Starting the Conversation

NCT ID: NCT04107714

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2021-05-01

Brief 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).

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.

Conditions

Stigma of Parents of Children With Mental Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention (STC)

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.

Group Type: EXPERIMENTAL

STC

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

STC

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Ulm

OTHER

Sponsor Role: lead

Responsible Party

Nicolas Rüsch

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Child and Adolescent Psychiatry, University of Ulm

Ulm, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 29956016 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29436312 (View on PubMed)

Rusch 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.

Reference Type: BACKGROUND

PMID: 19237266 (View on PubMed)

Rusch 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.

Reference Type: BACKGROUND

PMID: 19269140 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

The KIDSCREEN Group Europe. The Kidscreen questionnaires: Quality of life questionnaires for children and adolescents: handbook. Lengerich: Pabst Science Publishers; 2006.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 25499982 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18484974 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

375/18

Identifier Type: -

Identifier Source: org_study_id