Stigma of Parents of Children With Mental Illness Clinical Trial
— STCOfficial title:
Starting the Conversation (STC) - Web-based Group Intervention to Support Disclosure Decisions for Parents of Children With Mental Illness
| NCT number | NCT04107714 |
| Other study ID # | 375/18 |
| Secondary ID | |
| Status | Terminated |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | October 1, 2019 |
| Est. completion date | May 1, 2021 |
| Verified date | May 2021 |
| Source | University of Ulm |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is to evaluate the group-based intervention "Starting the Conversation" as a webinar in Germany. Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial (RCT).
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | May 1, 2021 |
| Est. primary completion date | February 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Parent with at least one child or adolescent that (i) is aged between 6 to 17 years (ii) has a current mental disorder according to ICD-10 diagnosed by a psychiatrist or psychologist - Age = 18 years - Positive screening for disclosure distress (1 item: "In general, how distressed or worried are you in terms of secrecy or disclosure of the mental illness of your child?", self-report, persons with a score = 4 on a scale from 1-7 were included) - Online informed consent - Sufficient German language skills Exclusion Criteria: - Intellectual disability of child (IQ<70, self-report) |
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Child and Adolescent Psychiatry, University of Ulm | Ulm |
| Lead Sponsor | Collaborator |
|---|---|
| University of Ulm |
Germany,
Angermeyer MC, Kilian R, Matschinger H. WHOQOL-100 und WHOQOL-BREF: Handbuch für die deutschsprachigen Versionen der WHO Instrumente zur Erfassung von Lebensqualität [WHOQOL-100 and WHOQOL-BREF: Handbook for the German version of WHO instruments to assess quality of life]. Göttingen: Hogrefe; 2000.
Eaton K, Ohan JL, Stritzke WGK, Corrigan PW. The Parents' Self-Stigma Scale: Development, Factor Analysis, Reliability, and Validity. Child Psychiatry Hum Dev. 2019 Feb;50(1):83-94. doi: 10.1007/s10578-018-0822-8. — View Citation
Hacking S, Secker J, Spandler H, Kent L, Shenton J. Evaluating the impact of participatory art projects for people with mental health needs. Health Soc Care Community. 2008 Dec;16(6):638-48. doi: 10.1111/j.1365-2524.2008.00789.x. Epub 2008 May 13. — View Citation
Kliem S, Mößle T, Rehbein F, Hellmann DF, Zenger M, Brähler E. A brief form of the Perceived Social Support Questionnaire (F-SozU) was developed, validated, and standardized. J Clin Epidemiol. 2015 May;68(5):551-62. doi: 10.1016/j.jclinepi.2014.11.003. Epub 2014 Nov 13. — View Citation
Morris E, Hippman C, Murray G, Michalak EE, Boyd JE, Livingston J, Inglis A, Carrion P, Austin J. Self-Stigma in Relatives of people with Mental Illness scale: development and validation. Br J Psychiatry. 2018 Mar;212(3):169-174. doi: 10.1192/bjp.2017.23. Epub 2018 Feb 5. — View Citation
Rüsch N, Corrigan PW, Powell K, Rajah A, Olschewski M, Wilkniss S, Batia K. A stress-coping model of mental illness stigma: II. Emotional stress responses, coping behavior and outcome. Schizophr Res. 2009 May;110(1-3):65-71. doi: 10.1016/j.schres.2009.01.005. Epub 2009 Feb 23. — View Citation
Rüsch N, Corrigan PW, Wassel A, Michaels P, Olschewski M, Wilkniss S, Batia K. A stress-coping model of mental illness stigma: I. Predictors of cognitive stress appraisal. Schizophr Res. 2009 May;110(1-3):59-64. doi: 10.1016/j.schres.2009.01.006. Epub 2009 Mar 6. — View Citation
Secker J, Hacking S, Kent L, Shenton J, Spandler H. Development of a measure of social inclusion for arts and mental health project participants. Journal of Mental Health. 2009;18(1):65-72. doi:10.1080/09638230701677803
The KIDSCREEN Group Europe. The Kidscreen questionnaires: Quality of life questionnaires for children and adolescents: handbook. Lengerich: Pabst Science Publishers; 2006.
Tröster H. Eltern-Belastungs-Inventar: Deutsche Version des Parenting Stress Index (PSI) von R. R. Abidin [German version of Parenting Stress Index of R. R. Abidin]. Göttingen: Hogrefe; 2011.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Self-stigma of parents | Parent's Self-Stigma Scale (PSSS) (Eaton et al., 2018), 11 items rated from 1 to 5, sum score (range 5-55) with higher scores indicating more self-stigma. | 8 weeks | |
| Secondary | Self-stigma of parents | Parent's Self-Stigma Scale (PSSS) (Eaton et al., 2018), 11 items rated from 1 to 5, sum score (range 5-55) with higher scores indicating more self-stigma. | baseline, 4 weeks, 16 weeks | |
| Secondary | Self-stigma of parents | Self-Stigma in Relatives of People with Mental Illness Scale (SSRMI) (Morris et al., 2018), 10 items rated from 1 to 5, mean score across all items (range 1-5) with higher scores indicating more self-stigma. | baseline, 4 weeks, 8 weeks, 16 weeks | |
| Secondary | Stigma stress related to child's mental illness | Stigma Stress Scale (Rüsch et al., 2009a,b) adapted for parents of children with mental illness, 8 items rated from 1 to 7 with 4 items measuring the primary appraisal of stigma as harmful and 4 items measuring the secondary appraisal of perceived resources to cope with stigma-related harm, for each of the two subscales there is a mean score (range 1-7), and a total stigma stress score will be calculated by subtracting perceived resources from perceived harm with higher difference scores (range -6 to +6) indicating more stigma stress. | baseline, 4 weeks, 8 weeks, 16 weeks | |
| Secondary | Parenting distress | Parenting Stress Index, parent domain (PSI) (Tröster, 2011), 28 items rated from 1 to 5, sum scores of subscales (range 4-20) and across all items (range 28-140) with higher scores indicating more parenting distress. | baseline, 4 weeks, 8 weeks, 16 weeks | |
| Secondary | Quality of life of parents | World Health Organization Quality of Life Assessment-short form (WHOQOL-BREF), domains general quality of life, psychological and social relationships (Angermeyer, Kilian & Matschinger, 2000), 11 items rated from 1 to 5, mean scores of each domain (range 1-5) with higher scores indicating better quality of life. | baseline, 4 weeks, 8 weeks, 16 weeks | |
| Secondary | Parent-rated child quality of life | KIDSCREEN-10, parent version (The KIDSCREEN Group Europe, 2006), 10 items rated from 1 to 5, sum score across all items (range 5-50) with higher scores indicating better child quality of life. | baseline, 4 weeks, 8 weeks, 16 weeks | |
| Secondary | Self-esteem | Rosenberg Self-Esteem Scale (RSE) (Collani & Herzberg, 2003), 10 items rated from 0 to 3, sum score across all items (range 0-30) with higher scores indicating higher self-esteem. | baseline, 4 weeks, 8 weeks, 16 weeks | |
| Secondary | Social support | Perceived Social Support Questionnaire (FsozU K-6) (Kliem et al., 2015), 6 items rated from 1 to 5, mean score across all items (range 1-5) with higher scores indicating more perceived social support. | baseline, 4 weeks, 8 weeks, 16 weeks | |
| Secondary | Social inclusion | Social Inclusion Scale (SIS) (Hacking et al., 2008; Secker et al., 2009) adapted for parents of children with mental illness, 20 items rated from 1 to 4, mean scores (range 1-4) of subscales and across all items with higher scores indicating higher social inclusion. | baseline, 4 weeks, 8 weeks, 16 weeks |