Starting the Conversation (STC)

University of Ulm

Status and phase: Terminated; Phase 2

Conditions: Stigma of Parents of Children With Mental Illness

Treatments: Behavioral: STC

Study type: Interventional

Funder types: Other

Identifiers

NCT04107714

375/18

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Intervention (STC)

Experimental group

Description:

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.

Treatment:

Behavioral: STC

No intervention

No Intervention group

Description:

Participants randomized to the control group do not receive the group program but get the accompanying workbook at the end of the study.