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Completed

NCT Number: NCT06152549

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

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McLean Hospital through ProlificTM

Belmont, Massachusetts, 02478, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers ages 18-65, living full-time in the U.S at the time of participation in the study.

Exclusion criteria

  • Below 18 or above 65. Living outside the U.S at the time of participation in the study.

Treatment and study plan

Maltreatment and Abuse Chronology of Exposure Scale as a stress challenge

Behavioral

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 SATs

Behavioral

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.

Primary outcomes

  1. Profile of Mood States (POMS)

    Time frame: Through study completion, an average of 90 mins

    The abbreviated form of the POMS(40-items) provides ratings of anger-hostility, confusion-bewilderment, depression-dejection, fatigue-inertia, tension-anxiety, vigor-activity, friendliness and a total mood disturbance score. It takes only 3-5 minutes to complete. Items are scored as Not at all(0), A little(1), Moderately(2), Quite a lot(3), Extremely(4). Scores for the seven subscales in the abbreviated POMS are calculated by summing the numerical ratings for items that contribute to each subscale, with two items "Ashamed" and "Embarrassed" reverse scored.

  2. Total Mood Disturbance (TMD)

    Time frame: Through study completion, an average of 90 mins

    Total Mood Disturbance (TMD) is calculated by summing the totals for the POMS negative subscales and then subtracting the totals for the POMS positive subscales.

    The formula is as follows:

    TMD = [Tension+Depression+Anger+Fatigue+Confusion] - [Vigor+Esteem-related Affect]

Sponsors and collaborators

Lead sponsor

Mclean Hospital

Other

Registry information

Official study title

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

Acronym: MACEStress

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 30, 2023
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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