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Intervention Social Anxiety: Combining Parent-child Treatment

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06352463
Acronym
ISA
Enrollment
9
Registered
2024-04-08
Start date
2024-08-06
Completion date
2025-07-01
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Social Anxiety Disorder of Childhood

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.

Interventions

OTHERDenken + 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.

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.

Sponsors

Leids Universitair Behandel en Expertise Centrum (LUBEC)
CollaboratorUNKNOWN
GGZ Delfland
CollaboratorUNKNOWN
Netherlands Organisation for Scientific Research
CollaboratorOTHER_GOV
Leiden University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
8 Years to 16 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in severity of social anxiety in childrenFrom 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

MeasureTime frameDescription
Change in anxiety-related symptoms and family accommodationFrom 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.

Countries

Netherlands

Contacts

Primary ContactAnke M Klein, AS
a.m.klein@fsw.leidenuniv.nl+31655111908
Backup ContactAnika Bexkens, AS
a.bexkens@fsw.leidenuniv.nl+31715276566

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026