Facing Adverse Childhood Experiences

Adverse Childhood Experiences Clinical Trial

— FACE  

Official title:

Facing Adverse Childhood Experiences Using New Technologies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05122988
• Other study ID #: SNF Nr. 100019_197731
• Status: Active, not recruiting
• Start date: October 28, 2021
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: University of Applied Sciences and Arts Northwestern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Childhood experiences affect psychosocial well-being and mental health across the life course for better or worse. The aim of the present study is to investigate how adverse childhood experiences before the age of 18 impact psychological functioning in young adulthood, and whether social information processing and emotion regulation may mediate these associations.

Description:

The study plans to recruit 5000 young adults aged 18 to 21 representative of the German speaking Swiss population. Participant will be invited to the study by mail. Addresses stem from a Swiss sampling registry ("Stichprobenregister SRPH") and are provided by the Swiss Statistical Office. Access to this address lists is reserved to studies of national interest that are funded by the Swiss National Science foundation. Data collection will be conducted online with a REDCap survey following an accelerated cohort design. After the baseline measurement (w1), three follow ups are planned after 1 year (w2), 2 years (w3) and 3 years (w4), resulting in ages 18 to 24 being covered. The primary outcome will be psychosocial functioning across the study period.

1. Primary objective:

The primary objective of the study is to analyse the longitudinal associations between childhood experiences, emotion regulation, social information processing, social support and psychosocial functioning in young adults.

• Hypothese 1 is that adverse childhood experiences (ACE) are associated with a higher risk for lower psychosocial functioning in young adulthood and 2) that this association is mediated by deficits in emotion regulation, social information processing and lower social support.

• Hypothese 2 is that positive childhood experiences are associated with higher social support, adaptive emotion regulation and high well-being in young adulthood and that good relationships with parents and high social support are a protective factor in the presence of adversities.

• Hypothese 3 is that among young adults with ACE, higher social support, seeking professional help and more adaptive coping strategies are associated with a more adaptive psychosocial functioning.

Secondary objectives are

2. to examine the effect of childhood experiences on emotion regulation and social information processing.

3. to investigate the effects of emotion regulation and social information processing on the quality of friendships and social support.

4. to analyse the longitudinal associations of childhood experiences, emotion regulation, social information processing, social support and the single variables that constitute the composite score of psychosocial functioning, e.g. well-being, psychosocial distress, risk behaviours.

5. to investigate the associations between ACE, emotion regulation and social information processing and seeking professional support.

6. Further exploratory hypotheses investigate whether there are patterns of ACE which show differential associations with emotion regulation, social information processing, support and psychosocial functioning or single variables of psychosocial functioning.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2606
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 21 Years

Eligibility

Inclusion Criteria:

• Age 18 to 21, Living in German-speaking Switzerland, Internet Access

Exclusion Criteria:

• Insufficient mastery of German

Related Conditions & MeSH terms

• Adverse Childhood Experiences

Locations

Country	Name	City	State
Switzerland	University of Applied Science Northwestern Switzerland	Olten

Sponsors (1)

Lead Sponsor	Collaborator
University of Applied Sciences and Arts Northwestern Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (15)

Abbott RA, Ploubidis GB, Huppert FA, Kuh D, Croudace TJ. An Evaluation of the Precision of Measurement of Ryff's Psychological Well-Being Scales in a Population Sample. Soc Indic Res. 2010 Jul;97(3):357-373. doi: 10.1007/s11205-009-9506-x. Epub 2009 Sep 1. — View Citation

Berenson KR, Gyurak A, Ayduk O, Downey G, Garner MJ, Mogg K, Bradley BP, Pine DS. Rejection sensitivity and disruption of attention by social threat cues. J Res Pers. 2009 Dec 1;43(6):1064-1072. doi: 10.1016/j.jrp.2009.07.007. — View Citation

Bernstein DP, Stein JA, Newcomb MD, Walker E, Pogge D, Ahluvalia T, Stokes J, Handelsman L, Medrano M, Desmond D, Zule W. Development and validation of a brief screening version of the Childhood Trauma Questionnaire. Child Abuse Negl. 2003 Feb;27(2):169-90. doi: 10.1016/s0145-2134(02)00541-0. — View Citation

Brodbeck J, Matter M, Page J, Moggi F. Motives for cannabis use as a moderator variable of distress among young adults. Addict Behav. 2007 Aug;32(8):1537-45. doi: 10.1016/j.addbeh.2006.11.012. Epub 2006 Dec 18. — View Citation

Dillon KH, Allan NP, Cougle JR, Fincham FD. Measuring Hostile Interpretation Bias: The WSAP-Hostility Scale. Assessment. 2016 Dec;23(6):707-719. doi: 10.1177/1073191115599052. Epub 2015 Aug 6. — View Citation

Ehring T, Zetsche U, Weidacker K, Wahl K, Schonfeld S, Ehlers A. The Perseverative Thinking Questionnaire (PTQ): validation of a content-independent measure of repetitive negative thinking. J Behav Ther Exp Psychiatry. 2011 Jun;42(2):225-32. doi: 10.1016/j.jbtep.2010.12.003. Epub 2010 Dec 21. — View Citation

Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461. — View Citation

Nock MK, Wedig MM, Holmberg EB, Hooley JM. The emotion reactivity scale: development, evaluation, and relation to self-injurious thoughts and behaviors. Behav Ther. 2008 Jun;39(2):107-16. doi: 10.1016/j.beth.2007.05.005. Epub 2007 Oct 29. — View Citation

Norman RE, Byambaa M, De R, Butchart A, Scott J, Vos T. The long-term health consequences of child physical abuse, emotional abuse, and neglect: a systematic review and meta-analysis. PLoS Med. 2012;9(11):e1001349. doi: 10.1371/journal.pmed.1001349. Epub 2012 Nov 27. — View Citation

Pollak SD. Multilevel developmental approaches to understanding the effects of child maltreatment: Recent advances and future challenges. Dev Psychopathol. 2015 Nov;27(4 Pt 2):1387-97. doi: 10.1017/S0954579415000826. — View Citation

Ryff CD, Keyes CL. The structure of psychological well-being revisited. J Pers Soc Psychol. 1995 Oct;69(4):719-27. doi: 10.1037//0022-3514.69.4.719. — View Citation

Schluter MG, Hodgins DC, Wolfe J, Wild TC. Can one simple questionnaire assess substance-related and behavioural addiction problems? Results of a proposed new screener for community epidemiology. Addiction. 2018 Aug;113(8):1528-1537. doi: 10.1111/add.14166. Epub 2018 Feb 26. — View Citation

Silvera DH, Martinussen M, Dahl TI. The Tromso Social Intelligence Scale, a self-report measure of social intelligence. Scand J Psychol. 2001 Sep;42(4):313-9. doi: 10.1111/1467-9450.00242. — View Citation

Spitzer C, Hammer S, Lowe B, Grabe HJ, Barnow S, Rose M, Wingenfeld K, Freyberger HJ, Franke GH. [The short version of the Brief Symptom Inventory (BSI -18): preliminary psychometric properties of the German translation]. Fortschr Neurol Psychiatr. 2011 Sep;79(9):517-23. doi: 10.1055/s-0031-1281602. Epub 2011 Aug 25. German. — View Citation

Weissman DG, Bitran D, Miller AB, Schaefer JD, Sheridan MA, McLaughlin KA. Difficulties with emotion regulation as a transdiagnostic mechanism linking child maltreatment with the emergence of psychopathology. Dev Psychopathol. 2019 Aug;31(3):899-915. doi: 10.1017/S0954579419000348. Epub 2019 Apr 8. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Social information processing: Social Intelligence	Measured with the 14-item Tromsø Social Intelligence Scale (Silvera et al., 2001). The total score ranges from 14 to 98, with a higher score indicating a higher social intelligence.	a baseline measurement (w1)
Other	Social information processing: Social Intelligence	Measured with the 14-item Tromsø Social Intelligence Scale (Silvera et al., 2001). The total score ranges from 14 to 98, with a higher score indicating a higher social intelligence.	change over 3 years (from w1 to w4)
Other	Social information processing: Hostile interpretation bias	Measured with the 32-item Hostile interpretation bias scale (Dillon et al., 2016). The total score for the hostile scale (16 items) ranges from 0 to 96, with a higher score indicating a more hostile interpretation.	a baseline measurement (w1)
Other	Social information processing: Hostile interpretation bias	Measured with the 32-item Hostile interpretation bias scale (Dillon et al., 2016). The total score for the hostile scale (16 items) ranges from 0 to 96, with a higher score indicating a more hostile interpretation.	change over 3 years (from w1 to w4)
Other	Social information processing: Rejection sensitivity	Measured with the 18-item Rejection sensitivity questionnaire (Berenson et al., 2009). The total score ranges from 9 to 54, with a higher score indicating a higher rejection sensitivity.	a baseline measurement (w1)
Other	Social information processing: Rejection sensitivity	Measured with the 18-item Rejection sensitivity questionnaire (Berenson et al., 2009). The total score ranges from 9 to 54, with a higher score indicating a higher rejection sensitivity.	change over 3 years (from w1 to w4)
Other	Emotion regulation: Perseverative Thinking	Measured with the 15-item Perseverative Thinking Questionnaire (Ehring et al., 2011).The total score ranges from 0 to 60, with a higher score indicating more preservative thinking.	a baseline measurement (w1)
Other	Emotion regulation: Perseverative Thinking	Measured with the 15-item Perseverative Thinking Questionnaire (Ehring et al., 2011).The total score ranges from 0 to 60, with a higher score indicating more preservative thinking.	change over 3 years (from w1 to w4)
Other	Emotion regulation: Emotion Reactivity	Measured with the 21-item Emotion Reactivity Scale (Nock et al., 2008). The total score ranges from 0 to 84, with a higher score indicating a higher emotional reactivity.	a baseline measurement (w1)
Other	Emotion regulation: Emotion Reactivity	Measured with the 21-item Emotion Reactivity Scale (Nock et al., 2008). The total score ranges from 0 to 84, with a higher score indicating a higher emotional reactivity.	change over 3 years (from w1 to w4)
Other	Emotion regulation: Self-Efficacy for Managing Emotions	Measured with the 7-item Self-Efficacy for Managing Emotions scale (PROMIS; https://www.healthmeasures.net/explore-measurement-systems/promis). The total score ranges from 7 to 49, with a higher score indicating a better self-efficacy for managing emotions.	a baseline measurement (w1)
Other	Emotion regulation: Self-Efficacy for Managing Emotions	Measured with the 7-item Self-Efficacy for Managing Emotions scale (PROMIS; https://www.healthmeasures.net/explore-measurement-systems/promis). The total score ranges from 7 to 49, with a higher score indicating a better self-efficacy for managing emotions.	change over 3 years (from w1 to w4)
Primary	Latent composite score for psychosocial functioning	A single latent score for overall psychosocial functioning will be created out of the following individual variables using the MPlus software: Well-being (Ryff & Keyes 1995), Internalizing (Spitzer et al., 2011) and externalizing (Renshaw & Cook 2019) psychopathological symptoms, psychosocial burden (Brodbeck et al., 2007) and functioning in social und and work situations (Mundt et al., 2002). A higher score indicates better overall psychological functioning.	a baseline measurement (w1)
Primary	Latent composite score for psychosocial functioning	A single latent score for overall psychosocial functioning will be created out of the following individual variables using the MPlus software: Well-being (Ryff & Keyes 1995), Internalizing (Spitzer et al., 2011) and externalizing (Renshaw & Cook 2019) psychopathological symptoms, psychosocial burden (Brodbeck et al., 2007) and functioning in social und and work situations (Mundt et al., 2002). A higher score indicates better overall psychological functioning.	change over 3 years (from w1 to w4)
Primary	Psychological Well-being	Six dimensions (autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance) measured with Ryffs Well-being scale (Ryff & Keyes 1995), 42 item Version (Abbott et al., 2010). Scores for the subscales range from 7 to 42, and scores for the total scale from 42 to 294. A higher score indicates better well-being.	a baseline measurement (w1)
Primary	Psychological Well-being	Six dimensions (autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance) measured with Ryffs Well-being scale (Ryff & Keyes 1995), 42 item Version (Abbott et al., 2010). Scores for the subscales range from 7 to 42, and scores for the total scale from 42 to 294. A higher score indicates better well-being.	change over 3 years (from w1 to w4)
Primary	Internalizing symptoms	Measured with the 18-item Brief Symptom Inventory (BSI-18) (Spitzer et al., 2011), containing questions about depressivity, anxiety and somatic symptoms. The total score ranges from 18 to 90, and a higher score indicates more internalizing symptoms.	a baseline measurement (w1)
Primary	Internalizing symptoms	Measured with the 18-item Brief Symptom Inventory (BSI-18) (Spitzer et al., 2011), containing questions about depressivity, anxiety and somatic symptoms. The total score ranges from 18 to 90, and a higher score indicates more internalizing symptoms.	change over 3 years (from w1 to w4)
Primary	Externalizing symptoms	Measured with the 10-item Externalizing Problems Screener (Renshaw & Cook 2019). Total score ranges from 0 to 40, with a higher score indicating more externalizing symptoms.	a baseline measurement (w1)
Primary	Externalizing symptoms	Measured with the 10-item Externalizing Problems Screener (Renshaw & Cook 2019). Total score ranges from 0 to 40, with a higher score indicating more externalizing symptoms.	change over 3 years (from w1 to w4)
Primary	Functioning in social und and work situations	Measured with the 5-item Work and Social Adjustment Scale (Mundt et al., 2002), measuring impairment in different social and work situations. The total score ranges from 0 to 40, with a higher score indicating worse functioning in social and work situations.	a baseline measurement (w1)
Primary	Functioning in social und and work situations	Measured with the 5-item Work and Social Adjustment Scale (Mundt et al., 2002), measuring impairment in different social and work situations. The total score ranges from 0 to 40, with a higher score indicating worse functioning in social and work situations.	change over 3 years (from w1 to w4)
Secondary	Help seeking behaviour	We asked whether participants ever sought professional help due to psychological and social problems. If yes, we asked about whether they sought help in eight different types of support setting (e.g. psychotherapy, general practitioner, psychological service at school).	a baseline measurement (w1)
Secondary	Help seeking behaviour	We asked whether participants ever sought professional help due to psychological and social problems. If yes, we asked about whether they sought help in eight different types of support setting (e.g. psychotherapy, general practitioner, psychological service at school).	change over 3 years (from w1 to w4)
Secondary	Social Support	Measured with the 14-Item social support scale (Fydrich et al., 2009). The total score ranges from 14 to 70, with a higher score indicating better social support.	a baseline measurement (w1)
Secondary	Social Support	Measured with the 14-Item social support scale (Fydrich et al., 2009). The total score ranges from 14 to 70, with a higher score indicating better social support.	change over 3 years (from w1 to w4)
Secondary	Substance use	Participants were asked how frequently they used tobacco, alcohol, cannabis, party drugs, cocaine/heroin, other drugs and pharmaceutical drugs for non-medical use. For substances they used, they were additionally asked the age of first use and the 4-item Addiction Screener (Schluter et al., 2018). The total score for the addiction screener ranges from 0 to 16, with a higher score indicating worse outcomes.	a baseline measurement (w1)
Secondary	Substance use	Participants were asked how frequently they used tobacco, alcohol, cannabis, party drugs, cocaine/heroin, other drugs and pharmaceutical drugs for non-medical use. For substances they used, they were additionally asked the age of first use and the 4-item Addiction Screener (Schluter et al., 2018). The total score for the addiction screener ranges from 0 to 16, with a higher score indicating worse outcomes.	change over 3 years (from w1 to w4)
Secondary	Psychosocial Burden	Participants were asked to which degree they felt burdened in 13 different areas of life, for example school/work, sleep, romantic relationship, physical health, financial situation (Brodbeck et al., 2007). The total score ranges from 0 to 130, with a higher score indicating more burden.	a baseline measurement (w1)
Secondary	Psychosocial Burden	Participants were asked to which degree they felt burdened in 13 different areas of life, for example school/work, sleep, romantic relationship, physical health, financial situation (Brodbeck et al., 2007). The total score ranges from 0 to 130, with a higher score indicating more burden.	change over 3 years (from w1 to w4)