Clinical trial NCT05854602: The Relative Effects of Three Parent-Intervention Components to Reduce Children's Anxiety
Official title: The Relative Effects of Three Parent-Intervention Components to Reduce Children's Anxiety
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Keywords: Anxiety
Children
Parents
Prevention
Intervention
Lead sponsor: University of Amsterdam
Sponsor class: OTHER
Collaborators: name: Netherlands Organisation for Scientific Research
First posted: 2023-05-11
Enrollment: 266
Sex: ALL
Minimum age (years): 7
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A Factorial Experiment with 34 conditions
Primary purpose: PREVENTION

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.


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:

None

Primary outcomes:
measure: Child Anxiety
timeFrame: Baseline (T0)
measure: Child Anxiety
timeFrame: Two weeks after baseline (T2)
measure: Child Anxiety
timeFrame: Four weeks after baseline (T4)
measure: Child Anxiety
timeFrame: Six weeks after baseline (T6)
measure: Child Anxiety
timeFrame: Twelve weeks after baseline (T12, follow-up)
Secondary outcomes:
measure: Child Life impairment
timeFrame: Baseline (T0)
measure: Child Life impairment
timeFrame: Two weeks after baseline (T2)
measure: Child Life impairment
timeFrame: Four weeks after baseline (T4)
measure: Child Life impairment
timeFrame: Six weeks after baseline (T6)
measure: Child Life impairment
timeFrame: Twelve weeks after baseline (T12, follow-up)
measure: Family Accommodation
timeFrame: Baseline (T0)
measure: Family Accommodation
timeFrame: Two weeks after baseline (T2)
measure: Family Accommodation
timeFrame: Four weeks after baseline (T4)
measure: Family Accommodation
timeFrame: Six weeks after baseline (T6)
measure: Family Accommodation
timeFrame: Twelve weeks after baseline (T12, follow-up)
measure: Parental Empathetic Reactions to Child Anxiety
timeFrame: Baseline (T0)
measure: Parental Empathetic Reactions to Child Anxiety
timeFrame: Two weeks after baseline (T2)
measure: Parental Empathetic Reactions to Child Anxiety
timeFrame: Four weeks after baseline (T4)
measure: Parental Empathetic Reactions to Child Anxiety
timeFrame: Six weeks after baseline (T6)
measure: Parental Empathetic Reactions to Child Anxiety
timeFrame: Twelve weeks after baseline (T12, follow-up)
measure: Parental Cognitions about Child Anxiety
timeFrame: Baseline (T0)
measure: Parental Cognitions about Child Anxiety
timeFrame: Two weeks after baseline (T2)
measure: Parental Cognitions about Child Anxiety
timeFrame: Four weeks after baseline (T4)
measure: Parental Cognitions about Child Anxiety
timeFrame: Six weeks after baseline (T6)
measure: Parental Cognitions about Child Anxiety
timeFrame: Twelve weeks after baseline (T12, follow-up)
Other outcomes:
measure: Child general mental health
timeFrame: Baseline (T0)
measure: Child general mental health
timeFrame: Six weeks after baseline (T6)
measure: Child general mental health
timeFrame: Twelve weeks after baseline (T12, follow-up)
measure: Parental Anxiety
timeFrame: Baseline (T0)
measure: Parental Anxiety
timeFrame: Two weeks after baseline (T2)
measure: Parental Anxiety
timeFrame: Four weeks after baseline (T4)
measure: Parental Anxiety
timeFrame: Six weeks after baseline (T6)
measure: Parental Anxiety
timeFrame: Twelve weeks after baseline (T12, follow-up)
measure: Parental self-efficacy
timeFrame: Baseline (T0)
measure: Parental self-efficacy
timeFrame: Two weeks after baseline (T2)
measure: Parental self-efficacy
timeFrame: Four weeks after baseline (T4)
measure: Parental self-efficacy
timeFrame: Six weeks after baseline (T6)
measure: Parental self-efficacy
timeFrame: Twelve weeks after baseline (T12, follow-up)
measure: Parental anxiety change expectancy
timeFrame: Baseline (T0)
measure: Parental anxiety change expectancy
timeFrame: Two weeks after baseline (T2)
measure: Parental anxiety change expectancy
timeFrame: Four weeks after baseline (T4)
measure: Parental anxiety change expectancy
timeFrame: Six weeks after baseline (T6)
measure: Parental anxiety change expectancy
timeFrame: Twelve weeks after baseline (T12, follow-up)
measure: Parent-child interactions
timeFrame: Baseline (T0)
measure: Parent-child interactions
timeFrame: Six weeks after baseline (T6)
measure: Parent-child interactions
timeFrame: Twelve weeks after baseline (T12, follow-up)
measure: Clinician rated child anxiety
timeFrame: Baseline (T0)
measure: Clinician rated child anxiety
timeFrame: Six weeks after baseline (T6)
measure: Clinician rated child anxiety
timeFrame: Twelve weeks after baseline (T12, follow-up)
Locations:
Study officials:
affiliation: University of Amsterdam
name: Karen Rienks, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Amsterdam
name: Patty Leijten, Dr
role: STUDY_DIRECTOR
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