Condition category
Mental and Behavioural Disorders
Date applied
28/03/2019
Date assigned
02/04/2019
Last edited
05/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Large-scale studies containing over 4000 participants aged 14 and under have indicated a high prevalence of anxiety (24% - including sub-threshold anxiety) and depression. In Ireland, recent evidence indicates that over 30% of Irish adolescents experience levels of anxiety and depression outside of a normal range. Similarly, it is estimated that by the age of 13, 1 in 3 young people in Ireland are likely to have experienced some type of mental disorder. Accordingly, anxiety and depression represent a significant public mental health issue.

Presently, cognitive behavioural therapy (CBT) is recommended as the first response stand-alone intervention for mild to moderate cases of depressive and anxiety disorders. However, due to the accessibility challenges faced by young people, the integration of technology in a stepped care model with traditional face-to-face therapies such as CBT is receiving increased attention by clinicians in Ireland.

Who can participate?
Young people aged 8-12 who are experiencing low mood and/or anxiety.

What does the study involve?
Participants will be randomly assigned to one of two groups. One group will receive the Pesky gNATs intervention, the other to a waiting list control group. Those taking part in the Pesky gNATs group will play the game with an assistant psychologist for up to 8 weeks. Those allocated to the control group will receive the intervention at a later date.

What are the possible benefits and risks of participating?
Technology-assisted CBT has been shown to be efficacious for children experiencing low mood and anxiety in different settings. In this study, eligible participants could benefit from this evidence-based CBT approach and experience clinically significant positive change. As with any mental health intervention for low mood and anxiety, some participants may have emotionally challenging experiences during the sessions. All researchers and intervention facilitators (assistant psychologists) are vetted, trained in the intervention, and supervised. Moreover, both researchers and intervention facilitators will adhere to: Children First National Guidelines for the Protection and Welfare of Children (Department of Children and Youth Affairs, Ireland); and the Code of Professional Ethics (Psychological Society of Ireland). Due to these factors, this study is considered low-risk.

Where is the study run from?
This study is being run by University College Dublin and takes place in Primary Care Psychology Services within the Health Service Executive (HSE) across Ireland.

When is the study starting and how long is it expected to run for?
This study has commenced in one primary care site (21/09/18), with national extrapolation occurring from 1st February 2019.

Who is funding the study?
This project is funded by a European Union project called TEAM (Technology Enabled Mental Health for Young People). TEAM has received funding from the European Union’s Horizon 2020 research and innovation programme under the Marie Skłodowska-Curie grant agreement No. 722561.

Who is the main contact?
Mr. Darragh McCashin – darragh.mccashin@ucd.ie;
Professor Gary O’Reilly – gary.e.oreilly@ucd.ie
Dr David Coyle – d.coyle@ucd.ie

Trial website

Contact information

Type

Public

Primary contact

Mr Darragh McCashin

ORCID ID

http://orcid.org/0000-0003-2686-2111

Contact details

A14
Insight Centre for Data Analytics
O'Brien Centre for Science
University College Dublin
Belfield.
Dublin
Dublin 4
Ireland
+35317161555
darragh.mccashin@ucd.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Technology-assisted cognitive behavioural therapy – a randomised controlled trial of Pesky gNATs for children

Acronym

Study hypothesis

Is Pesky gNATs an effective intervention for children experiencing low mood or anxiety as delivered by assistant psychologists in a national primary care service?

Ethics approval

Approved 13/11/2018, the Human Research Ethics Committee (HREC) in University College Dublin (UCD Office of Research Ethics, Roebuck Castle, University College Dublin, Belfield, Dublin 4; + 353 1 716 8767; research.ethics@ucd.ie), ref: HS-18-76-McCashin-O’Reilly.
Approved 25/04/2018, the Research Ethics Committee at the University Hospital Limerick (Quality & Safety Department, University Hospital Limerick Dooradoyle Limerick; 061 482519), ref: UL Hospitals Group, 021/18.

Study design

Two-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Low mood and anxiety in children

Intervention

Technology-assisted cognitive behavioural therapy programmes such as Pesky gNATs (O'Reilly & Coyle, 2015) have been demonstrated as feasible tools to include in working with young people, or adults with intellectual disabilities who may be experiencing low mood and/or anxiety (Tunney et al., 2017; Cooney et al., 2017).

This study will examine the effectiveness of Pesky gNATs for children with anxiety and low mood. Using a randomised controlled trial (RCT) design, participants will be randomly assigned to receive the Pesky gNATs intervention or to a waitlist control condition. Those taking part in the Pesky gNATs condition will play the game with an assistant psychologist for up to 8 weeks. Those allocated to the control group will receive the intervention at a later date.

Participants will be randomly assigned to a Pesky gNATs intervention group, or to a waitlist control group. Those taking part in the
Pesky gNATs intervention condition will play the game with an assistant psychologist for up to 8 weeks (Pesky gNATs is a 7-level game, with each level representing one session; but 8 weeks is stated to allow for a screening session). Measures are collected at baseline (pre-intervention Time 1), post-intervention (Time 2), and at a 3-month follow-up (Time 3).

Those allocated to the waitlist control group will receive the intervention at a later date. Measures are collected at baseline (pre-intervention Time 1), 8 weeks after time 1 (Time 2), and at a 3-month follow-up (Time 3).

A random sequence of computer-generated numbers will be applied to the sample by the researcher, and communicated to intervention facilitators. This study will use a simple randomisation approach that can readily be applied to simple block randomisation for smaller samples and extrapolated out to multiple sites where required (Simon, 1999).

Full details on the intervention are openly available at: https://www.peskygnats.com/

Intervention type

Mixed

Phase

Drug names

Primary outcome measure

Levels of low mood and anxiety are measured using the Child Behaviour Checklist (CBCL) Age 6-18 (Achenbach & Rescorla, 2001) – internalising score over a 6-month period.

Secondary outcome measures

1. Externalising psychological difficulty is measured using the Child Behaviour Checklist (CBCL) Age 6-18 (Achenbach & Rescorla, 2001) – remaining scales over a 6 month period.
2. Behavioural competency and behavioural problems are measured using the Youth Self Report (YSR) Age 11-18 (Achenbach & Rescorla, 2001) over a 6-month period.
3. Personal functioning, interpersonal relationships, social relationships and overall sense of wellbeing are measured using the Child Outcome Rating Scale (CORS) (Duncan, Miller and Sparks, 2003) during each level of Pesky gNATs.
4. The young person’s perception of the therapeutic alliance is measured using the Child Session Rating Scale (CSRS) (Duncan, Miller and Sparks, 2003) during each level of Pesky gNATs.
5. Anxiety and depression are measured using the Revised Child Anxiety and Depression Scale (RCADS) (Chorpita et al., 2000) at the beginning (level 1) and end of Pesky gNATs (level 7).

Overall trial start date

01/09/2017

Overall trial end date

29/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 8 to 12 (inclusive).
2. Parent-reported/clinically significant levels of low mood and anxiety – score on CBCL in the clinical range on the internalising scale.

Participant type

Mixed

Age group

Child

Gender

Both

Target number of participants

Using Cohen (1992) power calculations, 64 participants will be targeted for each group to detect a medium effect using ANOVA analysis with 2 groups (α = .05; power = .80).

Participant exclusion criteria

1. Formal diagnosis of intellectual disability.
2. Other interpersonal difficulties that could adversely impact participation: active psychosis, significant cognitive difficulties, and English language difficulties.

Recruitment start date

21/04/2018

Recruitment end date

29/02/2020

Locations

Countries of recruitment

Ireland

Trial participating centre

Health Service Executive (HSE) Ireland - Primary Care Psychology Services
Dr. Steevens' Hospital
Dublin
Dublin 8
Ireland

Sponsor information

Organisation

University College Dublin

Sponsor details

School of Psychology
University College Dublin
Belfield
Dublin
Dublin 4
Ireland
+353 1 716 7777
team@ucd.ie

Sponsor type

University/education

Website

https://www.ucd.ie/psychology/

Funders

Funder type

Government

Funder name

Horizon 2020

Alternative name(s)

European Union Framework Programme for Research and Innovation, EU Framework Programme for Research and Innovation, Horizon 2020 - Research and Innovation Framework Programme

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Results and Publications

Publication and dissemination plan

This RCT will be published open access. We intend to publish the quantitative and qualitative results separately, with the view to openly accessible papers in 2020-2021.

IPD sharing statement: the datasets generated during and/or analysed during the current study are not expected to be made available due to this research involving sensitive data regarding minors in primary care services who are experiencing clinically significant levels of psychological difficulties.

Intention to publish date

29/05/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/04/2019: Internal review. 29/03/2019: Trial's existence confirmed by the Human Research Ethics Committee (HREC) in University College Dublin.