Psychological distress, family-related factors and self-management in children with type 1 diabetes: a mixed-methods study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038756

Enrollment

100

Registered

2026-02-02

Start date

2026-02-02

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10

Interventions

Group 1: In this prospective, non-interventional study, standardized questionnaires are administered once at the time of study participation to children with type 1 diabetes. Children complete the St

Eligibility

Sex/Gender

All

Age

8 Years to 18 Years

Inclusion criteria

Inclusion criteria: Diagnosed type 1 diabetes mellitus Age 8–18 years Written informed consent from parents/legal guardians Age-appropriate assent from the child

Exclusion criteria

Exclusion criteria: Severe psychiatric disorders Insufficient language proficiency without access to professionally translated study materials Lack of informed consent

Design outcomes

Primary

Measure	Time frame
Psychological distress in children (SDQ) The level of psychological distress in children with type 1 diabetes. Time point of assessment The primary outcome will be assessed once at the time of study participation (cross-sectional assessment within a prospective observational study). Method of data collection Data will be collected using a combination of standardized questionnaires and qualitative interviews.	—

Measure

Time frame

Psychological distress in children (SDQ) The level of psychological distress in children with type 1 diabetes. Time point of assessment The primary outcome will be assessed once at the time of study participation (cross-sectional assessment within a prospective observational study). Method of data collection Data will be collected using a combination of standardized questionnaires and qualitative interviews.

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Secondary

Measure	Time frame
Secondary Outcome 1 – Self-management Endpoint / Outcome measure Level of diabetes-related self-management in children with type 1 diabetes. Time point of assessment Assessed once at the time of study participation. Method of data collection / Instrument Assessment using a standardized and validated questionnaire, the Self-Care Inventory-Revised (SCI-R), completed by the children. Data handling Data will be collected in a pseudonymized manner using a study-specific identification code. Secondary Outcome 2 – Family-related factors Endpoint / Outcome measure Family-related factors, particularly parental coping strategies in dealing with the child’s diabetes. Time point of assessment Assessed once at the time of study participation. Method of data collection / Instrument Assessment using the Brief COPE (parent version). In addition, semi-structured qualitative interviews with parents will be conducted to explore family-related factors in greater depth. Data handling Data will be collected in a pseudonymized manner. Secondary Outcome 3 – Parent-reported psychological distress Endpoint / Outcome measure Parent-reported psychological distress of the children. Time point of assessment Assessed once at the time of study participation. Method of data collection / Instrument Assessment using the Strengths and Difficulties Questionnaire (SDQ, parent version). Data handling Data will be collected in a pseudonymized manner.	—

Measure

Time frame

Secondary Outcome 1 – Self-management Endpoint / Outcome measure Level of diabetes-related self-management in children with type 1 diabetes. Time point of assessment Assessed once at the time of study participation. Method of data collection / Instrument Assessment using a standardized and validated questionnaire, the Self-Care Inventory-Revised (SCI-R), completed by the children. Data handling Data will be collected in a pseudonymized manner using a study-specific identification code. Secondary Outcome 2 – Family-related factors Endpoint / Outcome measure Family-related factors, particularly parental coping strategies in dealing with the child’s diabetes. Time point of assessment Assessed once at the time of study participation. Method of data collection / Instrument Assessment using the Brief COPE (parent version). In addition, semi-structured qualitative interviews with parents will be conducted to explore family-related factors in greater depth. Data handling Data will be collected in a pseudonymized manner. Secondary Outcome 3 – Parent-reported psychological distress Endpoint / Outcome measure Parent-reported psychological distress of the children. Time point of assessment Assessed once at the time of study participation. Method of data collection / Instrument Assessment using the Strengths and Difficulties Questionnaire (SDQ, parent version). Data handling Data will be collected in a pseudonymized manner.

—

Countries

Germany

Contacts

Public ContactMehdi Khodabakhshi

Uniklinik Bonn

mehdi.khodabakhshi@ukbonn.de+491794408988

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026