Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-31 @ 8:50 PM
Study NCT ID:
NCT04929405
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2020-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Testing ADAPT a Bereavement Care Intervention
Sponsor:
East Carolina University
Organization:
Study Overview
Official Title:
Pilot-Testing a Theoretically Based Digital Intervention for Bereaved Parents (ADAPT)
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAPT
Brief 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 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.
B. 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.
B. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: