I shall have further comment to add, later. But firstly, a misconception on the part of Dr Frivold needs addressing:
"I applaud the British National Health Service for granting funds for a randomized controlled study in children."
Funding for the pilot study in children is
not being provided by the NHS. Funding has been awarded externally by the Linbury Trust and the Ashden Trust.
"I would also love to see objective, randomized, controlled studies of adults using the LP."
No study should be undertaken involving children (a vulnerable patient group) until rigorous controlled trials have first been undertaken in adults.
Dr Frivold may wish to familiarise himself with MRC research ethics guidelines for research involving children.
"MRC Medical Research Involving Children (Nov 2004, revised Aug 2007)" and in particular, sections 4.1 and 4.3 which he can access here:
http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430
Whether the pilot study has received research ethics approval is in the process of being established.
A Freedom of Information request has been raised in relation to this proposed pilot study a copy of which can be accessed here:
http://tinyurl.com/FOIrequestLP1
Questions raised include:
a) No rigorous controlled trials have been published on the application of the Lightning Process in adults. What data has been used in order to establish that overall the likely benefits of the research outweigh any risks to the participants?
With reference to the document "MRC Medical Research Involving Children (Nov 2004, revised Aug 2007)" sections 4.1 and 4.3, what is the rationale for undertaking a pilot study in children when rigorous controlled trials have yet to be undertaken and results published on the application of Lightning Process in adults?
[...]
d) Will children or their parents/guardians be expected to sign up in agreement with certain beliefs and commitments in order to demonstrate the child's "readiness" to undertake the program?
If so, what beliefs and commitments will they be expected to sign up to and at what point in the recruitment process would agreement with beliefs and commitments be sought?
For the purposes of the study, how will "readiness" be defined, by whom, and what tools will be used to assess or determine a child's "readiness"?
e) If selection for and participation in the study does not involve the signing up in agreement with certain beliefs and commitments, either by the child or by their parents / guardians on their behalf, through what means are children to be assessed for suitability for and potential to benefit from the application of the Lightning Process?
f) By what means will it be determined that undergoing the training program would not be detrimental to a child's current health status, as a patient diagnosed with CFS/ME?
What safeguards will be put in place to avoid the potential for exacerbation of existing symptoms or the development of new symptoms whilst undertaking the sessions, in-between sessions and in the weeks and months following completion of the program?
What support will be given to children and their families if a child were to experience exacerbation of existing symptoms or develop new symptoms as a result of participating in the program or as a result of practicing the instructions in-between sessions or in the weeks and months following completion of the program?
g) It is understood that the Lightning Process is being marketed by some franchised "instructors/trainers/coaches" as a process that should be effective for all participants in resolving their symptoms if
a) they are "ready" to undertake the process and
b) they carry out the instructions properly.
This might be considered to place a considerable burden of responsibility on a vulnerable research group and their families in terms of compliance and outcome.
What consideration has been given to the issue of power imbalances where participants (or their families) may feel obliged to please or comply with the researcher's requests or with "instructor/trainer/coach" requests while the program is being delivered, and beyond, throughout the life of the project?
By what means will it be determined that undergoing the "process" will not be detrimental to the child's psychological well-being or impact negatively on the family dynamic if the child failed to gain benefit from the program, or if the child were to experience set-back or significant relapse during or following the program, or if apparent improvement or resolution of symptoms/disability following the program were short-lived?
What safeguards will be put in place in order to protect the child's psychological well-being?
Suzy Chapman
http://meagenda.wordpress.com