Mental IllnessNCT06572865
Identifying Parents in Child Welfare Services Who Need Mental Health Support: Depression and Anxiety Symptoms
An observational study of Mental Illness and Depression, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The main aim of this study is to examine the occurrence of mental health symptoms among parents referred to the Swedish child welfare services for child maltreatment and other family related risks. Additionally, to examine any variables associated with parents' levels of depression and anxiety. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Illness, Depression, Anxiety
- What is being tested?
- Screening for depression and anxiety
- How many people
- 155 participants
- Where
- 1 siteSweden
- Study dates
- 29 Nov 2024to 5 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Parents reported to the social services due to concerns of the child\'s well-being.
Who may be able to join
- A parental role in relation to a child 0-17 years old (the participant does not be a guardian or biological parent, can also be, for example, a partner to a parent).
- A child welfare report has been filed for the child or the parent has reached out to the CWS themselves.
Who cannot join
- Not able to read questionnaire in any available language and interpreter not available at the social services.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Parents in Child Welfare Services Who Need Mental Health Support: Depression and Anxiety Symptoms and Associated Factors
The main aim of this study is to examine the occurrence of mental health symptoms among parents referred to the Swedish child welfare services for child maltreatment and other family related risks. Additionally, to examine any variables associated with parents' levels of depression and anxiety.
Parents will respond to questionnaires administered by social workers. The level of depression and anxiety will be descriptively and statistically compared to clinical and normative samples. Additionally, statistical analyses will examine variables associated with parents' mental health symptoms.
Read the detailed description
BACKGROUND:
Parental mental illness is associated with various family-related risks, including child maltreatment and children developing own psychiatric conditions. Studies indicate that parental mental illness is more prevalent in families into contact with the child welfare system due to child maltreatment or other risk conditions. However, there is a lack of studies that routinely examine the well-being of parents reported for child maltreatment. Furthermore, there is limited knowledge of whether the severity of parental symptoms varies based on the reasons for the child welfare report.
PURPOSE AND RESEARCH QUESTIONS:
The main aim of this study is to assess the occurrence of mental health symptoms among parents referred to the child welfare services (CWS) and whether any factors are associated with the level of symptoms. The research questions are:
- Is the average level of depression and anxiety among parents reported to CWS different from that in normative and clinical populations?
- Are parent and family characteristics, the reason for the child welfare involvement, or previous involvement with CWS associated with parents' levels of depression and anxiety?
METHODS:
This is a cross-sectional study using data collected within a feasibility study of the Collaboration-Screening-Referral model (in Swedish: Samverkan-Screening-Hänvisning - SSH) - an approach to screen parents for symptoms of mental illness using structured questionnaires, establish intra-agency collaboration, and refer to mental health services. An evaluation of the effects, feasibility and experiences of the SSH-model is presented in a separate study: Screening to Identify Parents in Need of Mental Health Support: A Feasibility Study in Child Welfare Services. The present study presents data from the questionnaire administered to parents.
CWS agencies in Swedish municipalities will be recruited to take part in the research project. Social workers will receive training in employing screening for depression and anxiety. Then, they will administer a questionnaire measuring symptoms of depression and anxiety to parents they meet as a part of routine work. They will be encouraged to present the screening to every eligible parent they meet. When parents have responded to questionnaires, it is followed by a discussion about well-being and support needs. When relevant, the social worker provides information about what mental health support is available.
Parents' data will be anonymous. The multiple-choice questions will be restricted and phrased in a way that prevents identification. The survey will be made available in several languages.
SAMPLE SIZE CALCULATION AND ANALYSES:
Mean values from the instruments will be presented descriptively. Also, compared statistically (using t-test or ANOVA) to established cut-off values/clinical samples as well as data from parents in the general population. To take account of possible nesting effects resulting of parents from the same families responding, the alpha will conservatively be set to 0.025. At least 290 participants are needed for an 80% power (alpha = 0.025) to detect a small mean difference (d = 0.20). Additionally, multiple linear regression analyses will examine variables associated with parents' symptoms.
- Conditions
- Mental Illness, Depression, Anxiety
- Being tested
- Screening for depression and anxiety
- Keywords
- Mental Illness, Depression, Anxiety, Parenting
- Medical subject headings
- Mental Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for depression and anxietyOther
Parents respond to questionnaires assessing depression and anxiety.
| Study group | Role | What they receive |
|---|---|---|
| Parents reported to the child welfare services | Adults who are into contact with the Swedish CWS due to a child welfare report. The adults have a parental role in relation to a child 0-17 years old (referred to as 'parents'). Receives: Other: Screening for depression and anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Patient Health Questionnaire
The Patient Health Questionnaire (PHQ-9) will be used to assess depressive symptoms, including suicidal ideation, over the last two weeks (9 questions). Items are scored 0-3, resulting in a total score of 0-27. Higher scores indicate more symptoms of depression.
Measured: At inclusion, each participant will be assessed one time only.
The GAD-7
The 7-item GAD-7 will measure symptoms of anxiety. Items are scored 0-3, resulting in a total score of 0-21. Higher scores indicate more symptoms of anxiety.
Measured: At inclusion, each participant will be assessed one time only.
Secondary outcomes (3)
Parents' background
Parent will respond to a few questions about their background when responding to the screening questionnaire.
Measured: At inclusion, each participant will be assessed one time only.
Parents' contact with mental health services
In the screening questionnaire, parents will be asked whether they are currently or have previously been in contact with healthcare services for their mental health.
Measured: At inclusion, each participant will be assessed one time only.
Characteristics of the contact with child welfare services
In the parents' questionnaires, previous contact with child welfare services will be recorded, along with the reason for the current involvement with child welfare services.
Measured: At inclusion, each participant will be assessed one time only.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start29 Nov 2024
- Primary completion5 May 2026
- Study completion5 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Forster, Karolinska Institutet
- Investigators
- Martin Forster, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572865
- Sponsor's protocol ID
- Parent symptoms CWS
- Status last verified
- Oct 2026
- First submitted
- 23 Aug 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Parents in Child Welfare Services Who Need Mental Health Support: Depression and Anxiety Symptoms and Associated Factors
- ClinicalTrials.gov ID
- NCT06572865
- Acronym / sponsor ID
- Parent symptoms CWS
- Conditions
- Mental Illness, Depression, Anxiety
- Keywords
- Mental Illness, Depression, Anxiety, Parenting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 5 May 2026 (actual)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to examine the occurrence of mental health symptoms among parents referred to the Swedish child welfare services for child maltreatment and other family related risks. Additionally, to examine any variables associated with parents' levels of depression and anxiety.
Parents will respond to questionnaires administered by social workers. The level of depression and anxiety will be descriptively and statistically compared to clinical and normative samples. Additionally, statistical analyses will examine variables associated with parents' mental health symptoms.
Detailed description
BACKGROUND:
Parental mental illness is associated with various family-related risks, including child maltreatment and children developing own psychiatric conditions. Studies indicate that parental mental illness is more prevalent in families into contact with the child welfare system due to child maltreatment or other risk conditions. However, there is a lack of studies that routinely examine the well-being of parents reported for child maltreatment. Furthermore, there is limited knowledge of whether the severity of parental symptoms varies based on the reasons for the child welfare report.
PURPOSE AND RESEARCH QUESTIONS:
The main aim of this study is to assess the occurrence of mental health symptoms among parents referred to the child welfare services (CWS) and whether any factors are associated with the level of symptoms. The research questions are:
- Is the average level of depression and anxiety among parents reported to CWS different from that in normative and clinical populations?
- Are parent and family characteristics, the reason for the child welfare involvement, or previous involvement with CWS associated with parents' levels of depression and anxiety?
METHODS:
This is a cross-sectional study using data collected within a feasibility study of the Collaboration-Screening-Referral model (in Swedish: Samverkan-Screening-Hänvisning - SSH) - an approach to screen parents for symptoms of mental illness using structured questionnaires, establish intra-agency collaboration, and refer to mental health services. An evaluation of the effects, feasibility and experiences of the SSH-model is presented in a separate study: Screening to Identify Parents in Need of Mental Health Support: A Feasibility Study in Child Welfare Services. The present study presents data from the questionnaire administered to parents.
CWS agencies in Swedish municipalities will be recruited to take part in the research project. Social workers will receive training in employing screening for depression and anxiety. Then, they will administer a questionnaire measuring symptoms of depression and anxiety to parents they meet as a part of routine work. They will be encouraged to present the screening to every eligible parent they meet. When parents have responded to questionnaires, it is followed by a discussion about well-being and support needs. When relevant, the social worker provides information about what mental health support is available.
Parents' data will be anonymous. The multiple-choice questions will be restricted and phrased in a way that prevents identification. The survey will be made available in several languages.
SAMPLE SIZE CALCULATION AND ANALYSES:
Mean values from the instruments will be presented descriptively. Also, compared statistically (using t-test or ANOVA) to established cut-off values/clinical samples as well as data from parents in the general population. To take account of possible nesting effects resulting of parents from the same families responding, the alpha will conservatively be set to 0.025. At least 290 participants are needed for an 80% power (alpha = 0.025) to detect a small mean difference (d = 0.20). Additionally, multiple linear regression analyses will examine variables associated with parents' symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents reported to the child welfare services | – | Other: Screening for depression and anxietyAdults who are into contact with the Swedish CWS due to a child welfare report. The adults have a parental role in relation to a child 0-17 years old (referred to as 'parents'). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents reported to the social services due to concerns of the child\'s well-being.
Key inclusion criteria (2 listed)
- A parental role in relation to a child 0-17 years old (the participant does not be a guardian or biological parent, can also be, for example, a partner to a parent).
- A child welfare report has been filed for the child or the parent has reached out to the CWS themselves.
Key exclusion criteria (1 listed)
- Not able to read questionnaire in any available language and interpreter not available at the social services.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for depression and anxietyParents respond to questionnaires assessing depression and anxiety. | Other | Parents reported to the child welfare services |
Primary outcome
The Patient Health Questionnaire
Time frame: At inclusion, each participant will be assessed one time only.
The Patient Health Questionnaire (PHQ-9) will be used to assess depressive symptoms, including suicidal ideation, over the last two weeks (9 questions). Items are scored 0-3, resulting in a total score of 0-27. Higher scores indicate more symptoms of depression.
The GAD-7
Time frame: At inclusion, each participant will be assessed one time only.
The 7-item GAD-7 will measure symptoms of anxiety. Items are scored 0-3, resulting in a total score of 0-21. Higher scores indicate more symptoms of anxiety.
3 secondary outcomes
Parents' background
Time frame: At inclusion, each participant will be assessed one time only.
Parents' contact with mental health services
Time frame: At inclusion, each participant will be assessed one time only.
Characteristics of the contact with child welfare services
Time frame: At inclusion, each participant will be assessed one time only.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Forster principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Illness and Depression, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Patient Health Questionnaire (time frame: At inclusion, each participant will be assessed one time only.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.