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NCT Number: NCT06352463

Intervention Social Anxiety: Combining Parent-child Treatment

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.

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Key information

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GGZ Delfland, Delft, South Holland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Denken + Doen = Durven

Other

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

Supportive Parenting for Anxious Childhood Emotions

Other

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

Primary outcomes

  1. 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

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anika Bexkens, AS

CONTACT

[email protected]

+31715276566

Anke M Klein, AS

CONTACT

[email protected]

+31655111908

Sponsors and collaborators

Lead sponsor

Leiden University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: ISA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 8, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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