Experimental Evaluation of the Fear-less Triple P Workshop

Last registered on November 05, 2018
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Pre-Trial

Trial Information

General Information

Title
Experimental Evaluation of the Fear-less Triple P Workshop
RCT ID
AEARCTR-0003530
Initial registration date
November 05, 2018

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
November 05, 2018, 8:12 PM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country
Ireland
Region
Midlands Area

Primary Investigator

Name
Merin Joseph
Affiliation
University College Dublin
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Other Primary Investigator(s)

PI Name
Apurva Chikhale
PI Affiliation
University College Dublin
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PI Name
Kun Wu
PI Affiliation
University College Dublin
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PI Name
Sheenam Wadhwa
PI Affiliation
University College Dublin
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PI Name
Colm Mulcahy
PI Affiliation
University College Dublin
Contact Investigator
PI Name
Aisling Burns
PI Affiliation
University College Dublin
Contact Investigator
PI Name
Jordan Shelby Eng
PI Affiliation
University College Dublin
Contact Investigator

Additional Trial Information

Status
On going
Start date
2018-11-01
End date
2019-07-31
Keywords
Health
Additional Keywords
Anxiety in children
JEL code(s)
Secondary IDs
Abstract
This project aims to evaluate the effectiveness of a specific type of parenting intervention in an Irish context. We will run a randomised control trial (RCT) of the Fear-less Workshop to be delivered by our implementation partner, the Midlands Area Parenting Partnership (MAPP), called “Fear-less Triple P”, which targets parents of 6 to 14-year old’s.

Fear-less Triple P is a 6-hour small group intervention, which is run over 2 non-consecutive days for 3hrs each day. The intervention aims to educate parents about anxiety in children and the principles of a cognitive-behavioural approach to anxiety management. Each of the two 3hr sessions is facilitated by a trained and accredited Triple P practitioner. The research team will not be involved in delivering the intervention. Only MAPP practitioners, who come from a range of professions and have a recommended minimum QCF-4/5 level qualifications, will be involved in delivering the intervention. This discussion group focuses on the topic “parenting an anxious child”. The programme has four main goals. The first goal is to help parents provide their children with the best possible model of anxiety management. The second goal is to help parents so that they can help their children become more resilient. The third goal is to work with parents in developing a plan for helping the children manage anxiety more effectively and become flexible thinkers. The final goal focuses on how parents react to their anxious child and provide strategies to deal with this.

The parents will receive a workbook at the start of the workshop which includes the content to be covered in the sessions, as well as practical exercises which will be conducted during the sessions. The workbook aims to reinforce the material presented, in addition to being used by parents at home after the sessions have ended.

Trained facilitators from MAPP, which is a collaboration of 18 organisations from the public, community and voluntary sector in Longford, Westmeath, Laois and Offaly, will deliver the intervention.

Currently there has been one proof-of-concept RCT of the 6-week Group Fear-less intervention, however, the efficacy of the brief Fear-less Workshop has yet to be tested. Our assignment aims to conduct the first RCT of the Fear-less Workshop.
External Link(s)

Registration Citation

Citation
Burns, Aisling et al. 2018. "Experimental Evaluation of the Fear-less Triple P Workshop." AEA RCT Registry. November 05. https://doi.org/10.1257/rct.3530-1.0
Former Citation
Burns, Aisling et al. 2018. "Experimental Evaluation of the Fear-less Triple P Workshop." AEA RCT Registry. November 05. https://www.socialscienceregistry.org/trials/3530/history/36805
Sponsors & Partners

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Experimental Details

Interventions

Intervention(s)
The intervention will be delivered by MAPP and evaluated using a randomised controlled trial with a waitlist condition. Treated participants will receive the intervention during the study while the control group will be assigned to receive the intervention on a later date (approximately one month later).
Intervention Start Date
2018-11-01
Intervention End Date
2019-07-31

Primary Outcomes

Primary Outcomes (end points)
We are interested in finding out the change in the behaviour of parents of children suffering from clinical anxiety after attending the workshop organized by professionals from MAPP.
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Our secondary outcome is the change in the anxiety of children according to Spens Scale.
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Parents who attended three public seminars on the Fear-less intervention provided by MAPP in October 2018 will form the target population. These seminars were brief 1.5hr seminars held in 3 different locations in the Midlands. All parents who have concerns about childhood anxiety were invited by MAPP to attend. During the seminars, parents completed a short questionnaire (administrated and analysed by MAPP) which included the Spence Child Anxiety Questionnaire, Short Form. At the end of the questionnaire, parents ticked an opt in box and provided a phone number if they wished to be contacted by MAPP again to participate in further Fear-less sessions and research. For parents whose children scored above 7 (i.e. within the clinical range) on the Spence scale AND consented to be contacted again, MAPP will contact those parents and invite them to participate in the Fear-less workshop. MAPP will send the participants an email which includes a link to the Information Sheet and Consent Form for this study. If parents’ consent to join the study, they will complete the baseline questionnaire and be assigned to the treatment or waitlist condition. The surveys will be conducted using Lime Survey portal. Note that the research team will not have access to the participants’ names or email addresses, they will only see their ID number. The baseline data will include basic demographics questionnaire and the Spence Scale for Anxiety Long Form, Depression Anxiety Stress Scales short form, and the Parenting an Anxious Child Scale. The Spence Scale for Anxiety is free for research purposes. The Depression Anxiety Stress Scales short form is in the public domain and the Parenting an Anxious Child Scale is free to use, as well. Participants will then be randomised through simple individual randomisation and assigned to the treatment or waitlisted date. The time and date of their Fear-less session will appear on the final screen. The research team will then send MAPP a list of the ID numbers which indicates which condition the parents have been assigned. The treatment will then be delivered by the implementation partner, MAPP. After the treatment is completed, MAPP will send the parents a link to the endline survey (same questionnaire yet excluding the demographic questions, with a satisfaction survey for treated participants included). The control group will receive the intervention one month later. The treatment group will also be asked to complete a follow-up questionnaire 6 months after the treatment has been delivered using the same outcome variables.

Data analysis will include significance testing on differences between crucial outcome measures in both the Spence scale and the Parenting an Anxious Child scale for both groups. A regression will be conducted to evaluate any significant relationship between parenting behaviours and the child’s anxiety.
Experimental Design Details
Randomization Method
The randomisation is done by Lime Survey, the portal which we are using to collect our baseline and endline data.
Randomization Unit
Individual level of randomisation will be done.
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
We are not using clusters for our experiment. We plan to include 120 parents in our experiment.
Sample size: planned number of observations
120 parents.
Sample size (or number of clusters) by treatment arms
60 parents control and 60 parents treatment
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
Supporting Documents and Materials
IRB

Institutional Review Boards (IRBs)

IRB Name
Human Research Ethics Committee - Economics
IRB Approval Date
2018-10-31
IRB Approval Number
Econ001
Analysis Plan

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials