AnxietyNCT05854602

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

A study testing Component A, Component B and Component C in people with Anxiety, run by University of Amsterdam at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 7 to 11 years
Conditions the study is for: Anxiety
What is being tested?: Component A, Component B and Component C
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 266 participants
Where: 1 siteNetherlands
Study dates: 1 Nov 2023to 13 Mar 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 7 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

University of Amsterdam
Amsterdam

Other trials in Netherlands

About this study

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.

Conditions: Anxiety
Being tested: Component A, Component B, Component C
Keywords: Anxiety, Children, Parents, Prevention, Intervention
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Component ABehavioural
Also called Family Accommodation
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.
Component BBehavioural
Also called Empathetic Reactions
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.
Component CBehavioural
Also called Cognitive Restructuring
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.

Study groups in NCT05854602
Study group	Role	What they receive
Condition 1: 000	No intervention	Families in this condition will not receive any of the intervention components during study period (T0-T2, T2-T4, T4-T6). Target n = 35.
Condition 2: 0A0	Experimental	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. Receives: Behavioral: Component A
Condition 3: 00A	Experimental	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. Receives: Behavioral: Component A
Condition 4: 0AB	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component B
Condition 5: 0AC	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component C
Condition 6: 0B0	Experimental	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. Receives: Behavioral: Component B
Condition 7: 00B	Experimental	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. Receives: Behavioral: Component B
Condition 8: 0BA	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component B
Condition 9: 0BC	Experimental	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. Receives: Behavioral: Component B; Behavioral: Component C
Condition 10: 0C0	Experimental	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. Receives: Behavioral: Component C
Condition 11: 00C	Experimental	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. Receives: Behavioral: Component C
Condition 12: 0CA	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component C
Condition 13: 0CB	Experimental	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. Receives: Behavioral: Component B; Behavioral: Component C
Condition 14: A00	Experimental	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. Receives: Behavioral: Component A
Condition 15: A0B	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component B
Condition 16: A0C	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component C
Condition 17: AB0	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component B
Condition 18: ABC	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component B; Behavioral: Component C
Condition 19: AC0	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component C
Condition 20: ACB	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component B; Behavioral: Component C
Condition 21: B00	Experimental	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. Receives: Behavioral: Component B
Condition 22: B0A	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component B
Condition 23: B0C	Experimental	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. Receives: Behavioral: Component B; Behavioral: Component C
Condition 24: BA0	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component B
Condition 25: BAC	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component B; Behavioral: Component C
Condition 26: BC0	Experimental	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. Receives: Behavioral: Component B; Behavioral: Component C
Condition 27: BCA	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component B; Behavioral: Component C
Condition 28: C00	Experimental	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. Receives: Behavioral: Component C
Condition 29: C0A	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component C
Condition 30: C0B	Experimental	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. Receives: Behavioral: Component B; Behavioral: Component C
Condition 31: CA0	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component C
Condition 32: CAB	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component B; Behavioral: Component C
Condition 33: CB0	Experimental	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. Receives: Behavioral: Component B; Behavioral: Component C
Condition 34: CBA	Experimental	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. Receives: Behavioral: Component A; Behavioral: Component B; Behavioral: Component C

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline (T0)
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.
Measured: Two weeks after baseline (T2)
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.
Measured: Four weeks after baseline (T4)
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.
Measured: Six weeks after baseline (T6)
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.
Measured: Twelve weeks after baseline (T12, follow-up)

Secondary outcomes (20)

Child Life impairment
Child Anxiety Life Interference Scale . Higher scores indicate more life interference.
Measured: Baseline (T0)
Child Life impairment
Child Anxiety Life Interference Scale. Higher scores indicate more life interference.
Measured: Two weeks after baseline (T2)
Child Life impairment
Child Anxiety Life Interference Scale. Higher scores indicate more life interference.
Measured: Four weeks after baseline (T4)
Child Life impairment
Child Anxiety Life Interference Scale. Higher scores indicate more life interference.
Measured: Six weeks after baseline (T6)
Child Life impairment
Child Anxiety Life Interference Scale. Higher scores indicate more life interference.
Measured: Twelve weeks after baseline (T12, follow-up)
Family Accommodation
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Measured: Baseline (T0)
Family Accommodation
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Measured: Two weeks after baseline (T2)
Family Accommodation
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Measured: Four weeks after baseline (T4)
Family Accommodation
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Measured: Six weeks after baseline (T6)
Family Accommodation
Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.
Measured: Twelve weeks after baseline (T12, follow-up)
Parental Empathetic Reactions to Child Anxiety
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Measured: Baseline (T0)
Parental Empathetic Reactions to Child Anxiety
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Measured: Two weeks after baseline (T2)
Parental Empathetic Reactions to Child Anxiety
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Measured: Four weeks after baseline (T4)
Parental Empathetic Reactions to Child Anxiety
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Measured: Six weeks after baseline (T6)
Parental Empathetic Reactions to Child Anxiety
Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.
Measured: Twelve weeks after baseline (T12, follow-up)
Parental Cognitions about Child Anxiety
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Measured: Baseline (T0)
Parental Cognitions about Child Anxiety
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Measured: Two weeks after baseline (T2)
Parental Cognitions about Child Anxiety
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Measured: Four weeks after baseline (T4)
Parental Cognitions about Child Anxiety
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Measured: Six weeks after baseline (T6)
Parental Cognitions about Child Anxiety
Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.
Measured: Twelve weeks after baseline (T12, follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202313 Mar 2026

First posted11 May 2023
Study start1 Nov 2023
Primary completion13 Mar 2026
Study completion13 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Model description: A Factorial Experiment with 34 conditions
Masking: Single blind
Who is masked: Participant
Enrolment: 266 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05854602
Sponsor's protocol ID: VI.Vidi.201.065 - Study 5
Status last verified: Apr 2026
First submitted: 19 Apr 2023
Last updated: 5 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Fully anonymized data will be publicly shared after publication of the project results.

Publications

Bodden DH, Bogels SM, Muris P. The diagnostic utility of the Screen for Child Anxiety Related Emotional Disorders-71 (SCARED-71). Behav Res Ther. 2009 May;47(5):418-25. doi: 10.1016/j.brat.2009.01.015. Epub 2009 Jan 30.
PubMed 19230863
Lyneham HJ, Sburlati ES, Abbott MJ, Rapee RM, Hudson JL, Tolin DF, Carlson SE. Psychometric properties of the Child Anxiety Life Interference Scale (CALIS). J Anxiety Disord. 2013 Oct;27(7):711-9. doi: 10.1016/j.janxdis.2013.09.008. Epub 2013 Sep 26.
PubMed 24135256
Lebowitz ER, Woolston J, Bar-Haim Y, Calvocoressi L, Dauser C, Warnick E, Scahill L, Chakir AR, Shechner T, Hermes H, Vitulano LA, King RA, Leckman JF. Family accommodation in pediatric anxiety disorders. Depress Anxiety. 2013 Jan;30(1):47-54. doi: 10.1002/da.21998. Epub 2012 Sep 10.
PubMed 22965863
Francis SE, Chorpita BF. Development and Evaluation of the Parental Beliefs about Anxiety Questionnaire. J Psychopathol Behav Assess. 2010;32(1):138-149. doi:10.1007/s10862-009-9133-5
Weisz JR, Vaughn-Coaxum RA, Evans SC, Thomassin K, Hersh J, Ng MY, Lau N, Lee EH, Raftery-Helmer JN, Mair P. Efficient Monitoring of Treatment Response during Youth Psychotherapy: The Behavior and Feelings Survey. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):737-751. doi: 10.1080/15374416.2018.1547973. Epub 2019 Jan 18.
PubMed 30657721
Lovibond SH, Lovibond PF. Manual for the Depression Anxiety Stress Scales. 2nd ed. Psychology Foundation of Australia; 1995.
de Beurs E, Van Dyck R, Marquenie LA, Lange A, Blonk RWB. De DASS: Een vragenlijst voor het meten van depressie, angst en stress. [The DASS: A questionnaire for the measurement of depression, anxiety, and stress.]. Gedragstherapie. 2001;34:35-53.
Dozois DJ, Westra HA. Development of the Anxiety Change Expectancy Scale (ACES) and validation in college, community, and clinical samples. Behav Res Ther. 2005 Dec;43(12):1655-72. doi: 10.1016/j.brat.2004.12.001.
PubMed 15922290
van der Sterren-Kusters WJC, van der Heijden PT, Egger JIM. Psychometric Properties of the Dutch Anxiety Change Expectancy Scale (ACES-NL). Int J Psychol Psychol Ther. 2017;17:189-198.
Aron A, Aron EN, Smollan D. Inclusion of Other in the Self Scale and the structure of interpersonal closeness. J Pers Soc Psychol. 1992;63:596-612. doi:10.1037/0022-3514.63.4.596
Brummelman E, Thomaes S, Slagt M, Overbeek G, de Castro BO, Bushman BJ. My Child Redeems My Broken Dreams: On Parents Transferring Their Unfulfilled Ambitions onto Their Child. PLoS One. 2013 Jun 19;8(6):e65360. doi: 10.1371/journal.pone.0065360. Print 2013.
PubMed 23840325
Bishop G, Spence SH, McDonald C. Can parents and teachers provide a reliable and valid report of behavioral inhibition? Child Dev. 2003 Nov-Dec;74(6):1899-917. doi: 10.1046/j.1467-8624.2003.00645.x.
PubMed 14669903
Duncan BL, Miller SD, Sparks JA, et al. The Session Rating Scale: Preliminary Psychometric Properties of a "Working" Alliance Measure. J Brief Ther. 2003;3(1):3-12.
Kazdin AE. Acceptability of child treatment techniques: The influence of treatment efficacy and adverse side effects. Behav Ther. 1981;12(4):493-506. doi:10.1016/S0005-7894(81)80087-1
Kelley ML, Heffer RW, Gresham FM, Elliott SN. Development of a modified treatment evaluation inventory. J Psychopathol Behav Assess. 1989;11(3):235-247. doi:10.1007/BF00960495

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Relative Effects of Three Parent-Intervention Components to Reduce Children's Anxiety
ClinicalTrials.gov ID: NCT05854602
Acronym / sponsor ID: VI.Vidi.201.065 - Study 5
Conditions: Anxiety
Keywords: Anxiety, Children, Parents, Prevention, Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 266 participants (actual)
Lead sponsor: University of AmsterdamUniversity, hospital or other
Collaborators: Netherlands Organisation for Scientific Research
Study start: 1 Nov 2023 (actual)
Primary completion: 13 Mar 2026 (actual)
Study completion: 13 Mar 2026 (actual)
First posted: 11 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 34
Model description: A Factorial Experiment with 34 conditions

Arm	Type	Receives
Condition 1: 000	No intervention	–Families in this condition will not receive any of the intervention components during study period (T0-T2, T2-T4, T4-T6). Target n = 35.
Condition 2: 0A0	Experimental	Behavioral: Component AThis 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.
Condition 3: 00A	Experimental	Behavioral: Component AThis 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.
Condition 4: 0AB	Experimental	Behavioral: Component A, Behavioral: Component BThis 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.
Condition 5: 0AC	Experimental	Behavioral: Component A, Behavioral: Component CThis 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.
Condition 6: 0B0	Experimental	Behavioral: Component BThis 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.
Condition 7: 00B	Experimental	Behavioral: Component BThis 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.
Condition 8: 0BA	Experimental	Behavioral: Component A, Behavioral: Component BThis 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.
Condition 9: 0BC	Experimental	Behavioral: Component B, Behavioral: Component CThis 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.
Condition 10: 0C0	Experimental	Behavioral: Component CThis 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.
Condition 11: 00C	Experimental	Behavioral: Component CThis 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.
Condition 12: 0CA	Experimental	Behavioral: Component A, Behavioral: Component CThis 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.
Condition 13: 0CB	Experimental	Behavioral: Component B, Behavioral: Component CThis 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.
Condition 14: A00	Experimental	Behavioral: Component AThis 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.
Condition 15: A0B	Experimental	Behavioral: Component A, Behavioral: Component BThis 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.
Condition 16: A0C	Experimental	Behavioral: Component A, Behavioral: Component CThis 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.
Condition 17: AB0	Experimental	Behavioral: Component A, Behavioral: Component BThis 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.
Condition 18: ABC	Experimental	Behavioral: Component A, Behavioral: Component B, Behavioral: Component CThis 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.
Condition 19: AC0	Experimental	Behavioral: Component A, Behavioral: Component CThis 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.
Condition 20: ACB	Experimental	Behavioral: Component A, Behavioral: Component B, Behavioral: Component CThis 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.
Condition 21: B00	Experimental	Behavioral: Component BThis 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.
Condition 22: B0A	Experimental	Behavioral: Component A, Behavioral: Component BThis 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.
Condition 23: B0C	Experimental	Behavioral: Component B, Behavioral: Component CThis 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.
Condition 24: BA0	Experimental	Behavioral: Component A, Behavioral: Component BThis 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.
Condition 25: BAC	Experimental	Behavioral: Component A, Behavioral: Component B, Behavioral: Component CThis 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.
Condition 26: BC0	Experimental	Behavioral: Component B, Behavioral: Component CThis 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.
Condition 27: BCA	Experimental	Behavioral: Component A, Behavioral: Component B, Behavioral: Component CThis 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.
Condition 28: C00	Experimental	Behavioral: Component CThis 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.
Condition 29: C0A	Experimental	Behavioral: Component A, Behavioral: Component CThis 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.
Condition 30: C0B	Experimental	Behavioral: Component B, Behavioral: Component CThis 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.
Condition 31: CA0	Experimental	Behavioral: Component A, Behavioral: Component CThis 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.
Condition 32: CAB	Experimental	Behavioral: Component A, Behavioral: Component B, Behavioral: Component CThis 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.
Condition 33: CB0	Experimental	Behavioral: Component B, Behavioral: Component CThis 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.
Condition 34: CBA	Experimental	Behavioral: Component A, Behavioral: Component B, Behavioral: Component CThis 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.

Who may qualify

Ages: 7 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Component AAlso: Family AccommodationAll 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.	Behavioural	Condition 12: 0CA, Condition 14: A00, Condition 15: A0B, Condition 16: A0C, Condition 17: AB0, Condition 18: ABC, Condition 19: AC0, Condition 20: ACB, Condition 22: B0A, Condition 24: BA0, Condition 25: BAC, Condition 27: BCA, Condition 29: C0A, Condition 2: 0A0, Condition 31: CA0, Condition 32: CAB, Condition 34: CBA, Condition 3: 00A, Condition 4: 0AB, Condition 5: 0AC, Condition 8: 0BA
Component BAlso: Empathetic ReactionsAll 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.	Behavioural	Condition 13: 0CB, Condition 15: A0B, Condition 17: AB0, Condition 18: ABC, 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 30: C0B, Condition 32: CAB, Condition 33: CB0, Condition 34: CBA, Condition 4: 0AB, Condition 6: 0B0, Condition 7: 00B, Condition 8: 0BA, Condition 9: 0BC
Component CAlso: Cognitive RestructuringAll 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.	Behavioural	Condition 10: 0C0, Condition 11: 00C, Condition 12: 0CA, Condition 13: 0CB, Condition 16: A0C, Condition 18: ABC, Condition 19: AC0, Condition 20: ACB, Condition 23: B0C, 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, Condition 5: 0AC, Condition 9: 0BC

Primary outcome

Child Anxiety
Time frame: Baseline (T0)
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
Time frame: Two weeks after baseline (T2)
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
Time frame: Four weeks after baseline (T4)
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
Time frame: Six weeks after baseline (T6)
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
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.

20 secondary outcomes

Child Life impairment
Time frame: Baseline (T0)
Child Life impairment
Time frame: Two weeks after baseline (T2)
Child Life impairment
Time frame: Four weeks after baseline (T4)
Child Life impairment
Time frame: Six weeks after baseline (T6)
Child Life impairment
Time frame: Twelve weeks after baseline (T12, follow-up)
Family Accommodation
Time frame: Baseline (T0)
Family Accommodation
Time frame: Two weeks after baseline (T2)
Family Accommodation
Time frame: Four weeks after baseline (T4)
Family Accommodation
Time frame: Six weeks after baseline (T6)
Family Accommodation
Time frame: Twelve weeks after baseline (T12, follow-up)
Parental Empathetic Reactions to Child Anxiety
Time frame: Baseline (T0)
Parental Empathetic Reactions to Child Anxiety
Time frame: Two weeks after baseline (T2)
Parental Empathetic Reactions to Child Anxiety
Time frame: Four weeks after baseline (T4)
Parental Empathetic Reactions to Child Anxiety
Time frame: Six weeks after baseline (T6)
Parental Empathetic Reactions to Child Anxiety
Time frame: Twelve weeks after baseline (T12, follow-up)
Parental Cognitions about Child Anxiety
Time frame: Baseline (T0)
Parental Cognitions about Child Anxiety
Time frame: Two weeks after baseline (T2)
Parental Cognitions about Child Anxiety
Time frame: Four weeks after baseline (T4)
Parental Cognitions about Child Anxiety
Time frame: Six weeks after baseline (T6)
Parental Cognitions about Child Anxiety
Time frame: Twelve weeks after baseline (T12, follow-up)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
Background: PubMed 19230863Bodden DH, Bogels SM, Muris P. The diagnostic utility of the Screen for Child Anxiety Related Emotional Disorders-71 (SCARED-71). Behav Res Ther. 2009 May;47(5):418-25. doi: 10.1016/j.brat.2009.01.015. Epub 2009 Jan 30.
Background: PubMed 24135256Lyneham HJ, Sburlati ES, Abbott MJ, Rapee RM, Hudson JL, Tolin DF, Carlson SE. Psychometric properties of the Child Anxiety Life Interference Scale (CALIS). J Anxiety Disord. 2013 Oct;27(7):711-9. doi: 10.1016/j.janxdis.2013.09.008. Epub 2013 Sep 26.
Background: PubMed 22965863Lebowitz ER, Woolston J, Bar-Haim Y, Calvocoressi L, Dauser C, Warnick E, Scahill L, Chakir AR, Shechner T, Hermes H, Vitulano LA, King RA, Leckman JF. Family accommodation in pediatric anxiety disorders. Depress Anxiety. 2013 Jan;30(1):47-54. doi: 10.1002/da.21998. Epub 2012 Sep 10.
BackgroundFrancis SE, Chorpita BF. Development and Evaluation of the Parental Beliefs about Anxiety Questionnaire. J Psychopathol Behav Assess. 2010;32(1):138-149. doi:10.1007/s10862-009-9133-5
Background: PubMed 30657721Weisz JR, Vaughn-Coaxum RA, Evans SC, Thomassin K, Hersh J, Ng MY, Lau N, Lee EH, Raftery-Helmer JN, Mair P. Efficient Monitoring of Treatment Response during Youth Psychotherapy: The Behavior and Feelings Survey. J Clin Child Adolesc Psychol. 2020 Nov-Dec;49(6):737-751. doi: 10.1080/15374416.2018.1547973. Epub 2019 Jan 18.
BackgroundLovibond SH, Lovibond PF. Manual for the Depression Anxiety Stress Scales. 2nd ed. Psychology Foundation of Australia; 1995.
Backgroundde Beurs E, Van Dyck R, Marquenie LA, Lange A, Blonk RWB. De DASS: Een vragenlijst voor het meten van depressie, angst en stress. [The DASS: A questionnaire for the measurement of depression, anxiety, and stress.]. Gedragstherapie. 2001;34:35-53.
Background: PubMed 15922290Dozois DJ, Westra HA. Development of the Anxiety Change Expectancy Scale (ACES) and validation in college, community, and clinical samples. Behav Res Ther. 2005 Dec;43(12):1655-72. doi: 10.1016/j.brat.2004.12.001.
Backgroundvan der Sterren-Kusters WJC, van der Heijden PT, Egger JIM. Psychometric Properties of the Dutch Anxiety Change Expectancy Scale (ACES-NL). Int J Psychol Psychol Ther. 2017;17:189-198.
BackgroundAron A, Aron EN, Smollan D. Inclusion of Other in the Self Scale and the structure of interpersonal closeness. J Pers Soc Psychol. 1992;63:596-612. doi:10.1037/0022-3514.63.4.596
Background: PubMed 23840325Brummelman E, Thomaes S, Slagt M, Overbeek G, de Castro BO, Bushman BJ. My Child Redeems My Broken Dreams: On Parents Transferring Their Unfulfilled Ambitions onto Their Child. PLoS One. 2013 Jun 19;8(6):e65360. doi: 10.1371/journal.pone.0065360. Print 2013.
Background: PubMed 14669903Bishop G, Spence SH, McDonald C. Can parents and teachers provide a reliable and valid report of behavioral inhibition? Child Dev. 2003 Nov-Dec;74(6):1899-917. doi: 10.1046/j.1467-8624.2003.00645.x.
Individual participant dataSharing planned: Yes. Fully anonymized data will be publicly shared after publication of the project results.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karen Rienks, MSc principal investigator

University of Amsterdam

Patty Leijten, Dr study director

University of Amsterdam

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Component A, Component B and Component C in people with Anxiety, run by University of Amsterdam at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Anxiety (time frame: Baseline (T0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05854602, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.