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

NCT05854602 | Completed

• 1 other identifier: VI.Vidi.201.065 - Study 5
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Keywords

Anxiety; Children; Parents; Prevention; Intervention

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  Twelve weeks after baseline (T12, follow-up)

Secondary Outcomes (20)

• Child Life impairment

  Baseline (T0)

• Child Life impairment

  Two weeks after baseline (T2)

• Child Life impairment

  Four weeks after baseline (T4)

• Child Life impairment

  Six weeks after baseline (T6)

• Child Life impairment

  Twelve weeks after baseline (T12, follow-up)

Other Outcomes (24)

• Child general mental health

  Baseline (T0)

• Child general mental health

  Six weeks after baseline (T6)

• Child general mental health

  Twelve weeks after baseline (T12, follow-up)

Study Arms (34)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Behavioral: Component A; Behavioral: Component B; Behavioral: Component C

Interventions

Component A BEHAVIORAL

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.

Also known as: Family Accommodation

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 B BEHAVIORAL

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.

Also known as: Empathetic Reactions

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 C BEHAVIORAL

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.

Also known as: Cognitive Restructuring

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

Eligibility Criteria

• Age: 7 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Amsterdam: lead
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (1)

University of Amsterdam

Amsterdam, Netherlands

Location

Related Publications (18)

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  BACKGROUND

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  BACKGROUND

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• 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.

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• 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.

  PMID: 14669903 BACKGROUND

• 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.

  BACKGROUND

• 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

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  BACKGROUND

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  BACKGROUND

• Comer JS, Conroy K, Cornacchio D, Furr JM, Norman SB, Stein MB. Psychometric evaluation of a caregiver-report adaptation of the Overall Anxiety Severity and Impairment Scale (OASIS) for use with youth populations. J Affect Disord. 2022 Mar 1;300:341-348. doi: 10.1016/j.jad.2021.12.113. Epub 2021 Dec 31.

  PMID: 34979182 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Cognitive Restructuring

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Karen Rienks, MSc

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

• Patty Leijten, Dr

  University of Amsterdam

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: A Factorial Experiment with 34 conditions

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 11, 2023
• Study Start: November 1, 2023
• Primary Completion: March 13, 2026
• Study Completion: March 13, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: After publication of project results
• 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.

Locations

NL (1)