Back to resultsThe Relative Effects of Three Parent-Intervention Components to Reduce Children's Anxiety
Primary Purpose
Anxiety
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Component A
Component B
Component C
Sponsored by
About this trial
This is an interventional prevention trial for Anxiety focused on measuring Anxiety, Children, Parents, Prevention, Intervention
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Arm 11
Arm 12
Arm 13
Arm 14
Arm 15
Arm 16
Arm 17
Arm 18
Arm 19
Arm 20
Arm 21
Arm 22
Arm 23
Arm 24
Arm 25
Arm 26
Arm 27
Arm 28
Arm 29
Arm 30
Arm 31
Arm 32
Arm 33
Arm 34
Arm Type
No Intervention
Experimental
Experimental
Experimental
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Experimental
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Experimental
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Experimental
Experimental
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Arm Label
Condition 1: 000
Condition 2: 0A0
Condition 3: 00A
Condition 4: 0AB
Condition 5: 0AC
Condition 6: 0B0
Condition 7: 00B
Condition 8: 0BA
Condition 9: 0BC
Condition 10: 0C0
Condition 11: 00C
Condition 12: 0CA
Condition 13: 0CB
Condition 14: A00
Condition 15: A0B
Condition 16: A0C
Condition 17: AB0
Condition 18: ABC
Condition 19: AC0
Condition 20: ACB
Condition 21: B00
Condition 22: B0A
Condition 23: B0C
Condition 24: BA0
Condition 25: BAC
Condition 26: BC0
Condition 27: BCA
Condition 28: C00
Condition 29: C0A
Condition 30: C0B
Condition 31: CA0
Condition 32: CAB
Condition 33: CB0
Condition 34: CBA
Arm Description
Families in this condition will not receive any of the intervention components during study period (T0-T2, T2-T4, T4-T6). Target n = 35.
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
Outcomes
Primary Outcome Measures
Child Anxiety
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.
Child Anxiety
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.
Child Anxiety
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.
Child Anxiety
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.
Child Anxiety
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 Outcome Measures
Child Life impairment
Child Anxiety Life Interference Scale . Higher scores indicate more life interference.
Child Life impairment
Child Anxiety Life Interference Scale. Higher scores indicate more life interference.
Child Life impairment
Child Anxiety Life Interference Scale. Higher scores indicate more life interference.
Child Life impairment
Child Anxiety Life Interference Scale. Higher scores indicate more life interference.
Child Life impairment
Child Anxiety Life Interference Scale. Higher scores indicate more life interference.
Family Accommodation
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Family Accommodation
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Family Accommodation
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Family Accommodation
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Family Accommodation
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Parental Empathetic Reactions to Child Anxiety
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Parental Empathetic Reactions to Child Anxiety
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Parental Empathetic Reactions to Child Anxiety
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Parental Empathetic Reactions to Child Anxiety
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Parental Empathetic Reactions to Child Anxiety
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Parental Cognitions about Child Anxiety
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Parental Cognitions about Child Anxiety
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Parental Cognitions about Child Anxiety
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Parental Cognitions about Child Anxiety
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Parental Cognitions about Child Anxiety
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Full Information
NCT ID
NCT05854602
First Posted
April 19, 2023
Last Updated
October 12, 2023
Sponsor
University of Amsterdam
Collaborators
Netherlands Organisation for Scientific Research
1. Study Identification
Unique Protocol Identification Number
NCT05854602
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Amsterdam
Collaborators
Netherlands Organisation for Scientific Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
Anxiety, Children, Parents, Prevention, Intervention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
A Factorial Experiment with 34 conditions
Masking
Participant
Masking Description
Participants and researchers will be blinded to condition at enrolment and baseline assessment.
Randomization takes place after baseline assessment (T0), by drawing a number (1-34, corresponding to condition 1-34) from a sealed envelope, by a researcher who has no contact with any of the study participants.
Care providers cannot be blinded to participants' condition. At T2/4/6/12, Participants will be blinded to the conditions that exist in the study, but are aware of whether they received one or more intervention components.
Independent researchers and clinicians blinded to participants' condition and timepoint (T0/6/12) will code video recordings of the parent-child interaction task and parental stories about children's anxiety.
Allocation
Randomized
Enrollment
266 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Condition 1: 000
Arm Type
No Intervention
Arm Description
Families in this condition will not receive any of the intervention components during study period (T0-T2, T2-T4, T4-T6). Target n = 35.
Arm Title
Condition 2: 0A0
Arm Type
Experimental
Arm Description
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 3: 00A
Arm Type
Experimental
Arm Description
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 4: 0AB
Arm Type
Experimental
Arm Description
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 5: 0AC
Arm Type
Experimental
Arm Description
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 6: 0B0
Arm Type
Experimental
Arm Description
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 7: 00B
Arm Type
Experimental
Arm Description
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 8: 0BA
Arm Type
Experimental
Arm Description
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 9: 0BC
Arm Type
Experimental
Arm Description
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 10: 0C0
Arm Type
Experimental
Arm Description
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 11: 00C
Arm Type
Experimental
Arm Description
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 12: 0CA
Arm Type
Experimental
Arm Description
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 13: 0CB
Arm Type
Experimental
Arm Description
This intervention condition received no intervention from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 14: A00
Arm Type
Experimental
Arm Description
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 15: A0B
Arm Type
Experimental
Arm Description
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 16: A0C
Arm Type
Experimental
Arm Description
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 17: AB0
Arm Type
Experimental
Arm Description
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 18: ABC
Arm Type
Experimental
Arm Description
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 19: AC0
Arm Type
Experimental
Arm Description
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 20: ACB
Arm Type
Experimental
Arm Description
This intervention condition received Component A from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 21: B00
Arm Type
Experimental
Arm Description
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 22: B0A
Arm Type
Experimental
Arm Description
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 23: B0C
Arm Type
Experimental
Arm Description
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 24: BA0
Arm Type
Experimental
Arm Description
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 25: BAC
Arm Type
Experimental
Arm Description
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and Component C from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 26: BC0
Arm Type
Experimental
Arm Description
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 27: BCA
Arm Type
Experimental
Arm Description
This intervention condition received Component B from baseline (T0) to the second measurement point two weeks later (T2), Component C from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 28: C00
Arm Type
Experimental
Arm Description
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 29: C0A
Arm Type
Experimental
Arm Description
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 30: C0B
Arm Type
Experimental
Arm Description
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), no intervention from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 31: CA0
Arm Type
Experimental
Arm Description
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 32: CAB
Arm Type
Experimental
Arm Description
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), Component A from T2 to two weeks later (T4), and Component B from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 33: CB0
Arm Type
Experimental
Arm Description
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and no intervention from T4 to two weeks later (T6). Target n = 7.
Arm Title
Condition 34: CBA
Arm Type
Experimental
Arm Description
This intervention condition received Component C from baseline (T0) to the second measurement point two weeks later (T2), Component B from T2 to two weeks later (T4), and Component A from T4 to two weeks later (T6). Target n = 7.
Intervention Type
Behavioral
Intervention Name(s)
Component A
Other Intervention Name(s)
Family Accommodation
Intervention Description
All components consist of one online therapist-led session, and 14 daily assignments. In the online session, parents watch an animation clip explaining the technique, and parents perform an exercise guided by the therapist. In the daily assignments, parents reflect on situations in which their child was anxious during the day in which they (could have) applied the technique. If the child was not anxious that day, parents are asked to think about a future or past situation and fill in similar questions.
Component A focusses on making parents aware of the process of avoidance in children with anxiety, and helps them to identify situations in which they accommodate to the anxiety of their children. Subsequently, a first step that parents can take to reduce accommodation is discussed.
Intervention Type
Behavioral
Intervention Name(s)
Component B
Other Intervention Name(s)
Empathetic Reactions
Intervention Description
All components consist of one online therapist-led session, and 14 daily assignments. In the online session, parents watch an animation clip explaining the technique, and parents perform an exercise guided by the therapist. In the daily assignments, parents reflect on situations in which their child was anxious during the day in which they (could have) applied the technique. If the child was not anxious that day, parents are asked to think about a future or past situation and fill in similar questions.
Component B tries to increase parents empathetic reactions to their anxious child. This is done by teaching parents to label the emotion of their children, empathize with the emotion, and communicate confidence in the abilities of their child to face the situation.
Intervention Type
Behavioral
Intervention Name(s)
Component C
Other Intervention Name(s)
Cognitive Restructuring
Intervention Description
All components consist of one online therapist-led session, and 14 daily assignments. In the online session, parents watch an animation clip explaining the technique, and parents perform an exercise guided by the therapist. In the daily assignments, parents reflect on situations in which their child was anxious during the day in which they (could have) applied the technique. If the child was not anxious that day, parents are asked to think about a future or past situation and fill in similar questions.
Component C consists of cognitive restructuring of parental maladaptive cognitions concerning their child's anxiety. Parents are taught to recognize their own cognitions about the anxiety of their child, challenge this thought and come up with an alternative, helpful thought.
Primary Outcome Measure Information:
Title
Child Anxiety
Description
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.
Time Frame
Baseline (T0)
Title
Child Anxiety
Description
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.
Time Frame
Two weeks after baseline (T2)
Title
Child Anxiety
Description
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.
Time Frame
Four weeks after baseline (T4)
Title
Child Anxiety
Description
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.
Time Frame
Six weeks after baseline (T6)
Title
Child Anxiety
Description
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.
Time Frame
Twelve weeks after baseline (T12, follow-up)
Secondary Outcome Measure Information:
Title
Child Life impairment
Description
Child Anxiety Life Interference Scale . Higher scores indicate more life interference.
Time Frame
Baseline (T0)
Title
Child Life impairment
Description
Child Anxiety Life Interference Scale. Higher scores indicate more life interference.
Time Frame
Two weeks after baseline (T2)
Title
Child Life impairment
Description
Child Anxiety Life Interference Scale. Higher scores indicate more life interference.
Time Frame
Four weeks after baseline (T4)
Title
Child Life impairment
Description
Child Anxiety Life Interference Scale. Higher scores indicate more life interference.
Time Frame
Six weeks after baseline (T6)
Title
Child Life impairment
Description
Child Anxiety Life Interference Scale. Higher scores indicate more life interference.
Time Frame
Twelve weeks after baseline (T12, follow-up)
Title
Family Accommodation
Description
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Time Frame
Baseline (T0)
Title
Family Accommodation
Description
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Time Frame
Two weeks after baseline (T2)
Title
Family Accommodation
Description
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Time Frame
Four weeks after baseline (T4)
Title
Family Accommodation
Description
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Time Frame
Six weeks after baseline (T6)
Title
Family Accommodation
Description
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Time Frame
Twelve weeks after baseline (T12, follow-up)
Title
Parental Empathetic Reactions to Child Anxiety
Description
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Time Frame
Baseline (T0)
Title
Parental Empathetic Reactions to Child Anxiety
Description
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Time Frame
Two weeks after baseline (T2)
Title
Parental Empathetic Reactions to Child Anxiety
Description
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Time Frame
Four weeks after baseline (T4)
Title
Parental Empathetic Reactions to Child Anxiety
Description
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Time Frame
Six weeks after baseline (T6)
Title
Parental Empathetic Reactions to Child Anxiety
Description
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Time Frame
Twelve weeks after baseline (T12, follow-up)
Title
Parental Cognitions about Child Anxiety
Description
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Time Frame
Baseline (T0)
Title
Parental Cognitions about Child Anxiety
Description
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Time Frame
Two weeks after baseline (T2)
Title
Parental Cognitions about Child Anxiety
Description
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Time Frame
Four weeks after baseline (T4)
Title
Parental Cognitions about Child Anxiety
Description
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Time Frame
Six weeks after baseline (T6)
Title
Parental Cognitions about Child Anxiety
Description
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Time Frame
Twelve weeks after baseline (T12, follow-up)
Other Pre-specified Outcome Measures:
Title
Child general mental health
Description
Behavior and Feeling Survey (anxiety scale omitted). Higher scores indicate worse mental health.
Time Frame
Baseline (T0)
Title
Child general mental health
Description
Behavior and Feeling Survey (anxiety scale omitted). Higher scores indicate worse mental health.
Time Frame
Six weeks after baseline (T6)
Title
Child general mental health
Description
Behavior and Feeling Survey (anxiety scale omitted). Higher scores indicate worse mental health.
Time Frame
Twelve weeks after baseline (T12, follow-up)
Title
Parental Anxiety
Description
Anxiety subscale DASS-21. Higher scores indicate more parental anxiety.
Time Frame
Baseline (T0)
Title
Parental Anxiety
Description
Anxiety subscale DASS-21. Higher scores indicate more parental anxiety.
Time Frame
Two weeks after baseline (T2)
Title
Parental Anxiety
Description
Anxiety subscale DASS-21. Higher scores indicate more parental anxiety.
Time Frame
Four weeks after baseline (T4)
Title
Parental Anxiety
Description
Anxiety subscale DASS-21. Higher scores indicate more parental anxiety.
Time Frame
Six weeks after baseline (T6)
Title
Parental Anxiety
Description
Anxiety subscale DASS-21
Time Frame
Twelve weeks after baseline (T12, follow-up)
Title
Parental self-efficacy
Description
Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy.
Time Frame
Baseline (T0)
Title
Parental self-efficacy
Description
Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy.
Time Frame
Two weeks after baseline (T2)
Title
Parental self-efficacy
Description
Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy.
Time Frame
Four weeks after baseline (T4)
Title
Parental self-efficacy
Description
Self-efficacy subscale Me as a Parent . Higher scores indicate more self-efficacy.
Time Frame
Six weeks after baseline (T6)
Title
Parental self-efficacy
Description
Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy.
Time Frame
Twelve weeks after baseline (T12, follow-up)
Title
Parental anxiety change expectancy
Description
Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.
Time Frame
Baseline (T0)
Title
Parental anxiety change expectancy
Description
Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.
Time Frame
Two weeks after baseline (T2)
Title
Parental anxiety change expectancy
Description
Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.
Time Frame
Four weeks after baseline (T4)
Title
Parental anxiety change expectancy
Description
Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.
Time Frame
Six weeks after baseline (T6)
Title
Parental anxiety change expectancy
Description
Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.
Time Frame
Twelve weeks after baseline (T12, follow-up)
Title
Parent-child interactions
Description
Parent-child discussion task with increasing levels of difficulty. The task will be recorded, and coded by independent coders who are blind for the condition of the participants and timepoint of the recording. The observations will be coded for behavior relevant to those behaviors targeted in the intervention components.
Time Frame
Baseline (T0)
Title
Parent-child interactions
Description
Parent-child discussion task with increasing levels of difficulty. The task will be recorded, and coded by independent coders who are blind for the condition of the participants and timepoint of the recording. The observations will be coded for behavior relevant to those behaviors targeted in the intervention components.
Time Frame
Six weeks after baseline (T6)
Title
Parent-child interactions
Description
Parent-child discussion task with increasing levels of difficulty. The task will be recorded, and coded by independent coders who are blind for the condition of the participants and timepoint of the recording. The observations will be coded for behavior relevant to those behaviors targeted in the intervention components.
Time Frame
Twelve weeks after baseline (T12, follow-up)
Title
Clinician rated child anxiety
Description
Secondary clinician rated measure of child anxiety, additionally to the parent report. A verbal interview with the parents will be performed, using the questions of the Overall Anxiety Severity and Impairment Scale for youth (OASIS-Y). The questions will be presented as open-ended questions (i.e., without the original OASIS-Y multiple choice options), and parents are asked to answer freely. This will be recorded, and afterwards the answers will be coded by independent clinicians who will rate the parents' answers using the original OASIS-Y answer categories. Higher scores indicate a worse outcome.
Time Frame
Baseline (T0)
Title
Clinician rated child anxiety
Description
Secondary clinician rated measure of child anxiety, additionally to the parent report. A verbal interview with the parents will be performed, using the questions of the Overall Anxiety Severity and Impairment Scale for youth (OASIS-Y). The questions will be presented as open-ended questions (i.e., without the original OASIS-Y multiple choice options), and parents are asked to answer freely. This will be recorded, and afterwards the answers will be coded by independent clinicians who will rate the parents' answers using the original OASIS-Y answer categories. Higher scores indicate a worse outcome.
Time Frame
Six weeks after baseline (T6)
Title
Clinician rated child anxiety
Description
Secondary clinician rated measure of child anxiety, additionally to the parent report. A verbal interview with the parents will be performed, using the questions of the Overall Anxiety Severity and Impairment Scale for youth (OASIS-Y). The questions will be presented as open-ended questions (i.e., without the original OASIS-Y multiple choice options), and parents are asked to answer freely. This will be recorded, and afterwards the answers will be coded by independent clinicians who will rate the parents' answers using the original OASIS-Y answer categories. Higher scores indicate a worse outcome.
Time Frame
Twelve weeks after baseline (T12, follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Rienks, MSc
Email
k.rienks@uva.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Patty Leijten, Dr
Email
p.h.o.leijten@uva.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Rienks, MSc
Organizational Affiliation
University of Amsterdam
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patty Leijten, Dr
Organizational Affiliation
University of Amsterdam
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Fully anonymized data will be publicly shared after publication of the project results.
IPD Sharing Time Frame
After publication of project results
IPD Sharing Access Criteria
Via UvA Figshare data can be stored and shared on request. Requests are considered by the study officials. Together they decide whether anonymised data can be shared with a third party.
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The Relative Effects of Three Parent-Intervention Components to Reduce Children's Anxiety
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