A placebo controlled pilot study to explore the affects of GABA tea on children with autistic spectrum conditions

Not Applicable

Completed

• Conditions: Autism Spectrum Conditions; Mental and Behavioural Disorders

• Registration Number: ISRCTN72571312
• Lead Sponsor: Coventry University

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31060476 (added 08/05/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-09-01
• Study Start: 2017-11-21
• Last Update Posted: 27 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Diagnosis of ASC
2. No known co-occurring ADHD, genetic or medical conditions
3. No current medication
4. A willingness to drink tea
5. The ability to wear a watch without tactile sensitivity
6. Younger than 14 (due to a large increase in testosterone levels after this point (Mayo Foundation for Medical Education and Research website, 1995-2017))
7. Both parent and child commitment to four university visits and precise tea making and drinking requirements

Exclusion Criteria

1. No diagnosis of ASC
2. Known co-occurring ADHD
3. Genetic or medical conditions
4. Current medication
5. An unwillingness to drink tea
6. Difficulty in wearing a watch due to tactile sensitivity
7. Older than 14 (due to a large increase in testosterone levels after this point (Mayo Foundation for Medical Education and Research website, 1995-2017))
8. Both parent and child uncommited to four university visits and precise tea making and drinking requirements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Autism severity (including social communication, unusual behaviours, anxiety and rigidity) are measured using the ASRS (6-18 Years, Parent form) at the end of the second week of each tea condition

Secondary Outcome Measures

Name	Time	Method
<br> 1. Sensory responsivity is measured using Sensory Profile 2 at the end of the second week of each tea condition<br> 2. Coordination (manual dexterity, aiming and catching and balance) is measured using The Movement Assessment Battery for Children at the end of the second week of each tea condition<br> 3. Sleep quality, duration and timing measured using Actigraphy sleep monitoring for the duration of the last week of each tea condition<br> 4. Melatonin and cortisol levels are measured using hormone assaying at the end of the second week of each tea condition using saliva samples form the last afternoon, evening and following morning<br>