Stigma of Parents of Children With Mental IllnessPhase 2STCNCT04107714
Starting the Conversation
A Phase 2 study testing STC in people with Stigma of Parents of Children With Mental Illness, run by University of Ulm at 1 site in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stigma of Parents of Children With Mental Illness
- What is being tested?
- STC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2019to 1 May 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Intellectual disability of child (IQ<70, self-report)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Child and Adolescent Psychiatry, University of Ulm
Ulm, 89073
About this study
Official title: Starting the Conversation (STC) - Web-based Group Intervention to Support Disclosure Decisions for Parents of Children With Mental Illness
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).
Read the detailed description
Parents of children with mental illness often experience public and self-stigma, and keeping a child's mental illness secret is a common strategy to avoid stigma. Both secrecy and disclosure have pros and cons for parents and their children. Therefore, the decision whether, when, and to whom to disclose a child's mental illness is complex. Interventions can provide guidance for systematic consideration and a well informed decision.
The manualized peer-led group intervention "Honest, Open, Proud" (HOP) supports people with mental illness in their decision whether to disclose mental illness. Research showed positive effects of the intervention on stigma stress, disclosure-related distress and quality of life. Based on HOP, "Starting the Conversation" (STC) was developed to systematically guide parents through their decision whether and how to disclose a child's mental illness.
At the moment, there is no data regarding feasibility and efficacy of STC, but two pilot RCTs of STC are currently underway, one in Western Australia and one in Wisconsin, USA. The aim of the current study is to evaluate feasibility and efficacy of STC as a webinar in a pilot RCT in German.
- Being tested
- STC
- Keywords
- Stigma, Parents of children with mental illness, Disclosure, Secrecy, Group intervention
- Medical subject headings
- Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STCBehavioural
The peer-led and web-based group program contains four lessons plus one booster session:
- Lesson 1: Consider the pros and cons of disclosing: Participants reflect on their experience of self-stigma and weight their pros and cons of (non-)disclosing their child's mental illness.
- Lesson 2: Different ways to disclose: Participants learn about different ways to disclose and their respective pros and cons. Afterwards participants discuss possible responses they might experience and develop strategies to cope with.
- Lesson 3: Communication about disclosure between parents and their child: Participants discuss pros and cons of (non-)disclosure for their children and how to negotiate whether to disclose or not.
- Lesson 4: Telling your story: Participants learn how to tell their own story.
- In a booster session, participants discuss their experiences with disclosure or non-disclosure.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (STC) | Experimental | Study participants randomized to the experimental group receive the intervention (STC). STC is a peer-led and web-based group intervention containing four two-hour sessions within four weeks plus an additional booster session one month later.
Fidelity to manual is rated in each session by study staff. Receives: Behavioral: STC |
| No intervention | No intervention | Participants randomized to the control group do not receive the group program but get the accompanying workbook at the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (9)
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.
Measured: baseline, 4 weeks, 16 weeks
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.
Measured: baseline, 4 weeks, 8 weeks, 16 weeks
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.
Measured: baseline, 4 weeks, 8 weeks, 16 weeks
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.
Measured: baseline, 4 weeks, 8 weeks, 16 weeks
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.
Measured: baseline, 4 weeks, 8 weeks, 16 weeks
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.
Measured: baseline, 4 weeks, 8 weeks, 16 weeks
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.
Measured: baseline, 4 weeks, 8 weeks, 16 weeks
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.
Measured: baseline, 4 weeks, 8 weeks, 16 weeks
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.
Measured: baseline, 4 weeks, 8 weeks, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Oct 2019
- Primary completion1 Feb 2021
- Study completion1 May 2021
Why it stopped: The study was terminated due to a small number of study participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Stigma of Parents of Children With Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas Rüsch, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107714
- Sponsor's protocol ID
- 375/18
- Acronym
- STC
- Status last verified
- May 2021
- First submitted
- 25 Sep 2019
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29956016Morris 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.
PubMed 29436312Rusch 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.
PubMed 19237266Rusch 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.
PubMed 19269140Tröster 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.
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.
The KIDSCREEN Group Europe. The Kidscreen questionnaires: Quality of life questionnaires for children and adolescents: handbook. Lengerich: Pabst Science Publishers; 2006.
Kliem S, Mossle T, Rehbein F, Hellmann DF, Zenger M, Brahler 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.
PubMed 25499982Hacking 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.
PubMed 18484974Secker 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
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starting the Conversation (STC) - Web-based Group Intervention to Support Disclosure Decisions for Parents of Children With Mental Illness
- ClinicalTrials.gov ID
- NCT04107714
- Acronym / sponsor ID
- STC / 375/18
- Keywords
- Stigma, Parents of children with mental illness, Disclosure, Secrecy, Group intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to a small number of study participants.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of UlmUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Parents of children with mental illness often experience public and self-stigma, and keeping a child's mental illness secret is a common strategy to avoid stigma. Both secrecy and disclosure have pros and cons for parents and their children. Therefore, the decision whether, when, and to whom to disclose a child's mental illness is complex. Interventions can provide guidance for systematic consideration and a well informed decision.
The manualized peer-led group intervention "Honest, Open, Proud" (HOP) supports people with mental illness in their decision whether to disclose mental illness. Research showed positive effects of the intervention on stigma stress, disclosure-related distress and quality of life. Based on HOP, "Starting the Conversation" (STC) was developed to systematically guide parents through their decision whether and how to disclose a child's mental illness.
At the moment, there is no data regarding feasibility and efficacy of STC, but two pilot RCTs of STC are currently underway, one in Western Australia and one in Wisconsin, USA. The aim of the current study is to evaluate feasibility and efficacy of STC as a webinar in a pilot RCT in German.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (STC) | Experimental | Behavioral: STCStudy participants randomized to the experimental group receive the intervention (STC). STC is a peer-led and web-based group intervention containing four two-hour sessions within four weeks plus an additional booster session one month later. Fidelity to manual is rated in each session by study staff. |
| No intervention | No intervention | –Participants randomized to the control group do not receive the group program but get the accompanying workbook at the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Intellectual disability of child (IQ<70, self-report)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STCThe peer-led and web-based group program contains four lessons plus one booster session: * Lesson 1: Consider the pros and cons of disclosing: Participants reflect on their experience of self-stigma and weight their pros and cons of (non-)disclosing their child's mental illness. * Lesson 2: Different ways to disclose: Participants learn about different ways to disclose and their respective pros and cons. Afterwards participants discuss possible responses they might experience and develop strategies to cope with. * Lesson 3: Communication about disclosure between parents and their child: Participants discuss pros and cons of (non-)disclosure for their children and how to negotiate whether to disclose or not. * Lesson 4: Telling your story: Participants learn how to tell their own story. * In a booster session, participants discuss their experiences with disclosure or non-disclosure. | Behavioural | Intervention (STC) |
Primary outcome
Self-stigma of parents
Time frame: 8 weeks
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.
9 secondary outcomes
Self-stigma of parents
Time frame: baseline, 4 weeks, 16 weeks
Self-stigma of parents
Time frame: baseline, 4 weeks, 8 weeks, 16 weeks
Stigma stress related to child's mental illness
Time frame: baseline, 4 weeks, 8 weeks, 16 weeks
Parenting distress
Time frame: baseline, 4 weeks, 8 weeks, 16 weeks
Quality of life of parents
Time frame: baseline, 4 weeks, 8 weeks, 16 weeks
Parent-rated child quality of life
Time frame: baseline, 4 weeks, 8 weeks, 16 weeks
Self-esteem
Time frame: baseline, 4 weeks, 8 weeks, 16 weeks
Social support
Time frame: baseline, 4 weeks, 8 weeks, 16 weeks
Social inclusion
Time frame: baseline, 4 weeks, 8 weeks, 16 weeks
Results and safety
The study was stopped early (reason given: The study was terminated due to a small number of study participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Background: PubMed 29956016Eaton 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.
- Background: PubMed 29436312Morris 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.
- Background: PubMed 19237266Rusch 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.
- Background: PubMed 19269140Rusch 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.
- BackgroundTröster 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.
- BackgroundAngermeyer 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.
- BackgroundThe KIDSCREEN Group Europe. The Kidscreen questionnaires: Quality of life questionnaires for children and adolescents: handbook. Lengerich: Pabst Science Publishers; 2006.
- Background: PubMed 25499982Kliem S, Mossle T, Rehbein F, Hellmann DF, Zenger M, Brahler 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.
- Background: PubMed 18484974Hacking 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.
- BackgroundSecker 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing STC in people with Stigma of Parents of Children With Mental Illness, run by University of Ulm at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to a small number of study participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-stigma of parents (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04107714, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.