Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152549
Status:
COMPLETED
Last Update Posted:
2024-03-13
First Post:
2022-12-07
Brief Title:
Online Emotional Response to Completing a Childhood Maltreatment Self-report Scale
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
Official Title:
Assessing the Emotional and Physiological Response of Adults to Completing a Self-report Scale on Exposure to Childhood Maltreatment - Online Component
Status:
COMPLETED
Status Verified Date:
2024-03
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:
MACEStress
Brief Summary:
Childhood adversity in the form of maltreatment and household dysfunction is the most important risk factor for psychopathology as well as a major risk factor for a host of medical disorders It has been estimated that adverse childhood experiences account for 45 50 64 and 67 of the population attributable risk for childhood onset psychiatric disorders alcoholism depression substance abuse and suicide attempts There is also increasing evidence that maltreated and non-maltreated individuals with the same primary psychiatric diagnosis are clinically and neurobiologically distinct and respond differently to treatment The investigators and others have proposed that assessment of exposure to maltreatment is imperative for prevention targeted treatment and research A potential barrier to the widespread collection of data regarding early life stress and childhood maltreatment is the concern that asking such probing questions particularly on an online questionnaire may provoke untoward reactions and create clinical problems
Therefore the investigators have designed this observational study to test our hypothesis that answering questions about type and timing of childhood maltreatment are no more stressful than answering standardized mathematical and verbal questions of the type asked on the Scholastic Aptitude Test SAT
The study will include representative national samples by age sex and ethnicity from the United States total N500 Ages 18-65 and will be conducted online via Prolific which maintains a pool of research participants
Participants will be assigned randomly to one of two test sequences
In sequence 1 the Maltreatment and Abuse Chronology of Exposure MACE scale will be presented toward the beginning of the session and the MathVerbal Test toward the end
In sequence 2 the order will be reversed
The impact of completing the MACE and standardized IQ questions will be assessed before and after each module using the abbreviated form of the Profile of Mood States POMS
Therefore the investigators have designed this observational study to test our hypothesis that answering questions about type and timing of childhood maltreatment are no more stressful than answering standardized mathematical and verbal questions of the type asked on the Scholastic Aptitude Test SAT
The study will include representative national samples by age sex and ethnicity from the United States total N500 Ages 18-65 and will be conducted online via Prolific which maintains a pool of research participants
Participants will be assigned randomly to one of two test sequences
In sequence 1 the Maltreatment and Abuse Chronology of Exposure MACE scale will be presented toward the beginning of the session and the MathVerbal Test toward the end
In sequence 2 the order will be reversed
The impact of completing the MACE and standardized IQ questions will be assessed before and after each module using the abbreviated form of the Profile of Mood States POMS
Detailed Description:
Childhood adversity in the form of maltreatment and household dysfunction is the most important risk factor for psychopathology as well as a major risk factor for a host of medical disorders Briefly it has been estimated that adverse childhood experiences account for 45 50 54 64 and 67 of the population attributable risk for childhood onset psychiatric disorders alcoholism depression substance abuse and suicide attempts respectively Maltreatment is also associated with increased risk for heart disease cancer chronic lung disease liver disease and shortened life span There is increasing evidence that maltreated and non-maltreated individuals with the same primary psychiatric diagnosis are clinically and neurobiologically distinct and respond differentially to treatment Hence the investigators and others have proposed that assessment of exposure to maltreatment is imperative for prevention targeted treatment and research
However a potential barrier to widespread collection of data regarding early life stress and childhood maltreatment is the concern that asking such probing questions particularly on an online questionnaire may provoke untoward reactions and create clinical problems To date the investigators have collected maltreatment data on over 3000 participants without a single call from participants about feeling distressed While some IRBs permit collection of this information online the investigators are aware of colleagues at other universities who have had their request denied
Our thought is that whatever human subjects limitations should be imposed on collecting childhood maltreatment data via self-report should not simply be a matter of opinion but should be based on evidence
Hence the investigators are proposing to specifically study the acute emotional response of volunteer participants especially those with a history of self-reported childhood maltreatment to completing a detailed self-report instrument on type and timing of exposure to childhood maltreatment For contrast the investigators will also compare their response to completing a series of mathematical and verbal questions of the type asked on the Scholastic Aptitude Test SAT as an example of the type of questions that can be asked without human subject approval
Our primary hypothesis is that endeavoring to answer these questions will be more stressful and emotionally provocative than questions regarding history of childhood maltreatment even in participants who report moderate-to-high levels of childhood maltreatment
However a potential barrier to widespread collection of data regarding early life stress and childhood maltreatment is the concern that asking such probing questions particularly on an online questionnaire may provoke untoward reactions and create clinical problems To date the investigators have collected maltreatment data on over 3000 participants without a single call from participants about feeling distressed While some IRBs permit collection of this information online the investigators are aware of colleagues at other universities who have had their request denied
Our thought is that whatever human subjects limitations should be imposed on collecting childhood maltreatment data via self-report should not simply be a matter of opinion but should be based on evidence
Hence the investigators are proposing to specifically study the acute emotional response of volunteer participants especially those with a history of self-reported childhood maltreatment to completing a detailed self-report instrument on type and timing of exposure to childhood maltreatment For contrast the investigators will also compare their response to completing a series of mathematical and verbal questions of the type asked on the Scholastic Aptitude Test SAT as an example of the type of questions that can be asked without human subject approval
Our primary hypothesis is that endeavoring to answer these questions will be more stressful and emotionally provocative than questions regarding history of childhood maltreatment even in participants who report moderate-to-high levels of childhood maltreatment
Study Oversight
Has Oversight DMC:
None
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?:
None