The CHIP-Family intervention for young children with congenital heart disease and their family: a randomized controlled trial

Completed

• Conditions: congenital heart defects; congenital heart disease; 10010394

• Registration Number: NL-OMON46273
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 92

Inclusion Criteria

Children who underwent at least one invasive cardiac procedure (catheter intervention, surgery) for CHD in the Erasmus MC and who are approximately 4 to 7 years old at time of the first, i.e. baseline, assessment. All types of congenital heart defects (and a comparable number of kindergarten vs. primary school children) will be included.

Exclusion Criteria

a) Child*s mental intellectual impairment (IQ < 70) (due to a specified syndrome) as ascertained by previous standardized assessment or diagnosed by a clinician;
b) parental inability to read/write Dutch;
c) prematurely born children (<37 weeks pregnancy) with only a patent ductus arteriosus and no other CHD.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>(Please also see METC protocol par. 8, which also includes references)<br /><br><br /><br>Main study parameters/endpoints assessed at baseline assessment (T1) and at 6<br /><br>months follow-up (T2):<br /><br>- For children: Child behavioral/emotional problems (CBCL)<br /><br>- For parents: Parental mental health (SCL-90-R)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>(Please also see METC protocol par. 8, which also includes references)<br /><br><br /><br>Secondary study parameters/endpoints, assessed at T1 and T2 (unless otherwise<br /><br>specified):<br /><br>- For children: school days sick/absent (T2), school/cognitive functioning,<br /><br>executive functioning, pleasure in sports, quality of life<br /><br>- For parents: parental worry/stress, quality of life<br /><br>- For siblings: quality of life<br /><br>- For family: family functioning<br /><br>- CHD-related: disease-specific knowledge, illness perception, medical<br /><br>consumption<br /><br>- Social validity (T2; satisfaction regarding CHIP-Family)<br /><br><br /><br>Predictor variables, assessed at T1 and T2:<br /><br>Demographic variables (T1), medical variables (cardiac diagnosis, New Your<br /><br>Heart Association classification), life events</p><br>