Starting the Conversation (STC)

May 4, 2021 updated by: Nicolas Rüsch, University of Ulm

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Ulm, Germany, 89073
        • Department of Child and Adolescent Psychiatry, University of Ulm

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

February 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

September 25, 2019

First Submitted That Met QC Criteria

September 25, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 4, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 375/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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