The Relative Effects of Three Parent-Intervention Components to Reduce Children's Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Child Anxiety
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 7 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Condition 2: 0A0
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.
干预措施: Component A (Behavioral)
Condition 3: 00A
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.
干预措施: Component A (Behavioral)
Condition 4: 0AB
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.
干预措施: Component B (Behavioral)
Condition 4: 0AB
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.
干预措施: Component A (Behavioral)
Condition 5: 0AC
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.
干预措施: Component C (Behavioral)
Condition 5: 0AC
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.
干预措施: Component A (Behavioral)
Condition 6: 0B0
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.
干预措施: Component B (Behavioral)
Condition 7: 00B
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.
干预措施: Component B (Behavioral)
Condition 8: 0BA
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.
干预措施: Component A (Behavioral)
Condition 8: 0BA
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.
干预措施: Component B (Behavioral)
Condition 9: 0BC
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.
干预措施: Component B (Behavioral)
Condition 9: 0BC
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.
干预措施: Component C (Behavioral)
Condition 10: 0C0
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.
干预措施: Component C (Behavioral)
Condition 11: 00C
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.
干预措施: Component C (Behavioral)
Condition 12: 0CA
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.
干预措施: Component A (Behavioral)
Condition 12: 0CA
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.
干预措施: Component C (Behavioral)
Condition 13: 0CB
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.
干预措施: Component B (Behavioral)
Condition 13: 0CB
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.
干预措施: Component C (Behavioral)
Condition 14: A00
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.
干预措施: Component A (Behavioral)
Condition 15: A0B
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.
干预措施: Component A (Behavioral)
Condition 15: A0B
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.
干预措施: Component B (Behavioral)
Condition 16: A0C
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.
干预措施: Component A (Behavioral)
Condition 16: A0C
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.
干预措施: Component C (Behavioral)
Condition 17: AB0
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.
干预措施: Component A (Behavioral)
Condition 17: AB0
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.
干预措施: Component B (Behavioral)
Condition 18: ABC
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.
干预措施: Component A (Behavioral)
Condition 18: ABC
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.
干预措施: Component B (Behavioral)
Condition 18: ABC
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.
干预措施: Component C (Behavioral)
Condition 19: AC0
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.
干预措施: Component A (Behavioral)
Condition 19: AC0
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.
干预措施: Component C (Behavioral)
Condition 20: ACB
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.
干预措施: Component A (Behavioral)
Condition 20: ACB
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.
干预措施: Component B (Behavioral)
Condition 20: ACB
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.
干预措施: Component C (Behavioral)
Condition 21: B00
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.
干预措施: Component B (Behavioral)
Condition 22: B0A
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.
干预措施: Component A (Behavioral)
Condition 22: B0A
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.
干预措施: Component B (Behavioral)
Condition 23: B0C
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.
干预措施: Component B (Behavioral)
Condition 23: B0C
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.
干预措施: Component C (Behavioral)
Condition 24: BA0
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.
干预措施: Component A (Behavioral)
Condition 24: BA0
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.
干预措施: Component B (Behavioral)
Condition 25: BAC
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.
干预措施: Component A (Behavioral)
Condition 25: BAC
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.
干预措施: Component B (Behavioral)
Condition 25: BAC
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.
干预措施: Component C (Behavioral)
Condition 26: BC0
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.
干预措施: Component B (Behavioral)
Condition 26: BC0
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.
干预措施: Component C (Behavioral)
Condition 27: BCA
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.
干预措施: Component A (Behavioral)
Condition 27: BCA
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.
干预措施: Component B (Behavioral)
Condition 27: BCA
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.
干预措施: Component C (Behavioral)
Condition 28: C00
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.
干预措施: Component C (Behavioral)
Condition 29: C0A
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.
干预措施: Component A (Behavioral)
Condition 29: C0A
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.
干预措施: Component C (Behavioral)
Condition 30: C0B
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.
干预措施: Component B (Behavioral)
Condition 30: C0B
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.
干预措施: Component C (Behavioral)
Condition 31: CA0
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.
干预措施: Component A (Behavioral)
Condition 31: CA0
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.
干预措施: Component C (Behavioral)
Condition 32: CAB
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.
干预措施: Component A (Behavioral)
Condition 32: CAB
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.
干预措施: Component B (Behavioral)
Condition 32: CAB
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.
干预措施: Component C (Behavioral)
Condition 33: CB0
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.
干预措施: Component B (Behavioral)
Condition 33: CB0
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.
干预措施: Component C (Behavioral)
Condition 34: CBA
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.
干预措施: Component A (Behavioral)
Condition 34: CBA
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.
干预措施: Component B (Behavioral)
Condition 1: 000
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 34: CBA
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.
干预措施: Component C (Behavioral)
结局指标
主要结局
Child Anxiety
时间窗: 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.
次要结局
- Child Life impairment(Twelve weeks after baseline (T12, follow-up))
- Parental Empathetic Reactions to Child Anxiety(Twelve weeks after baseline (T12, follow-up))
- Parental Cognitions about Child Anxiety(Twelve weeks after baseline (T12, follow-up))
- Family Accommodation(Twelve weeks after baseline (T12, follow-up))
研究者
Karen Rienks
PhD Candidate
University of Amsterdam