NCT06352463|RecruitingDMC
Intervention Social Anxiety: Combining Parent-child Treatment
ISA
More Than the Sum of Its Parts: Investigating a Combined Parent-child Treatment for Children With Social Anxiety
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ISA
More Than the Sum of Its Parts: Investigating a Combined Parent-child Treatment for Children With Social Anxiety
Sponsor study identifier
interventional
9
1 country
3
Study Start
August 6, 2024
Actual (reported)Primary Completion
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 26, 2024
Actual (reported)April 8, 2024
Actual (reported)August 6, 2024
Actual (reported)July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in severity of social anxiety in children
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)
Change in anxiety-related symptoms and family accommodation
From baseline to the end of treatment and follow-up (1 and 2 months post-treatment)
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.
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.
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.
GGZ Delfland
Delft, South Holland, 2600GA, Netherlands
Leiden University
Leiden, South Holland, 2333AK, Netherlands
LUBEC
Leiden, South Holland, 2333ZB, Netherlands
First MB. Diagnostic and statistical manual of mental disorders, 5th edition, and clinical utility. J Nerv Ment Dis. 2013 Sep;201(9):727-9. doi: 10.1097/NMD.0b013e3182a2168a. No abstract available.
Bulte I, Onghena P. Randomization tests for multiple-baseline designs: an extension of the SCRT-R package. Behav Res Methods. 2009 May;41(2):477-85. doi: 10.3758/BRM.41.2.477.
Craske MG, Treanor M, Zbozinek TD, Vervliet B. Optimizing exposure therapy with an inhibitory retrieval approach and the OptEx Nexus. Behav Res Ther. 2022 May;152:104069. doi: 10.1016/j.brat.2022.104069. Epub 2022 Mar 15.
Anke M Klein, AS
Leiden University
First Submitted
March 26, 2024
First Posted
April 8, 2024
Study Start
August 6, 2024
Actual (reported)Primary Completion
July 1, 2025
Estimated (date passed)Using Virtual Reality in Exposure-Based Treatment for Social Anxiety in Youth
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Kagan ER, Peterman JS, Carper MM, Kendall PC. ACCOMMODATION AND TREATMENT OF ANXIOUS YOUTH. Depress Anxiety. 2016 Sep;33(9):840-7. doi: 10.1002/da.22520. Epub 2016 May 23.
Kazdin AE. Single-case experimental designs. Evaluating interventions in research and clinical practice. Behav Res Ther. 2019 Jun;117:3-17. doi: 10.1016/j.brat.2018.11.015. Epub 2018 Dec 2.
Krasny-Pacini A, Evans J. Single-case experimental designs to assess intervention effectiveness in rehabilitation: A practical guide. Ann Phys Rehabil Med. 2018 May;61(3):164-179. doi: 10.1016/j.rehab.2017.12.002. Epub 2017 Dec 15.
Lebowitz ER, Woolston J, Bar-Haim Y, Calvocoressi L, Dauser C, Warnick E, Scahill L, Chakir AR, Shechner T, Hermes H, Vitulano LA, King RA, Leckman JF. Family accommodation in pediatric anxiety disorders. Depress Anxiety. 2013 Jan;30(1):47-54. doi: 10.1002/da.21998. Epub 2012 Sep 10.
Lebowitz ER, Marin C, Martino A, Shimshoni Y, Silverman WK. Parent-Based Treatment as Efficacious as Cognitive-Behavioral Therapy for Childhood Anxiety: A Randomized Noninferiority Study of Supportive Parenting for Anxious Childhood Emotions. J Am Acad Child Adolesc Psychiatry. 2020 Mar;59(3):362-372. doi: 10.1016/j.jaac.2019.02.014. Epub 2019 Mar 7.
Norman KR, Silverman WK, Lebowitz ER. Family Accommodation of Child and Adolescent Anxiety: Mechanisms, Assessment, and Treatment. J Child Adolesc Psychiatr Nurs. 2015 Aug;28(3):131-40. doi: 10.1111/jcap.12116. Epub 2015 Aug 4.
Rapee RM, McLellan LF, Carl T, Trompeter N, Hudson JL, Jones MP, Wuthrich VM. Comparison of Transdiagnostic Treatment and Specialized Social Anxiety Treatment for Children and Adolescents With Social Anxiety Disorder: A Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2023 Jun;62(6):646-655. doi: 10.1016/j.jaac.2022.08.003. Epub 2022 Aug 17.
Scaini S, Belotti R, Ogliari A, Battaglia M. A comprehensive meta-analysis of cognitive-behavioral interventions for social anxiety disorder in children and adolescents. J Anxiety Disord. 2016 Aug;42:105-12. doi: 10.1016/j.janxdis.2016.05.008. Epub 2016 Jun 25.
Spence SH, Rapee RM. The etiology of social anxiety disorder: An evidence-based model. Behav Res Ther. 2016 Nov;86:50-67. doi: 10.1016/j.brat.2016.06.007. Epub 2016 Jul 1.
Force, T. (1995). Task Force on Promotion and Dissemination of Psychological Procedures. Training in and dissemination of empirically-validated treatments: report and recommendations. The Clinical Psychologist, 48(1), 3-23.
Albano, A. M. & Silverman, W. K. (2022). Anxiety and related disorders interview schedule for DSM-5 (ADIS-5-PV). Oxford University Press, USA.
van Steensel (2023). Database effective youth interventions: description 'Denken + Doen = Durven'. Utrecht: Nederlands Jeugdinstituut. Downloaded from www.nji.nl/jeugdinterventies.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 1, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 15, 2024
Record last verified: 2024-10
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.
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Source: ClinicalTrials.gov.
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