Intervention Social Anxiety: Combining Parent-child Treatment (ISA)

April 2, 2024 updated by: Anke M Klein, AS, Leiden University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • South-Holland
      • Delft, South-Holland, Netherlands, 2600GA
      • Leiden, South-Holland, Netherlands, 2333AK
        • Recruiting
        • Leiden University
      • Leiden, South-Holland, Netherlands, 2333ZB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2-week waiting period
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.
Other: Denken + Doen = Durven
DDD is an evidence based cognitive behavioural therapy (CBT)-treatment protocol for children with anxiety. This research will use the modular version of DDD, which means that the therapist will decide which modules she will use based on the specific symptoms and needs of the child. DDD consists of four parts. First, there will be psycho education in which the child learns about how anxiety can arise, when anxiety is normal, and how thoughts, emotions, and behaviour are linked. Second, the child will learn coping strategies for dealing with anxiety. Third, there will be cognitive restructuring by which that the child will learn skills to deal with anxious and negative thoughts, through challenging and experimenting. Finally, there will be exposure. In the exposure sessions, the child will face their fears step by step.
Other Names:
  • DDD
Other: Supportive Parenting for Anxious Childhood Emotions
Parents will follow the SPACE program. SPACE is a theory driven, evidence-based treatment program of 12 sessions. In a structured way, parents are trained to change their own behaviour as a reaction to the symptoms of their child. First, they are trained to recognise family accommodation and slowly reduce this. Second, this program focuses on the increase in supportive reactions from parents. They are taught to accept the child's feelings, fears, and problems and to trust in the ability of the child to cope with and tolerate anxiety-related problems. These two goals are attained via a sequence of steps in the SPACE manual. Furthermore, SPACE includes additional modules that can be implemented if needed. These provide tools for conquering communal challenges that can arise during the treatment process, including dealing with extremely disruptive behaviour of children and improving parental collaboration.
Other Names:
  • SPACE
Active Comparator: 4-week waiting period
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.
Other: Denken + Doen = Durven
DDD is an evidence based cognitive behavioural therapy (CBT)-treatment protocol for children with anxiety. This research will use the modular version of DDD, which means that the therapist will decide which modules she will use based on the specific symptoms and needs of the child. DDD consists of four parts. First, there will be psycho education in which the child learns about how anxiety can arise, when anxiety is normal, and how thoughts, emotions, and behaviour are linked. Second, the child will learn coping strategies for dealing with anxiety. Third, there will be cognitive restructuring by which that the child will learn skills to deal with anxious and negative thoughts, through challenging and experimenting. Finally, there will be exposure. In the exposure sessions, the child will face their fears step by step.
Other Names:
  • DDD
Other: Supportive Parenting for Anxious Childhood Emotions
Parents will follow the SPACE program. SPACE is a theory driven, evidence-based treatment program of 12 sessions. In a structured way, parents are trained to change their own behaviour as a reaction to the symptoms of their child. First, they are trained to recognise family accommodation and slowly reduce this. Second, this program focuses on the increase in supportive reactions from parents. They are taught to accept the child's feelings, fears, and problems and to trust in the ability of the child to cope with and tolerate anxiety-related problems. These two goals are attained via a sequence of steps in the SPACE manual. Furthermore, SPACE includes additional modules that can be implemented if needed. These provide tools for conquering communal challenges that can arise during the treatment process, including dealing with extremely disruptive behaviour of children and improving parental collaboration.
Other Names:
  • SPACE
Active Comparator: 6-week waiting period
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.
Other: Denken + Doen = Durven
DDD is an evidence based cognitive behavioural therapy (CBT)-treatment protocol for children with anxiety. This research will use the modular version of DDD, which means that the therapist will decide which modules she will use based on the specific symptoms and needs of the child. DDD consists of four parts. First, there will be psycho education in which the child learns about how anxiety can arise, when anxiety is normal, and how thoughts, emotions, and behaviour are linked. Second, the child will learn coping strategies for dealing with anxiety. Third, there will be cognitive restructuring by which that the child will learn skills to deal with anxious and negative thoughts, through challenging and experimenting. Finally, there will be exposure. In the exposure sessions, the child will face their fears step by step.
Other Names:
  • DDD
Other: Supportive Parenting for Anxious Childhood Emotions
Parents will follow the SPACE program. SPACE is a theory driven, evidence-based treatment program of 12 sessions. In a structured way, parents are trained to change their own behaviour as a reaction to the symptoms of their child. First, they are trained to recognise family accommodation and slowly reduce this. Second, this program focuses on the increase in supportive reactions from parents. They are taught to accept the child's feelings, fears, and problems and to trust in the ability of the child to cope with and tolerate anxiety-related problems. These two goals are attained via a sequence of steps in the SPACE manual. Furthermore, SPACE includes additional modules that can be implemented if needed. These provide tools for conquering communal challenges that can arise during the treatment process, including dealing with extremely disruptive behaviour of children and improving parental collaboration.
Other Names:
  • SPACE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to the end of treatment and follow-up (1 and 2 months post-treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in anxiety-related symptoms and family accommodation
Time Frame: From baseline to the end of treatment and follow-up (1 and 2 months post-treatment)
Children and their parents will fill in a daily experience sampling method (ESM) on their phone to measure thoughts, emotions, and behaviours in the flow of daily life. Children are asked 3 questions, each on a scale from 0 to 8. This sums up to a score between 0 and 24 each day for children. Parents are asked 7 questions which they answer on a scale between 0 and 4, resulting in a score between 0 and 28 each day for parents. Higher scores indicate more anxiety-related symptoms and family accommodation.
From baseline to the end of treatment and follow-up (1 and 2 months post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leiden University

Collaborators

Netherlands Organisation for Scientific Research
GGZ Delfland
Leids Universitair Behandel en Expertise Centrum (LUBEC)

Investigators

  • Principal Investigator: Anke M Klein, AS, Leiden University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 406.XS.03.068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators will share the data upon request, but only for specific purposes. In addition, the data needs to be deleted after use. The investigators will not share data that cannot be anonymised, such as the video data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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