The Relative Effects of Three Parent-Intervention Components to Reduce Children's Anxiety
NCT05854602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266
Last updated 2026-05-05
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.
Conditions
Interventions
- 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.
- BEHAVIORAL
-
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.
- BEHAVIORAL
-
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.
Sponsors & Collaborators
-
Netherlands Organisation for Scientific Research
collaborator OTHER_GOV -
University of Amsterdam
lead OTHER
Principal Investigators
-
Karen Rienks, MSc · University of Amsterdam
-
Patty Leijten, Dr · University of Amsterdam
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 7 Years
- Max Age
- 11 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-01
- Primary Completion
- 2026-03-13
- Completion
- 2026-03-13
Countries
- Netherlands
Study Locations
More Related Trials
-
Effectiveness of Cognitive Behavioral Therapy (CBT) for Child Anxiety Disorders in Community Clinics in Norway
NCT00735995 ·Status: COMPLETED ·Phase: PHASE2
-
Comparative Effectiveness of Internet-based Versus Parent-Coached Cognitive-Behavioral Therapy For Children and Adolescents With Anxiety and OCD
NCT07024758 ·Status: RECRUITING ·Phase: NA
-
Novel Anxiety Treatment
NCT03790696 ·Status: COMPLETED ·Phase: NA
-
Selective Prevention of Anxiety Disorders in Children: A Parent Training Intervention for Anxious Parents
NCT02386410 ·Status: COMPLETED ·Phase: NA
-
SPACE: a Parent-based Treatment for Pediatric OCD
NCT06356090 ·Status: RECRUITING ·Phase: NA
-
Examining the Effects of Reduced Environmental Stimulation on Anxiety
NCT03051074 ·Status: COMPLETED ·Phase: NA
-
Effectiveness of a Family-Based Treatment for Preventing Anxiety Disorders in At-Risk Children
NCT00847561 ·Status: COMPLETED ·Phase: NA
-
Attention Bias Modification Treatment (ABMT) for Anxiety Disorders in Youth
NCT02460536 ·Status: COMPLETED ·Phase: NA
-
Treatment for Specific Phobias in Children
NCT00051220 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Facing Fears in Big or Smalls Steps?
NCT03688373 ·Status: COMPLETED ·Phase: NA
-
Brain Activity Changes After Cognitive Behavioral Therapy for Anxiety in Autistic Youth From High-Need Communities
NCT06904508 ·Status: RECRUITING ·Phase: NA
-
Modular Treatment for Preschool Anxiety
NCT02510391 ·Status: UNKNOWN ·Phase: NA
-
Brief, Remote Treatment of Youth Injection Phobia and Measurement of Novel, Disorder-congruent Cognitive Bias Tasks
NCT04972006 ·Status: UNKNOWN ·Phase: NA
-
Augmentation of Exposure Using Positive Mental Rehearsal in Individuals With Increased Social Anxiety
NCT06564402 ·Status: RECRUITING ·Phase: NA
-
Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot RCT
NCT05927987 ·Status: RECRUITING ·Phase: NA
-
Anxiety Disorders in Children - Association With Neurodevelopmental Delay/Disorder
NCT00553085 ·Status: COMPLETED
-
Attention Bias Modification Training in Youth With Subthreshold Impairing Anxiety
NCT02410967 ·Status: COMPLETED ·Phase: NA
-
Prevention of Childhood Anxiety Disorders in Offspring of Anxious Parents
NCT04722731 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Internet-delivered Cognitive Behavior Therapy (CBT) for Children Age 8-12 Years With Anxiety Disorders
NCT01533402 ·Status: COMPLETED ·Phase: NA
-
The Feasibility and Efficacy of a Two-week MCT Treatment of Anxiety Disorders in a Group Setting
NCT05402306 ·Status: UNKNOWN ·Phase: NA
-
Brief Group Psychotherapy for Anxiety and Depression
NCT04489641 ·Status: COMPLETED ·Phase: NA
-
Evaluation of Family-Based Behavioral Treatments for Youth With Anxiety and Obsessive-Compulsive Disorder
NCT05967468 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Stepped Care Treatment for Anxiety Resilience
NCT07228143 ·Status: RECRUITING ·Phase: NA
-
A Clinical Research Studying a Method of Intervention for Children Diagnosed With Anxiety Disorder: Attentional Bias Intervention
NCT00482820 ·Status: COMPLETED ·Phase: NA
-
A Pilot Study of Fear Extinction Learning in Anxious Youth
NCT03032926 ·Status: COMPLETED