CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 500 enrolled
Drug / intervention
Maltreatment and Abuse Chronology of Exposure Scale as a stress challenge +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT06152549
NCT06152549N/ACompleted

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

Mclean Hospital·observational·Posted Nov 30, 2023·Updated Mar 13, 2024

In Brief

An observational study evaluating Maltreatment and Abuse Chronology of Exposure Scale as a stress challenge, Standardized Maths and Verbal Questions such as the ones used in SATs, and 2 other interventions for Stress, Psychological and Stress, Emotional. Completed, enrolled 500 participants across 1 site.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedNov 30, 2023
Enrollment StartOct 15, 2022
Primary CompletionDec 15, 2023
Study CompletionDec 30, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 2.6 years ago

Interventions

Maltreatment and Abuse Chronology of Exposure Scale as a stress challengebehavioral

The 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.

Standardized Maths and Verbal Questions such as the ones used in SATsbehavioral

The 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.

Chronology of Perceived Discrimination Scale (CPDS)behavioral

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.

International Personality Item Pool (IPIP-NEO)behavioral

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.