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

University of Amsterdam

Status: Not yet enrolling

Conditions: Anxiety

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05854602

VI.Vidi.201.065 - Study 5

Details and patient eligibility

About

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.

Enrollment: 266 estimated patients

Sex: All

Ages: 7 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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266 participants in 34 patient groups

Condition 1: 000

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Behavioral: Component A

Condition 3: 00A

Experimental group

Description:

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.

Treatment:

Behavioral: Component A

Condition 4: 0AB

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component A

Condition 5: 0AC

Experimental group

Description:

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.

Treatment:

Behavioral: Component A

Behavioral: Component C

Condition 6: 0B0

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Condition 7: 00B

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Condition 8: 0BA

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component A

Condition 9: 0BC

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component C

Condition 10: 0C0

Experimental group

Description:

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.

Treatment:

Behavioral: Component C

Condition 11: 00C

Experimental group

Description:

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.

Treatment:

Behavioral: Component C

Condition 12: 0CA

Experimental group

Description:

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.

Treatment:

Behavioral: Component A

Behavioral: Component C

Condition 13: 0CB

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component C

Condition 14: A00

Experimental group

Description:

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.

Treatment:

Behavioral: Component A

Condition 15: A0B

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component A

Condition 16: A0C

Experimental group

Description:

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.

Treatment:

Behavioral: Component A

Behavioral: Component C

Condition 17: AB0

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component A

Condition 18: ABC

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component A

Behavioral: Component C

Condition 19: AC0

Experimental group

Description:

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.

Treatment:

Behavioral: Component A

Behavioral: Component C

Condition 20: ACB

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component A

Behavioral: Component C

Condition 21: B00

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Condition 22: B0A

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component A

Condition 23: B0C

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component C

Condition 24: BA0

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component A

Condition 25: BAC

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component A

Behavioral: Component C

Condition 26: BC0

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component C

Condition 27: BCA

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component A

Behavioral: Component C

Condition 28: C00

Experimental group

Description:

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.

Treatment:

Behavioral: Component C

Condition 29: C0A

Experimental group

Description:

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.

Treatment:

Behavioral: Component A

Behavioral: Component C

Condition 30: C0B

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component C

Condition 31: CA0

Experimental group

Description:

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.

Treatment:

Behavioral: Component A

Behavioral: Component C

Condition 32: CAB

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component A

Behavioral: Component C

Condition 33: CB0

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component C

Condition 34: CBA

Experimental group

Description:

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.

Treatment:

Behavioral: Component B

Behavioral: Component A

Behavioral: Component C