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Clinical Trials/NCT05854602
NCT05854602
Not yet recruiting
Not Applicable

The Relative Effects of Three Parent-Intervention Components to Reduce Children's Anxiety

University of Amsterdam0 sites266 target enrollmentNovember 2023
ConditionsAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anxiety
Sponsor
University of Amsterdam
Enrollment
266
Primary Endpoint
Child Anxiety
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

This trial will test the relative effects of three parent-intervention components to reduce emerging anxiety problems in children aged 7-11. The components are: reducing family accommodation (Component A), increasing empathetic reactions to children's anxiety (Component B), and cognitive restructuring to reduce maladaptive parental thoughts about children's anxiety (Component C). The components were selected based on their distinct theoretical backgrounds and their frequent use in existing intervention programs. The investigators will use a full factorial experiment with all possible combinations and orders of components. The study period will be twelve weeks with five points of data-collection: T0 (baseline), T2 (two weeks post baseline, immediately after the first component), T4 (four weeks post baseline, immediately after the second component), T6 (six weeks post baseline, immediately after the third component) and T12 (12 weeks post baseline, follow-up).

Our overarching research questions are:

  • How effective are Component A, B, and C in reducing children's anxiety symptoms? The effects of the components will be compared with each other, and with a control condition. This will be investigated both from T0 to T2 (i.e., effects of the individual components) and from T0 to T6 and T0 to T12 (i.e., effects of the components controlled for the presence of other components).
  • How effective are the components in reducing children's life impairment? The effects of the components will be compared with each other, and with a control condition.
  • Are effects of the components on children's anxiety mediated by changes in the parental risk factors that they target? (i.e., family accommodation for Component A, empathetic reactions for Component B, and parental maladaptive beliefs about child anxiety for Component C)
  • Is there a dose-response effect such that children whose parents received more intervention components benefit more in terms of reduced anxiety symptoms in children?
  • What parent, child, and intervention characteristics moderate the effects of the components on children's anxiety? In addition to basic sociodemographic information, the investigators will collect data on several putative moderators: the extent to which parents see their child as part of themselves (Inclusion of Child in the Self Scale), children's behavioural inhibition (Behavioural Inhibition Questionnaire), therapist alliance (Session Rating Scale), acceptability of the intervention (TEI-SF), other caregiver's use of the intervention components.
Registry
clinicaltrials.gov
Start Date
November 2023
End Date
December 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karen Rienks

PhD Candidate

University of Amsterdam

Eligibility Criteria

Inclusion Criteria

  • Child aged 7;0 - 11;11 years old
  • Score of ≥ 4 on the screening questionnaire "Overall Anxiety Severity and Impairment Scale for Youth" (OASIS-Y; Comer et al., 2022) filled in by parents.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Child Anxiety

Time Frame: Twelve weeks after baseline (T12, follow-up)

Screen for Child Anxiety Related Emotional Disorders-NL Parent-version (71 item version but we omitted OCD and PTSS scale and used the remaining 58 items). Higher scores indicate higher anxiety.

Secondary Outcomes

  • Child Life impairment(Twelve weeks after baseline (T12, follow-up))
  • Parental Empathetic Reactions to Child Anxiety(Twelve weeks after baseline (T12, follow-up))
  • Parental Cognitions about Child Anxiety(Twelve weeks after baseline (T12, follow-up))
  • Family Accommodation(Twelve weeks after baseline (T12, follow-up))

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