Internet-assisted cognitive behavioural therapy with telephone coaching for anxious Finnish children aged 10-13 years: study protocol for a randomised controlled trial

Terhi Luntamo, Tarja Korpilahti-Leino, Terja Ristkari, Sanna Hinkka-Yli-Salomäki, Marjo Kurki, Atte Sinokki, Kaisa Lamminen, Kristiina Saanakorpi, Susanna Saarinen, Marjukka Maunuksela, Saana Sourander, Katja Toivonen, Anna Zadkova, Miia Suilamo, Linda Casagrande, Johanna Palmroth, A Sourander, Terhi Luntamo, Tarja Korpilahti-Leino, Terja Ristkari, Sanna Hinkka-Yli-Salomäki, Marjo Kurki, Atte Sinokki, Kaisa Lamminen, Kristiina Saanakorpi, Susanna Saarinen, Marjukka Maunuksela, Saana Sourander, Katja Toivonen, Anna Zadkova, Miia Suilamo, Linda Casagrande, Johanna Palmroth, A Sourander

Abstract

Introduction: Childhood anxiety is common, causes significant functional impairment and may lead to psychosocial problems by adulthood. Although cognitive behavioural therapy (CBT) is effective for treating anxiety, its availability is limited by the lack of trained CBT therapists and easily accessible local services. To address the challenges in both recognition and treatment, this study combines systematic anxiety screening in the general population with a randomised controlled trial (RCT) on internet-assisted CBT (ICBT) with telephone coaching. Child, family and intervention-related factors are studied as possible predictors or moderators, together with the COVID-19 pandemic.

Methods and analysis: The study is an open two-parallel group RCT, stratified by sex, that compares ICBT with telephone coaching to an education control. Children aged 10-13 are screened at yearly school healthcare check-ups using five items from the Screen for Child Anxiety Related Disorders (SCARED) Questionnaire. The families of children who screen positive for anxiety are contacted to assess the family's eligibility for the RCT. The inclusion criteria include scoring at least 22 points in the 41-item SCARED Questionnaire. The primary outcome is the SCARED child and parent reports. The secondary outcomes include the impact of anxiety, quality of life, comorbidity, peer relationships, perceptions of school, parental well-being and service use. Additional measures include demographics and life events, anxiety disorder diagnoses, as well as therapeutic partnerships, the use of the programme and general satisfaction among the intervention group.

Ethics and dissemination: The study has been approved by the research ethics board of the Hospital District of South West Finland and local authorities. Participation is voluntary and based on informed consent. The anonymity of the participants will be protected and the results will be published in a scientific journal and disseminated to healthcare professionals and the general public.

Trial registration number: ClinicalTrials.gov NCT03310489, pre-results, initially released on 30 September 2017.

Keywords: anxiety disorders; child & adolescent psychiatry; clinical trials; preventive medicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart of the planned study. ICBT, internet-assisted cognitive behavioural therapy; SCARED, Screen for Child Anxiety Related Disorders.
Figure 2
Figure 2
Animated video bloggers, ‘Mimosa’ has a specific phobia and ‘Anton’ has a social phobia. They talk about their anxieties and provide peer support for the children using the programme.
Figure 3
Figure 3
An animated character called Doctor Wunderman provides psychoeducation about anxiety and fears, adapted to the child’s developmental stage.
Figure 4
Figure 4
The children and parents work together to plan the ladders for the child’s stepwise progress towards the most feared and avoided situations.

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