Adverse Childhood Experiences Clinical Trial
Official title:
Fostering Resilience and Well-being in Young Adults With a History of Adverse Childhood Experiences - the FACE Self-help App
The FACE self-help app is an online intervention for young adults with Adverse Childhood Experiences (ACEs). It was developed based on well-established cognitive-behavioural therapy principles. The self-help app contains two components, one targeting emotion regulation (ER), the other social information processing (SIP).
Status | Recruiting |
Enrollment | 350 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 25 Years |
Eligibility | Inclusion Criteria: - Self-reported ACEs - An informed consent - The possession of a smartphone - Mastery of the German language. - Age between 18 and 25 Exclusion Criteria: - Inability to follow the procedures of the study, e.g., due to comprehension problems, visual impairment, lack of sufficient motor skills or severe psychological or somatic disorders which require immediate treatment which impedes the continuous work on the self-help programme. These points will be discussed with the participant in the screening telephone call. - Acute suicidality. |
Country | Name | City | State |
---|---|---|---|
Switzerland | University of Applied Sciences and Arts Northwestern Switzerland | Olten | Solothurn |
Lead Sponsor | Collaborator |
---|---|
Jeannette Brodbeck | University of Bern |
Switzerland,
Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113. — View Citation
D'Zurilla, T. J., Nezu, A. M., & Maydeu-Olivares, A. (2002). Social problem-solving inventory-revised: Technical manual. North Tonawanda, NY: Multi-Health Systems, 475.
Daros, A. R., Daniel, K. E., Meyer, M. J., Chow, P. I., Barnes, L. E., & Teachman, B. A. (2019). Impact of social anxiety and social context on college students' emotion regulation strategy use: An experience sampling study. Motivation and Emotion, 43(5), 844-855. https://doi.org/10.1007/s11031-019-09773-x
Graf, A. (2003). Psychometrische Überprüfung einer deutschsprachigen Übersetzung des SPSI-R. Zeitschrift für Differentielle und Diagnostische Psychologie, 24(4), 277-291. https://doi.org/10.1024/0170-1789.24.4.277
Grosse Holtforth, M., & Grawe, K. (2003). Der Inkongruenzfragebogen (INK). Zeitschrift für Klinische Psychologie und Psychotherapie, 32(4), 315-323. https://doi.org/10.1026/0084-5345.32.4.315
Kemper, C. J., Lutz, J., & Neuser, J. (2012). Konstruktion und Validierung einer Kurzform der Skala Angst vor negativer Bewertung (SANB-5). Klinische Diagnostik und Evaluation, 4, 343-360.
Oorschot M, Lataster T, Thewissen V, Lardinois M, Wichers M, van Os J, Delespaul P, Myin-Germeys I. Emotional experience in negative symptoms of schizophrenia--no evidence for a generalized hedonic deficit. Schizophr Bull. 2013 Jan;39(1):217-25. doi: 10.1093/schbul/sbr137. Epub 2011 Oct 20. — View Citation
PROMIS. (2022). https://www.healthmeasures.net/explore-measurement-systems/promis
Rosenberg, M. (1965). Society and the adolescent self-image. Princeton university press.
Röthlin, P., Holtforth, M. G., Bergomi, C., Berking, M., Ottenbreit, N. D., & Caspar, F. (2010). Vermeidung und depression. Diagnostica.
Sarubin, N., Gutt, D., Giegling, I., Bühner, M., Hilbert, S., Krähenmann, O., Wolf, M., Jobst, A., Sabaß, L., Rujescu, D., Falkai, P., & Padberg, F. (2015). Erste Analyse der psychometrischen Eigenschaften und Struktur der deutschsprachigen 10- und 25-Item Version der Connor-Davidson Resilience Scale (CD-RISC). Zeitschrift für Gesundheitspsychologie, 23(3), 112-122. https://doi.org/10.1026/0943-8149/a000142
Schick M, Schonbucher V, Landolt MA, Schnyder U, Xu W, Maier T, Mohler-Kuo M. Child Maltreatment and Migration: A Population-Based Study Among Immigrant and Native Adolescents in Switzerland. Child Maltreat. 2016 Feb;21(1):3-15. doi: 10.1177/1077559515617019. Epub 2015 Nov 19. — View Citation
Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63. — View Citation
Vormbrock, F., & Neuser, J. (1983). Konstruktion zweier spezifischer Trait-Fragebogen zur Erfassung von Angst in sozialen Situationen (SANB und SVSS). Diagnostica, 29(2), 165-182.
Watson D, Friend R. Measurement of social-evaluative anxiety. J Consult Clin Psychol. 1969 Aug;33(4):448-57. doi: 10.1037/h0027806. No abstract available. — View Citation
Wichers M, Peeters F, Rutten BP, Jacobs N, Derom C, Thiery E, Delespaul P, van Os J. A time-lagged momentary assessment study on daily life physical activity and affect. Health Psychol. 2012 Mar;31(2):135-44. doi: 10.1037/a0025688. Epub 2011 Oct 10. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Participant satisfaction | The ZUF-8 is a self-report measure that explores patients' overall satisfaction with the treatment (Schmidt et al., 1989). For this study, the instrument was adapted to explore patients' satisfaction with the Internet intervention studied in this trial. The scale contains eight items that are rated on a 4-point scale from 1 - low satisfaction to 4 - high satisfaction. A higher score indicates more satisfaction with the online intervention. The German version of the ZUF-8 showed adequate psychometric properties with good internal consistency, construct validity, and concurrent validity (Schmidt et al., 1989). | at week 13, t2 (post-measurement) | |
Other | Momentary affect | The scale is an abbreviated version of the PANAS following previous research, that used similar EMA items (Oorschot et al., 2013; Wichers et al., 2012). | three one week periods with 6 measurements a day (t0, t1, t2) | |
Other | Momentary coping | The items of the coping scale were developed by this research team on the basis of previous research (Daros et al., 2019). They measure different emotion regulation and coping strategies such as reappraisal, avoidance or changing the situation. | three one week periods with 6 measurements a day (t0, t1, t2) | |
Other | Momentary burden | These items were developed by this research team as an addition to the emotion regulation items based on feedback from a user testing group. The participants indicate how burdened they feel in different areas.The scale contains 6 items (school/work, family, friends, feelings/thoughts, difficult memories, leisure time) that are rated on a 7-point scale from 0 - not at all to 6 - extremely. Furthermore, participants can indicate burdens in other areas. | three one week periods with 6 measurements a day (t0, t1, t2) | |
Other | Momentary social interactions | These items were developed by this research team. The Items explore the participants emotional state in the last social situation, for example how happy a person felt in the interaction.
First, participants are asked, if they had a social interaction since the last measurement. If participants indicate an interaction, there are 7 follow-up questions about how the participant felt in this interaction. The scale contains 7 items (stressed, well, anxious, understood, irritated, insecure, happy) that are rated on a 7-point scale from 0 - not at all to 6 - extremely. |
three one week periods with 6 measurements a day (t0, t1, t2) | |
Primary | Resilience | Resilience will be assessed with the German version (Sarubin et al., 2015) of the Connor-Davidson Resilience Scale (CD-RISC) (Connor & Davidson, 2003). The scale contains 10 items that are rated on a 5-point scale from 0 - Not true at all to 4 - True nearly all the time. A higher score indicates more resilience. | at week 13, t2 (post-measurement) | |
Secondary | Well-being | Well-being will be assessed with the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (Tennant et al., 2007). The scale contains 14 items that are rated on a 5-point scale from 1 - never to 5 - always. A higher score indicates better well-being. | at week 13, t2 (post-measurement) | |
Secondary | Emotion Regulation | Self-Efficacy for Managing Emotions will be assessed with the PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions (PROMIS, 2022). The scale contains 7 items that are rated on a 5-point scale from 1 - never to 5 - always. A higher score indicates better emotion regulation skills. | at week 13, t2 (post-measurement) | |
Secondary | Fear of Negative Evaluation | Fear of Negative Evaluation will be assessed with the German short version of the fear of Negative Evaluation Scale (SANB-5) (Kemper et al., 2012). The scale contains 5 items that are rated on a 4-point likert scale from 1 - almost never true to 4- almost always true. A higher score indicates more fear of negative evaluation. | at week 13, t2 (post-measurement) | |
Secondary | Social Avoidance | Social avoidance will be assessed with the subscale social-behavioral avoidance from the German version of the cognitive-behavioral avoidance scale (KBVS) (Röthlin et al., 2010). The subscale contains 8 items that are rated on a 5-point likert scale from 1 - not at all applicable for me to 5 - absolutely applicable for me. A higher score indicates more social avoidance. | at week 13, t2 (post-measurement) | |
Secondary | Problem-Solving | Problem-solving will be assessed with German version (Graf, 2003) of the short form of the Social Problem-Solving Inventory-Revised (SPSI-R) (D'Zurilla et al., 2002).The scale contains 25 items that are rated on a 5-point scale from 0 - not at all true to 4 - extremely true. The scale contains 5 subscales: positive problem orientation, negative problem orientation, rational problem-solving, impulsive style, avoidance style. A higher score indicates a higher orientation on each subscale. | at week 13, t2 (post-measurement) | |
Secondary | Self-Esteem | Self-esteem will be assessed with the German version (Collani & Herzberg, 2003) of the Rosenberg Self-Esteem Scale (Rosenberg, 1965). The scale contains 10 items that are rated on a 4-point scale from 1 - not at all true to 4 - extremely true. A higher score indicates more self-esteem. | at week 13, t2 (post-measurement) | |
Secondary | Stability of improvement in well-being | Well-being will be assessed with the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) (Tennant et al., 2007). The scale contains 14 items that are rated on a 5-point scale from 1 - never to 4 - always. A higher score indicates better well-being. | at week 24, t4 (follow-up) | |
Secondary | Stability of improvement in emotion regulation | Self-Efficacy for Managing Emotions will be assessed with the PROMIS Short Form v1.0 - Self-Efficacy for Managing Emotions (PROMIS, 2022). The scale contains 7 items that are rated on a 5-point scale from 1 - never to 5 - always. A higher score indicates better emotion regulation skills. | at week 24, t4 (follow-up) | |
Secondary | Stability of decrease in fear of negative evaluation | Fear of Negative Evaluation will be assessed with the German short version of the fear of Negative Evaluation Scale (SANB-5) (Kemper et al., 2012). The scale contains 5 items that are rated on a 4-point likert scale from 1 - almost never true to 4- almost always true. A higher score indicates more fear of negative evaluation. | at week 24, t4 (follow-up) | |
Secondary | Stability of decrease in social avoidance | Social avoidance will be assessed with the subscale social-behavioral avoidance from the German version of the cognitive-behavioral avoidance scale (KBVS) (Röthlin et al., 2010). The subscale contains 8 items that are rated on a 5-point likert scale from 1 - not at all applicable for me to 5 - absolutely applicable for me. A higher score indicates more social avoidance. | at week 24, t4 (follow-up) | |
Secondary | Stability of improvement in problem-solving | Problem-solving will be assessed with German version (Graf, 2003) of the short form of the Social Problem-Solving Inventory-Revised (SPSI-R) (D'Zurilla et al., 2002). The scale contains 25 items that are rated on a 5-point scale from 0 - not at all true to 4 - extremely true. The scale contains 5 subscales: positive problem orientation, negative problem orientation, rational problem-solving, impulsive style, avoidance style. A higher score indicates a higher orientation on each subscale. | at week 24, t4 (follow-up) | |
Secondary | Stability of improvement in self-esteem | Self-esteem will be assessed with the German version (Collani & Herzberg, 2003) of the Rosenberg Self-Esteem Scale (Rosenberg, 1965). The scale contains 10 items that are rated on a 4-point scale from 1 - not at all true to 4 - extremely true. A higher score indicates more self-esteem. | at week 24, t4 (follow-up) | |
Secondary | Stability of improvement in resilience | Resilience will be assessed with the German version (Sarubin et al., 2015) of the Connor-Davidson Resilience Scale (CD-RISC) (Connor & Davidson, 2003). The scale contains 10 items that are rated on a 5-point scale from 0 - Not true at all to 4 - True nearly all the time. A higher score indicates more resilience. | at week 24, t4 (follow-up) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04961177 -
Increasing Use of Earned Income Tax Credit (EITC) in New Mexico
|
N/A | |
Recruiting |
NCT04752228 -
Adverse Childhood Experiences in Patients With Coronary Artery Disease Pilot
|
N/A | |
Completed |
NCT05129501 -
The Impact of an Adapted Version of the Strengthening Families Program on IPV Among Caregivers and ACEs Among Children
|
N/A | |
Completed |
NCT05567250 -
Testing a Scalable Model For ACEs-Related Care Navigation
|
N/A | |
Completed |
NCT04100577 -
Today Not Tomorrow Pregnancy and Infant Support Program (TNT- PISP)
|
N/A | |
Active, not recruiting |
NCT05122988 -
Facing Adverse Childhood Experiences
|
||
Recruiting |
NCT05611060 -
Evaluation of the Building Healthy Life Skills Program
|
Phase 2 | |
Recruiting |
NCT06236100 -
Evaluating an Adverse Childhood Experience-Targeting Advocate Model of a Substance Use Prevention Program
|
N/A | |
Recruiting |
NCT05972265 -
Childhood Trauma, Exercise, and Cognition
|
N/A | |
Recruiting |
NCT05388864 -
Building Resilient Families
|
N/A | |
Not yet recruiting |
NCT06153316 -
School Violence Exposure as an Adverse Childhood Experience
|
||
Recruiting |
NCT04719897 -
Life Experiences in Adolescents and the Development of Skills
|
N/A | |
Not yet recruiting |
NCT05377372 -
Early Life Exposures Among Children With Sickle Cell Disease
|
N/A | |
Recruiting |
NCT06454344 -
The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies
|
N/A | |
Completed |
NCT04096937 -
Journey of Hope in Appalachia: Supporting Resilience in the Region's Youth
|
||
Not yet recruiting |
NCT03836456 -
Approaches That Support Mental Health in Post-secondary Students With Adverse Childhood Experiences
|
N/A | |
Completed |
NCT06127693 -
Childhood Adversity, Inflammatory Reactivity and Persistent Pain
|
||
Recruiting |
NCT05973123 -
BLOOM: Boldly Living outdOOrs for Mental Health
|
N/A | |
Not yet recruiting |
NCT04018404 -
Family Resilience Initiative Research Program
|
N/A | |
Terminated |
NCT04922710 -
Physical Exercise for Augmenting Cognitive Health (PEACH)
|
Early Phase 1 |