Clinical trial NCT06152549: Online Emotional Response to Completing a Childhood Maltreatment Self-report Scale
Official title: Assessing the Emotional and Physiological Response of Adults to Completing a Self-report Scale on Exposure to Childhood Maltreatment - Online Component
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress, Psychological
Stress, Emotional
Keywords: childhood maltreatment,
adverse childhood experiences
standardized math and verbal tests
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2023-11-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Data will be collected online from participants across the USA. The study will include representative national sample (by age, sex, and ethnicity) of healthy volunteers, from the United States (total N=500) and will be conducted via Prolific™, which maintains a pool of research participants specifically interested in participating in online behavioral or psychological research studies.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Profile of Mood States (POMS)
timeFrame: Through study completion, an average of 90 mins
measure: Total Mood Disturbance (TMD)
timeFrame: Through study completion, an average of 90 mins
Secondary outcomes:
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital through ProlificTM
state: Massachusetts
Study officials:
affiliation: Mclean Hospital
name: Martin H Teicher, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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