Clinical trial NCT04107714: Starting the Conversation
Official title: Starting the Conversation (STC) - Web-based Group Intervention to Support Disclosure Decisions for Parents of Children With Mental Illness
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Stigma of Parents of Children With Mental Illness
Keywords: Stigma
Parents of children with mental illness
Disclosure
Secrecy
Group intervention
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Self-stigma of parents
timeFrame: 8 weeks
Secondary outcomes:
measure: Self-stigma of parents
timeFrame: baseline, 4 weeks, 16 weeks
measure: Self-stigma of parents
timeFrame: baseline, 4 weeks, 8 weeks, 16 weeks
measure: Stigma stress related to child's mental illness
timeFrame: baseline, 4 weeks, 8 weeks, 16 weeks
measure: Parenting distress
timeFrame: baseline, 4 weeks, 8 weeks, 16 weeks
measure: Quality of life of parents
timeFrame: baseline, 4 weeks, 8 weeks, 16 weeks
measure: Parent-rated child quality of life
timeFrame: baseline, 4 weeks, 8 weeks, 16 weeks
measure: Self-esteem
timeFrame: baseline, 4 weeks, 8 weeks, 16 weeks
measure: Social support
timeFrame: baseline, 4 weeks, 8 weeks, 16 weeks
measure: Social inclusion
timeFrame: baseline, 4 weeks, 8 weeks, 16 weeks
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Department of Child and Adolescent Psychiatry, University of Ulm
Study officials:
References:
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citation: 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.
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