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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05854602
• Other study ID #: VI.Vidi.201.065 - Study 5
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: University of Amsterdam
• Contact: Karen Rienks, MSc
• Email: k.rienks[@]uva.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 266
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Behavioral:
• Component A
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 B
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 C
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Amsterdam	Netherlands Organisation for Scientific Research

References & Publications (18)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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

Gaumer Erickson AS, Soukup JH, Noonan PM, McGurn L. Empathy Formative Questionnaire. College & Career Competency Framework. 2015. https://www.cccframework.org/

Hamilton VE, Matthews JM, Crawford SB. Me as a Parent Questionnaire [Database record]. APA PsycTests. 2015. doi:10.1037/t45911-000

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

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. — View Citation

Lovibond SH, Lovibond PF. Manual for the Depression Anxiety Stress Scales. 2nd ed. Psychology Foundation of Australia; 1995.

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. — View Citation

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.

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child general mental health	Behavior and Feeling Survey (anxiety scale omitted). Higher scores indicate worse mental health.	Baseline (T0)
Other	Child general mental health	Behavior and Feeling Survey (anxiety scale omitted). Higher scores indicate worse mental health.	Six weeks after baseline (T6)
Other	Child general mental health	Behavior and Feeling Survey (anxiety scale omitted). Higher scores indicate worse mental health.	Twelve weeks after baseline (T12, follow-up)
Other	Parental Anxiety	Anxiety subscale DASS-21. Higher scores indicate more parental anxiety.	Baseline (T0)
Other	Parental Anxiety	Anxiety subscale DASS-21. Higher scores indicate more parental anxiety.	Two weeks after baseline (T2)
Other	Parental Anxiety	Anxiety subscale DASS-21. Higher scores indicate more parental anxiety.	Four weeks after baseline (T4)
Other	Parental Anxiety	Anxiety subscale DASS-21. Higher scores indicate more parental anxiety.	Six weeks after baseline (T6)
Other	Parental Anxiety	Anxiety subscale DASS-21	Twelve weeks after baseline (T12, follow-up)
Other	Parental self-efficacy	Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy.	Baseline (T0)
Other	Parental self-efficacy	Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy.	Two weeks after baseline (T2)
Other	Parental self-efficacy	Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy.	Four weeks after baseline (T4)
Other	Parental self-efficacy	Self-efficacy subscale Me as a Parent . Higher scores indicate more self-efficacy.	Six weeks after baseline (T6)
Other	Parental self-efficacy	Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy.	Twelve weeks after baseline (T12, follow-up)
Other	Parental anxiety change expectancy	Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.	Baseline (T0)
Other	Parental anxiety change expectancy	Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.	Two weeks after baseline (T2)
Other	Parental anxiety change expectancy	Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.	Four weeks after baseline (T4)
Other	Parental anxiety change expectancy	Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.	Six weeks after baseline (T6)
Other	Parental anxiety change expectancy	Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.	Twelve weeks after baseline (T12, follow-up)
Other	Parent-child interactions	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.	Baseline (T0)
Other	Parent-child interactions	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.	Six weeks after baseline (T6)
Other	Parent-child interactions	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.	Twelve weeks after baseline (T12, follow-up)
Other	Clinician rated child anxiety	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.	Baseline (T0)
Other	Clinician rated child anxiety	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.	Six weeks after baseline (T6)
Other	Clinician rated child anxiety	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.	Twelve weeks after baseline (T12, follow-up)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	Child Life impairment	Child Anxiety Life Interference Scale . Higher scores indicate more life interference.	Baseline (T0)
Secondary	Child Life impairment	Child Anxiety Life Interference Scale. Higher scores indicate more life interference.	Two weeks after baseline (T2)
Secondary	Child Life impairment	Child Anxiety Life Interference Scale. Higher scores indicate more life interference.	Four weeks after baseline (T4)
Secondary	Child Life impairment	Child Anxiety Life Interference Scale. Higher scores indicate more life interference.	Six weeks after baseline (T6)
Secondary	Child Life impairment	Child Anxiety Life Interference Scale. Higher scores indicate more life interference.	Twelve weeks after baseline (T12, follow-up)
Secondary	Family Accommodation	Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.	Baseline (T0)
Secondary	Family Accommodation	Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.	Two weeks after baseline (T2)
Secondary	Family Accommodation	Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.	Four weeks after baseline (T4)
Secondary	Family Accommodation	Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.	Six weeks after baseline (T6)
Secondary	Family Accommodation	Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.	Twelve weeks after baseline (T12, follow-up)
Secondary	Parental Empathetic Reactions to Child Anxiety	Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.	Baseline (T0)
Secondary	Parental Empathetic Reactions to Child Anxiety	Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.	Two weeks after baseline (T2)
Secondary	Parental Empathetic Reactions to Child Anxiety	Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.	Four weeks after baseline (T4)
Secondary	Parental Empathetic Reactions to Child Anxiety	Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.	Six weeks after baseline (T6)
Secondary	Parental Empathetic Reactions to Child Anxiety	Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.	Twelve weeks after baseline (T12, follow-up)
Secondary	Parental Cognitions about Child Anxiety	Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.	Baseline (T0)
Secondary	Parental Cognitions about Child Anxiety	Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.	Two weeks after baseline (T2)
Secondary	Parental Cognitions about Child Anxiety	Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.	Four weeks after baseline (T4)
Secondary	Parental Cognitions about Child Anxiety	Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.	Six weeks after baseline (T6)
Secondary	Parental Cognitions about Child Anxiety	Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.	Twelve weeks after baseline (T12, follow-up)