Intervention Social Anxiety: Combining Parent-child Treatment

Official title

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

Overview

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

• 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
• 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 c

Primary outcome measures

• 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)]

Secondary outcome measures (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)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Netherlands · 3 centers

• GGZ Delfland — Delft
• Leiden University — Leiden
• LUBEC — Leiden

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06352463 · 406.XS.03.068

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗