Kunnen kinderen (niet) goed beslissen over meedoen aan medicatieonderzoek?

Development and use of a standardised instrument for assessing children’s competence to consent in drug trials: Are legally established age limits valid?

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27426

Enrollment

160

Registered

2013-03-25

Start date

2012-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

children's competence to consent, informed consent in minors, children's consent in drug trials. wilsbekwaamheid bij kinderen, informed consent bij minderjarigen, informed consent bij kinderen in medicatieonderzoek.

Interventions

1. Videotaping of the usual informed consent procedure

2. Modified MacCAT-CR semistructured interview

3. Wechsler Nonverbal IQ subtests.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 6-18 years; 2. In informed consent procedure of medical research.

Exclusion criteria

Exclusion criteria: Not speaking dutch.

Design outcomes

Primary

Measure	Time frame
1. MacCAT-CR scores and binary judgment of children's competence to consent; 2. Reference standard of children's competence to consent; 3. Validity and reliability of MacCAT-CR.	—

Secondary

Measure	Time frame
Correlation of children's competence to consent to age, IQ, parental judgment of children's competence, ethnicity, trial- and illnessexperience.	—

Contacts

Public ContactI.M. Hein

Meibergdreef 5

i.hein@debascule.com+31 (0)20 5663383

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)