RecruitingACTRN12623000907640

A digital anxiety intervention for children with reading difficulties

A randomised controlled trial of the efficacy of a digital anxiety intervention for children with reading difficulties and anxiety

Sponsor

University of New South Wales

Enrollment

86 participants

Start Date

Oct 24, 2023

Study Type

Interventional

Conditions

Reading difficulties Anxiety

Summary

The overall goal of this research is to evaluate the efficacy of a digital anxiety intervention developed for children with poor reading. We are aiming to answer the following research question: Does a digital anxiety intervention modified for children with poor reading significantly reduce anxiety symptoms and result in greater remission of anxiety for children aged 7 to 12 years compared to the control condition? We aim to evaluate this through a randomised controlled trial (RCT) with a primary timepoint (post-intervention) at 12 weeks, an interim timepoint (mid-intervention) at 5 weeks, and a secondary timepoint (follow-up) at 24 weeks. We hypothesise that the intervention will significantly improve children's anxiety.

Eligibility

Sex: Both males and femalesMin Age: 7 Yearss

Inclusion Criteria5

Children aged 7-12 years in Australia
Reading level -1 standard deviation (SD) below average on (1) one or more word lists from the Castles and Coltheart Reading test (CC2; regular, irregular or nonword lists) and/or (2) the nonword or irregular word list from the Test Of Word Reading Efficiency (TOWRE)
Diagnosis of (1) any anxiety disorder based on the DSM-5-TR (i.e. social anxiety disorder, separation anxiety disorder, generalised anxiety disorder, panic disorder, agoraphobia, specific phobia or unspecified anxiety disorder) and/or (2) obsessive compulsive disorder assessed using the ADIS-V.
Normal or corrected to normal vision and hearing (parent self-report)
Willingness to give written informed consent (verbal student assent) and willingness to participate to and comply with the study.

Exclusion Criteria4

A diagnosis of Autism Spectrum Disorder (as determined by parent self-report) and/or Intellectual Developmental Disorder (IQ < 75; as determined by parent-self report)
A diagnosis of one or more of the following disorders if these disorders are the primary concern beyond anxiety: Oppositional Defiant Disorder (as determined by ADIS-V or parent self-report), Conduct Disorder (as determined by ADIS-V or parent self-report), Major Depressive Disorder (as determined by parent self-report or ADIS-V) and/or neurological condition (e.g. Epilepsy; as determined by parent self-report)
Current life-threating suicidal ideation and/or had serious suicidal ideation in the past month (as determined through parent self-report).
Currently receiving one-on-one therapy for anxiety with a psychologist, psychiatrist or paediatrician frequently (i.e. more frequently than once every 2 months)

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Interventions

The digital anxiety intervention is a web-based and clinician-led program that delivers Cognitive Behavioural Therapy (CBT). The intervention was developed given that reading difficulties and anxiety

The digital anxiety intervention is a web-based and clinician-led program that delivers Cognitive Behavioural Therapy (CBT). The intervention was developed given that reading difficulties and anxiety tend to co-occur and become a vicious cycle. These children tend to struggle with understanding content of existing digital anxiety interventions as they tend to be text heavy. A team of leading researchers in the field of anxiety and reading, and user experience specialists worked collaboratively via co-design process. The co-design process involved 3 x 1-hour semi-structured interviews and 2 x 2-hour workshops (N=18; n=8 parents, n=6 children and n=4 clinicians). Researchers, clinicians and user experience specialists discussed findings from the qualitative methods to design the intervention accessible for children with reading difficulties and anxiety. The intervention is an exposure-focused program which aims to teach children strategies to manage their anxiety. The intervention includes strategies such as gradual exposure, psychoeducation, and cognitive restructuring. The intervention will be delivered on google-classrooms and includes videos and worksheets. Children will be guided through the digital anxiety intervention with the clinician (Provisional or Registered Psychologist) via telehealth (one-on-one video calls) for 1 x 60-minute session per week for 10 weeks. The intervention will be delivered by psychologists who are co-investigators on this study. They will have experience in working with children and delivering CBT. Psychologists will be provided with a 1 hour training and orientation session to provide them details about the study and intervention, and orient them to the therapist manual which was designed specifically for this study and provides them with a structured plan for each session. The intervention has optional strategies that the psychologist will deliver where appropriate (e.g. self-concept, calm breathing) based on baseline measures and clinical judgement. Parents will independently work through approximately 30-min x 3 weeks of material at weeks 1, 5 and 10 which will include psychoeducation and strategies to support their children through the intervention. They will also have 3 x 30-minute sessions (at weeks 1, 5 and 10) with the clinician to help support their child. Parents will be asked to organise a private space for themselves during the session (i.e. without the child present). These calls aim to reiterate key points of the intervention (e.g. treatment rationale, expectations around progress, positive reinforcement) and problem solve any barriers. We will select 20% of psychologist-child sessions to be transcribed and analysed for treatment integrity by independent clinicians.