Intervention Social Anxiety: Combining Parent-child Treatment

NCT06352463 | Recruiting DMC

• 1 other identifier: 406.XS.03.068
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

Conditions

Social Anxiety Disorder of Childhood

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Change in anxiety-related symptoms and family accommodation

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

Study Arms (3)

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.

Other: Denken + Doen = Durven; Other: Supportive Parenting for Anxious Childhood Emotions

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.

Other: Denken + Doen = Durven; Other: Supportive Parenting for Anxious Childhood Emotions

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.

Other: Denken + Doen = Durven; Other: Supportive Parenting for Anxious Childhood Emotions

Interventions

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.

Also known as: DDD

2-week waiting period; 4-week waiting period; 6-week waiting period

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.

Also known as: SPACE

2-week waiting period; 4-week waiting period; 6-week waiting period

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Leiden University: lead
• Leids Universitair Behandel en Expertise Centrum (LUBEC): collaborator
• GGZ Delfland: collaborator
• Netherlands Organisation for Scientific Research: collaborator

Study Sites (3)

GGZ Delfland

Delft, South Holland, 2600GA, Netherlands

NOT YET RECRUITING

Leiden University

Leiden, South Holland, 2333AK, Netherlands

RECRUITING

LUBEC

Leiden, South Holland, 2333ZB, Netherlands

RECRUITING

Related Publications (15)

• 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.

  PMID: 23995026 BACKGROUND

• 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.

  PMID: 19363188 BACKGROUND

• 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.

  PMID: 35325683 BACKGROUND

• 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.

  PMID: 27213722 BACKGROUND

• 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.

  PMID: 30527785 BACKGROUND

• 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.

  PMID: 29253607 BACKGROUND

• 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.

  PMID: 22965863 BACKGROUND

• 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.

  PMID: 30851397 BACKGROUND

• 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.

  PMID: 26238937 BACKGROUND

• 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.

  PMID: 35987298 BACKGROUND

• 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.

  PMID: 27399932 BACKGROUND

• 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.

  PMID: 27406470 BACKGROUND

• 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.

  BACKGROUND

• Albano, A. M. & Silverman, W. K. (2022). Anxiety and related disorders interview schedule for DSM-5 (ADIS-5-PV). Oxford University Press, USA.

  BACKGROUND

• van Steensel (2023). Database effective youth interventions: description 'Denken + Doen = Durven'. Utrecht: Nederlands Jeugdinstituut. Downloaded from www.nji.nl/jeugdinterventies.

  BACKGROUND

MeSH Terms

Interventions

Dichlorodiphenyldichloroethane

Intervention Hierarchy (Ancestors)

Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Study Officials

• Anke M Klein, AS

  Leiden University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anke M Klein, AS

CONTACT

+31655111908; a.m.klein@fsw.leidenuniv.nl

Anika Bexkens, AS

CONTACT

+31715276566; a.bexkens@fsw.leidenuniv.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 8, 2024
• Study Start: August 6, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)