NCT06572865

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

November 29, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2026

Completed
Last Updated

August 25, 2026

Status Verified

August 1, 2026

Enrollment Period

1.4 years

First QC Date

August 23, 2024

Last Update Submit

August 23, 2026

Conditions

Keywords

Mental IllnessDepressionAnxietyParenting

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    At inclusion, each participant will be assessed one time only.

Secondary Outcomes (3)

  • Parents' background

    At inclusion, each participant will be assessed one time only.

  • Parents' contact with mental health services

    At inclusion, each participant will be assessed one time only.

  • Characteristics of the contact with child welfare services

    At inclusion, each participant will be assessed one time only.

Study Arms (1)

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').

Other: Screening for depression and anxiety

Interventions

Parents respond to questionnaires assessing depression and anxiety.

Parents reported to the child welfare services

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parents reported to the social services due to concerns of the child\'s well-being.

You may qualify if:

  • 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.

You may not qualify if:

  • Not able to read questionnaire in any available language and interpreter not available at the social services.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Fagersta kommun

Fagersta, Sweden

Location

Gislaveds kommun

Gislaved, Sweden

Location

Söderhamns kommun

Söderhamn, Sweden

Location

Täby kommun

Täby, Sweden

Location

Tidaholms kommun

Tidaholm, Sweden

Location

Uppsala kommun

Uppsala, Sweden

Location

MeSH Terms

Conditions

Mental DisordersDepressionAnxiety Disorders

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Martin Forster

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 23, 2024

First Posted

August 27, 2024

Study Start

November 29, 2024

Primary Completion

May 5, 2026

Study Completion

May 5, 2026

Last Updated

August 25, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations