Clinical Trials Directory

Trials / Completed

CompletedNCT06152549

Online Emotional Response to Completing a Childhood Maltreatment Self-report Scale

Assessing the Emotional and Physiological Response of Adults to Completing a Self-report Scale on Exposure to Childhood Maltreatment - Online Component

Status
Completed
Phase
Study type
Observational
Enrollment
500 (actual)
Sponsor
Mclean Hospital · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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 N=500, 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 Math/Verbal 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMaltreatment and Abuse Chronology of Exposure Scale as a stress challengeThe first group (N=250) will receive the Maltreatment and Abuse Chronology of Exposure (MACE) scale first, to assess early life adversity, followed by the standardized test questions. A POMS will be administered before each challenge.
BEHAVIORALStandardized Maths and Verbal Questions such as the ones used in SATsThe second group (N=250) will be presented with the standardized test questions (Math/Verbal) to assess their stress level, measured through POMS, followed by the Maltreatment and Abuse Chronology of Exposure (MACE) scale.
BEHAVIORALChronology of Perceived Discrimination Scale (CPDS)The group will also receive the Chronology of Perceived Discrimination Scale (CPDS) to assess type and timing of perceived discrimination during the first 18 years of life. A POMS will be administered before and after the intervention/challenge.
BEHAVIORALInternational Personality Item Pool (IPIP-NEO)Participants in both groups will be presented with the abbreviated version of the IPIP-NEO a personality questionnaire that provides ratings on the Five Factor Personality Model. The research team sees this task as non-stressful and even potentially soothing and envisions that it will help to restore an individual's mood before taking the next stressful test and again at the completion of the online session.

Timeline

Start date
2022-10-15
Primary completion
2023-12-15
Completion
2023-12-30
First posted
2023-11-30
Last updated
2024-03-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06152549. Inclusion in this directory is not an endorsement.