Table 1 Summary of study design

Primary registry and trial identifying number

ChiCTR

ChiCTR2300073904

Date of registration in primary registry

2023–07-25

Secondary identifying numbers

Protocol number CAFF20230725

Source(s) of monetary or material support

China Medical Board

Primary sponsor

China Medical Board

Secondary sponsor(s)

Care for Families Program (Beijing, China)

Contact for public queries

Lili Guan, MD, MPH, guanlili@bjmu.edu.cn

Contact for scientific queries

Lili Guan, MD, MPH, guanlili@bjmu.edu.cn

Public title

"Let’s Talk About Children" Family Focused Intervention for Children of Parents with Severe Mental Disorders: Protocol for a Randomized Controlled Trial

Scientific title

"Let’s Talk About Children" Family Focused Intervention for Children of Parents with Severe Mental Disorders: Protocol for a Randomized Controlled Trial

Countries of recruitment

China

Health condition(s) or problem(s) studied

Schizophrenia, Bipolar Disorder

Intervention(s)

Intervention group: Let’s Talk about Children;

Control group: Treatment as usual, which typically includes medication, case management, outpatient consultations and rehabilitation services;

Key inclusion and exclusion criteria

Inclusion criteria are:

1. At least one child that is at least 8 years old and not yet 18 years old in the family;

2. One biological parent has met ICD-10 diagnostic criteria for schizophrenia or bipolar disorder for at least one year;

3. In the past year, the patient has lived with the child(ren) for at least 6 months;

4. Patient and their child(ren) can understand the study and provide written informed consent

Exclusion criteria are:

1. Previous or current participation in family therapy;

2. Patient has been hospitalized or has visited the emergency room in the past month due to their mental illness, or presence of self-harm, suicidal or aggressive behaviour in the past month;

3. Patient or their child(ren) has severe cognitive impairment, learning disabilities, communication difficulties or behavioural problems;

4. Anticipated difficulty in completing the intervention or follow-ups for the next 7 months for any reason (i.e., moving away);

5. Single parent households at the time of enrolment (parent is divorced or widow(er)ed and is not remarried);

6. Both parents suffer from severe mental illnesses, including schizophrenia, bipolar disorder, schizoaffective disorder, delusional disorder, or other psychotic disorders

Discontinuation criteria:

1. During the intervention or follow-up period, patient is hospitalized or visits the emergency room due to their mental illness, or exhibits self-harm, suicidal or aggressive behaviour, or is diagnosed with other severe medical conditions;

2. During the intervention or follow-up period, the spouse or child(ren) is diagnosed with a severe mental disorder (including schizophrenia, bipolar disorder, schizoaffective disorder, delusional disorder, or other psychotic disorders), or other severe medical conditions

Study type

Randomized Clinical Trial

Date of first enrolment

September, 2023

Target sample size

400

Recruitment status

Ongoing

Primary outcome(s)

Strengths and Difficulties Questionnaire;

Parent-Adolescent Communication Scale;

Key secondary outcomes

Child mental health; Child self-esteem; Quality of life; Parenting; Mental health knowledge