaptation to influence grief integration and consequently affect health outcomes (improved sleep and social interactions, and decreased anxiety and depressive symptoms).The purpose of this study is to describe the nature and degree of clinical benefit of the intervention on bereaved parents' health outcomes.
Detailed description
ADAPT, is multi-modal intervention that promotes a targeted approach to individual parental bereavement experiences. ADAPT is based on the theoretical foundations of the Adaptive Leadership (AL) framework. ADAPT, incorporates varied self-management strategies including: A: Asking for assistance (option to connect with child's healthcare team); DA: Developing Adaptive ability (self-management tools: e.g. stress reduction, legacy building); P: Accessing Pertinent online resources (grief support networks/websites); and T: Tracking one's health (self-administered surveys for grief, sleep, anxiety, and depression). Parents can download ADAPT on any digital device (phones/computers) using weblink.
- Study Purpose and Objective(s)
The purpose of this study is to describe the nature and degree of clinical benefit of the intervention on bereaved parents' health outcomes. The Specific Aims are:
Aim 1: Assess the acceptability and feasibility of the ADAPT intervention components. Acceptability will be assessed with a modified standardized acceptability survey and cognitive interviews. Feasibility will be assessed by accrual (recruitment), attrition, and intervention engagement (i.e., frequency, duration, and interaction). Intervention engagement data will be obtained via Google analytics and cognitive interviews.
Hypothesis 1.1: ADAPT is acceptable to participants (> 80% acceptability based on survey).
Hypothesis 1.2: Delivery of ADAPT is feasible in terms of accrual (N=30), attrition (15%), and intervention engagement (minimally accessed 3 times for >15 minutes and used at least 2 self-management strategies) Aim 2: Determine if the use of the ADAPT intervention components results in a clinically meaningful change in grief integration (Brief Grief Questionnaire) and bereaved parents' health outcomes (Visual Analogue Scale for overall health and PROMIS surveys for sleep, social isolation, anxiety, and depression). Hypothesis 2.1: After completing the ADAPT intervention, participants will demonstrate improvement in health outcome scores when compared to baseline (T0).
Design: quasi-experimental, treatment-only design. Sample: N=35 parents of children who have died while being followed for care at either Akron Children's Hospital or Cardinal Glennon Children's hospital.
Recruitment: Participants will be recruited into two groups. Group 1 will be parents whose child died 4 weeks (+ 2 weeks) prior; Group 2 will be parents whose child died three months (+/- 2 weeks) prior to enrollment. Either a mother or a father for any one child will be recruited.
For both the groups, a Study Information Sheet will be included in each bereavement packet sent or mailed home, at either 4 week (group 1) or 3 months (group 2) after the child has died. This Study Information Sheet will have a study-specific phone number and email address for a clinical research coordinator, through which the parent can immediately opt in or opt out. If there is no response following one to two weeks after the bereavement packet was sent, the bereaved parents will be contacted by study staff via telephone to assess interest, discuss the study, and answer any questions they may have. If the parent agrees to participate, econsent will be completed using REDCap. After completing the econsent, participants will have access to ADAPT and will be provided a REDCap survey link to allow self-completion of baseline questionnaires (T0) (see Table 1). Three months after completing the intervention (T1), participants will again be provided a REDCap survey link to post-intervention questionnaires (see Table.1). At that time, a semi-structured cognitive interview with participants will be scheduled. The interviews will be conducted via telephone and will be recorded, transcribed, and verified for accuracy by the study team.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: ADAPTThis group has access to the intervention (website for bereaved parents) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biological parent and legal guardian of a deceased child who was 18 years old or younger at time of death
- Cause of death of the deceased child is illness
- Parent age 18 years or older at time of child's death
- Ability to speak and read English sufficient to participate in the study
Key exclusion criteria (6 listed)
- Step-, foster-, grand- or fictive parent of a child who has died
- Deceased child was unborn or over age 18 years at time of death
- Deceased child was in legal custody of county or state jurisdiction
- Cause of child's death was in utero or traumatic
- Parent age less than 18 years
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 |
|---|---|---|
| ADAPTADAPT, is multi-modal to promote a targeted approach to individual parental bereavement experiences and is not time or geographically limited. ADAPT is based on the theoretical foundations of the Adaptive Leadership (AL) framework. Our interdisciplinary team developed a web-based, multi-modal intervention, labeled ADAPT, that incorporates varied self-management strategies including: A: Asking for assistance (option to connect with child's healthcare team); DA: Developing Adaptive ability (self-management tools: e.g. stress reduction, legacy building); P: Accessing Pertinent online resources (grief support networks/websites); and T: Tracking one's health (self-administered surveys for grief, sleep, anxiety, and depression). Parents can download ADAPT on any digital device (phones/computers) using a Quick Response (QR) bar code or weblink. | Behavioural | Intervention group |
Primary outcome
Recruitment
Time frame: 3 months
Recruited 35 participants in the study timeframe
Retention
Time frame: 3 months
Participants complete surveys at pre and post intervention.
5 secondary outcomes
Sleep
Time frame: 3 months
Grief
Time frame: 3 months
Social isolation
Time frame: 3 months
Anxiety
Time frame: 3 months
Depression
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Nancy Dias, PhD principal investigator
East Carolina University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADAPT in people with Bereavement, run by East Carolina University at 2 sites 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment (time frame: 3 months). 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 22 Mar 2022.