Starting the Conversation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Starting the Conversation (STC) - Web-based Group Intervention to Support Disclosure Decisions for Parents of Children With Mental Illness

Conditions
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Stigma of Parents of Children With Mental Illness

Intervention / Treatment
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* Behavioral: STC


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (STC)<br>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. | Behavioral: STC<br>* 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.<br>|
| No Intervention: No intervention<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stigma, Parents of children with mental illness, Disclosure, Secrecy, Group intervention