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| Name | Class |
|---|---|
| Netherlands Organisation for Scientific Research | OTHER_GOV |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Child Life impairment | Child Anxiety Life Interference Scale . Higher scores indicate more life interference. | Baseline (T0) |
| Child Life impairment | Child Anxiety Life Interference Scale. Higher scores indicate more life interference. |
| Measure | Description | Time Frame |
|---|---|---|
| Child general mental health | Behavior and Feeling Survey (anxiety scale omitted). Higher scores indicate worse mental health. | Baseline (T0) |
| Child general mental health | Behavior and Feeling Survey (anxiety scale omitted). Higher scores indicate worse mental health. |
Inclusion Criteria:
Exclusion Criteria:
None
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| Name | Affiliation | Role |
|---|---|---|
| Karen Rienks, MSc | University of Amsterdam | Principal Investigator |
| Patty Leijten, Dr | University of Amsterdam | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Amsterdam | Amsterdam | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19230863 | Background | 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. | |
| 24135256 | Background | 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. |
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Fully anonymized data will be publicly shared after publication of the project results.
After publication of project results
Via UvA Figshare data can be stored and shared on request. Requests are considered by the study officials. Together they decide whether anonymised data can be shared with a third party.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000088686 | Cognitive Restructuring |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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A Factorial Experiment with 34 conditions
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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.
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
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| 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. |
|
| 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. |
|
| 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. |
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| 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. |
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
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| 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. |
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| 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. |
|
| 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. |
|
| 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. |
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| 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. |
|
| 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. |
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| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
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| 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. |
|
| 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. |
|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Two weeks after baseline (T2) |
| Child Life impairment | Child Anxiety Life Interference Scale. Higher scores indicate more life interference. | Four weeks after baseline (T4) |
| Child Life impairment | Child Anxiety Life Interference Scale. Higher scores indicate more life interference. | Six weeks after baseline (T6) |
| Child Life impairment | Child Anxiety Life Interference Scale. Higher scores indicate more life interference. | Twelve weeks after baseline (T12, follow-up) |
| Family Accommodation | Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation. | Baseline (T0) |
| Family Accommodation | Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation. | Two weeks after baseline (T2) |
| Family Accommodation | Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation. | Four weeks after baseline (T4) |
| Family Accommodation | Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation. | Six weeks after baseline (T6) |
| Family Accommodation | Family Accommodation Scale - Anxiety. Higher scores indicate more family accommodation. | 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. | Baseline (T0) |
| Parental Empathetic Reactions to Child Anxiety | Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy. | Two weeks after baseline (T2) |
| Parental Empathetic Reactions to Child Anxiety | Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy. | Four weeks after baseline (T4) |
| Parental Empathetic Reactions to Child Anxiety | Questionnaire loosely based on the Empathy Formative Questionnaire. Higher scores indicate more empathy. | Six weeks after baseline (T6) |
| 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) |
| Parental Cognitions about Child Anxiety | Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions. | Baseline (T0) |
| Parental Cognitions about Child Anxiety | Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions. | Two weeks after baseline (T2) |
| Parental Cognitions about Child Anxiety | Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions. | Four weeks after baseline (T4) |
| Parental Cognitions about Child Anxiety | Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions. | Six weeks after baseline (T6) |
| Parental Cognitions about Child Anxiety | Parental Beliefs About Anxiety Questionnaire. Higher scores indicate more maladaptive cognitions. | Twelve weeks after baseline (T12, follow-up) |
| Six weeks after baseline (T6) |
| Child general mental health | Behavior and Feeling Survey (anxiety scale omitted). Higher scores indicate worse mental health. | Twelve weeks after baseline (T12, follow-up) |
| Parental Anxiety | Anxiety subscale DASS-21. Higher scores indicate more parental anxiety. | Baseline (T0) |
| Parental Anxiety | Anxiety subscale DASS-21. Higher scores indicate more parental anxiety. | Two weeks after baseline (T2) |
| Parental Anxiety | Anxiety subscale DASS-21. Higher scores indicate more parental anxiety. | Four weeks after baseline (T4) |
| Parental Anxiety | Anxiety subscale DASS-21. Higher scores indicate more parental anxiety. | Six weeks after baseline (T6) |
| Parental Anxiety | Anxiety subscale DASS-21 | Twelve weeks after baseline (T12, follow-up) |
| Parental self-efficacy | Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy. | Baseline (T0) |
| Parental self-efficacy | Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy. | Two weeks after baseline (T2) |
| Parental self-efficacy | Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy. | Four weeks after baseline (T4) |
| Parental self-efficacy | Self-efficacy subscale Me as a Parent . Higher scores indicate more self-efficacy. | Six weeks after baseline (T6) |
| Parental self-efficacy | Self-efficacy subscale Me as a Parent. Higher scores indicate more self-efficacy. | Twelve weeks after baseline (T12, follow-up) |
| Parental anxiety change expectancy | Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy. | Baseline (T0) |
| Parental anxiety change expectancy | Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy. | Two weeks after baseline (T2) |
| Parental anxiety change expectancy | Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy. | Four weeks after baseline (T4) |
| Parental anxiety change expectancy | Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy. | Six weeks after baseline (T6) |
| Parental anxiety change expectancy | Variation on the Anxiety Change Expectancy Scale. Higher scores indicate more change expectancy. | Twelve weeks after baseline (T12, follow-up) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
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