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Completed

NCT Number: NCT05854602

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Mental Disorders

Age range

7 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Amsterdam

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Family Accommodation

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.

Other names: Empathetic Reactions

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.

Other names: Cognitive Restructuring

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. Child Life impairment

    Time frame: Baseline (T0)

    Child Anxiety Life Interference Scale . Higher scores indicate more life interference.

  2. Child Life impairment

    Time frame: Two weeks after baseline (T2)

    Child Anxiety Life Interference Scale. Higher scores indicate more life interference.

  3. Child Life impairment

    Time frame: Four weeks after baseline (T4)

    Child Anxiety Life Interference Scale. Higher scores indicate more life interference.

  4. Child Life impairment

    Time frame: Six weeks after baseline (T6)

    Child Anxiety Life Interference Scale. Higher scores indicate more life interference.

  5. Child Life impairment

    Time frame: Twelve weeks after baseline (T12, follow-up)

    Child Anxiety Life Interference Scale. Higher scores indicate more life interference.

  6. Family Accommodation

    Time frame: Baseline (T0)

    Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.

  7. Family Accommodation

    Time frame: Two weeks after baseline (T2)

    Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.

  8. Family Accommodation

    Time frame: Four weeks after baseline (T4)

    Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.

  9. Family Accommodation

    Time frame: Six weeks after baseline (T6)

    Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.

  10. Family Accommodation

    Time frame: Twelve weeks after baseline (T12, follow-up)

    Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation.

  11. Parental Empathetic Reactions to Child Anxiety

    Time frame: Baseline (T0)

    Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.

  12. Parental Empathetic Reactions to Child Anxiety

    Time frame: Two weeks after baseline (T2)

    Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.

  13. Parental Empathetic Reactions to Child Anxiety

    Time frame: Four weeks after baseline (T4)

    Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.

  14. Parental Empathetic Reactions to Child Anxiety

    Time frame: Six weeks after baseline (T6)

    Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.

  15. Parental Empathetic Reactions to Child Anxiety

    Time frame: Twelve weeks after baseline (T12, follow-up)

    Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy.

  16. Parental Cognitions about Child Anxiety

    Time frame: Baseline (T0)

    Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.

  17. Parental Cognitions about Child Anxiety

    Time frame: Two weeks after baseline (T2)

    Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.

  18. Parental Cognitions about Child Anxiety

    Time frame: Four weeks after baseline (T4)

    Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.

  19. Parental Cognitions about Child Anxiety

    Time frame: Six weeks after baseline (T6)

    Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.

  20. Parental Cognitions about Child Anxiety

    Time frame: Twelve weeks after baseline (T12, follow-up)

    Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions.

Other outcomes

  1. Child general mental health

    Time frame: Baseline (T0)

    Behavior and Feeling Survey (anxiety scale omitted). Higher scores indicate worse mental health.

  2. Child general mental health

    Time frame: Six weeks after baseline (T6)

    Behavior and Feeling Survey (anxiety scale omitted). Higher scores indicate worse mental health.

  3. Child general mental health

    Time frame: Twelve weeks after baseline (T12, follow-up)

    Behavior and Feeling Survey (anxiety scale omitted). Higher scores indicate worse mental health.

  4. Parental Anxiety

    Time frame: Baseline (T0)

    Anxiety subscale DASS-21. Higher scores indicate more parental anxiety.

  5. Parental Anxiety

    Time frame: Two weeks after baseline (T2)

    Anxiety subscale DASS-21. Higher scores indicate more parental anxiety.

  6. Parental Anxiety

    Time frame: Four weeks after baseline (T4)

    Anxiety subscale DASS-21. Higher scores indicate more parental anxiety.

  7. Parental Anxiety

    Time frame: Six weeks after baseline (T6)

    Anxiety subscale DASS-21. Higher scores indicate more parental anxiety.

  8. Parental Anxiety

    Time frame: Twelve weeks after baseline (T12, follow-up)

    Anxiety subscale DASS-21

  9. Parental self-efficacy

    Time frame: Baseline (T0)

    Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy.

  10. Parental self-efficacy

    Time frame: Two weeks after baseline (T2)

    Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy.

  11. Parental self-efficacy

    Time frame: Four weeks after baseline (T4)

    Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy.

  12. Parental self-efficacy

    Time frame: Six weeks after baseline (T6)

    Self-efficacy subscale Me as a Parent . Higher scores indicate more self-efficacy.

  13. Parental self-efficacy

    Time frame: Twelve weeks after baseline (T12, follow-up)

    Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy.

  14. Parental anxiety change expectancy

    Time frame: Baseline (T0)

    Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.

  15. Parental anxiety change expectancy

    Time frame: Two weeks after baseline (T2)

    Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.

  16. Parental anxiety change expectancy

    Time frame: Four weeks after baseline (T4)

    Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.

  17. Parental anxiety change expectancy

    Time frame: Six weeks after baseline (T6)

    Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.

  18. Parental anxiety change expectancy

    Time frame: Twelve weeks after baseline (T12, follow-up)

    Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy.

  19. Parent-child interactions

    Time frame: Baseline (T0)

    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.

  20. Parent-child interactions

    Time frame: Six weeks after baseline (T6)

    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.

  21. Parent-child interactions

    Time frame: Twelve weeks after baseline (T12, follow-up)

    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.

  22. Clinician rated child anxiety

    Time frame: Baseline (T0)

    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.

  23. Clinician rated child anxiety

    Time frame: Six weeks after baseline (T6)

    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.

  24. Clinician rated child anxiety

    Time frame: Twelve weeks after baseline (T12, follow-up)

    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.

Sponsors and collaborators

Lead sponsor

University of Amsterdam

Other

Collaborators

  • Netherlands Organisation for Scientific Research

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 11, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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