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Clinical Trials/NCT06352463
NCT06352463RecruitingNot Applicable

More Than the Sum of Its Parts: Investigating a Combined Parent-child Treatment for Children With Social Anxiety

Leiden University3 sites in 1 country9 target enrollmentStarted: August 6, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
9
Locations
3
Primary Endpoint
Change in severity of social anxiety in children

Study Overview

Brief Summary

The aim of this pilot project is to investigate a treatment program for children with social anxiety, in which children and their parents, parallel to each other, follow separate evidence-based interventions. The added value of this pilot project is that the investigators are examining how both programs interact when offered simultaneously.

Detailed Description

After a diagnostic trajectory and a 2-week reflection period, children and their parents are invited to come into the lab for baseline 1. During baseline 1, children and their parents will be interviewed and they will fill in some questionnaires. They will then be randomly assigned to a 2-, 4-, or 6-week waiting period. During this waiting period they will fill in Experience Sampling Method (ESMs) daily, every other week. One week before the end of the waiting period, baseline 2 will take place. After the waiting period children and their parents will start their separate treatments in parallel. Children will get an individually tailored cognitive behavioural therapy (CBT)-protocol for social anxiety and parents will get SPACE. In the treatment period, they will fill in ESMs daily. There is another assessment with interviews and questionnaires at mid-treatment (after 6 sessions) and post-treatment (after 12 sessions), as well as 1- and 2-months after treatment has ended. After the treatment period, the frequency of the ESMs will go back to daily every other week.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
8 Years to 16 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosis social anxiety
  • •At least 1 parent is willing to participate

Exclusion Criteria

  • •Currently under treatment for anxiety
  • •Other complaints that need attention first
  • •Not understanding instructions/treatment

Arms & Interventions

2-week waiting period

Active Comparator

Children and parents have to wait 2 weeks between baseline 1 and the start of the treatment. In the first week, they fill in ESMs daily.

Intervention: Supportive Parenting for Anxious Childhood Emotions (Other)

2-week waiting period

Active Comparator

Children and parents have to wait 2 weeks between baseline 1 and the start of the treatment. In the first week, they fill in ESMs daily.

Intervention: Denken + Doen = Durven (Other)

4-week waiting period

Active Comparator

Children and parents have to wait 4 weeks between baseline 1 and the start of the treatment. In the first and third week, they fill in ESMs daily.

Intervention: Denken + Doen = Durven (Other)

4-week waiting period

Active Comparator

Children and parents have to wait 4 weeks between baseline 1 and the start of the treatment. In the first and third week, they fill in ESMs daily.

Intervention: Supportive Parenting for Anxious Childhood Emotions (Other)

6-week waiting period

Active Comparator

Children and parents have to wait 6 weeks between baseline 1 and the start of the treatment. In the first, third, and fifth week, they fill in ESMs daily.

Intervention: Denken + Doen = Durven (Other)

6-week waiting period

Active Comparator

Children and parents have to wait 6 weeks between baseline 1 and the start of the treatment. In the first, third, and fifth week, they fill in ESMs daily.

Intervention: Supportive Parenting for Anxious Childhood Emotions (Other)

Outcomes

Primary Outcomes

Change in severity of social anxiety in children

Time Frame: From baseline to the end of treatment and follow-up (1 and 2 months post-treatment)

Severity of social anxiety will be assessed using the Anxiety Disorder Interview Schedule (ADIS-V), which will provide a clinician severity rating (CSR)-score. This is a score between 0 and 8, with higher scores indicating a higher severity and interference of anxiety. The ADIS-V will be administered to children and parents.

Secondary Outcomes

  • Change in anxiety-related symptoms and family accommodation(From baseline to the end of treatment and follow-up (1 and 2 months post-treatment))

Investigators

Sponsor
Leiden University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Anke M Klein, AS

Principal Investigator

Leiden University

Study Sites (3)

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