Starting the Conversation

Phase 2

Terminated

• Conditions: Stigma of Parents of Children With Mental Illness

• Registration Number: NCT04107714
• Lead Sponsor: University of Ulm

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.

Study Timeline

• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Study Start: 2019-10-01
• Primary Completion: 2021-02-01
• Status Verified: 2021-05
• Study Completion: 2021-05-01
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-stigma of parents	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.

Secondary Outcome Measures

Name	Time	Method
Parent-rated child quality of life	baseline, 4 weeks, 8 weeks, 16 weeks	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.
Self-stigma of parents	baseline, 4 weeks, 8 weeks, 16 weeks	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.
Social inclusion	baseline, 4 weeks, 8 weeks, 16 weeks	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.
Stigma stress related to child's mental illness	baseline, 4 weeks, 8 weeks, 16 weeks	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.
Parenting distress	baseline, 4 weeks, 8 weeks, 16 weeks	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.
Quality of life of parents	baseline, 4 weeks, 8 weeks, 16 weeks	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.
Self-esteem	baseline, 4 weeks, 8 weeks, 16 weeks	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.
Social support	baseline, 4 weeks, 8 weeks, 16 weeks	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.

Trial Locations

Locations (1)

Department of Child and Adolescent Psychiatry, University of Ulm; 🇩🇪 Ulm, Germany