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Lightning Process to be Evaluated in Research Study on Children

Dx Revision Watch

Suzy Chapman Owner of Dx Revision Watch
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3,061
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UK
LP for Hayfever

http://www.lightningprocess.com/Default.aspx?tabid=480&language=en-US

"Getting free from Hayfever

Many people have reported how much their hayfever has been relieved by the Lightning Process.

Phil Parker has created a specially designed audio programme to help you eliminate hayfever, you can download it for free using the link below.

Eliminating hayfever

http://www.lightningprocess.com/Portals/1/podcast/hayfever 3.mp3

Latest version of the free audio program to eliminate your hayfever this summer, from Phil Parker, the designer of The Lightning Process. Download

If you would like to make an optional donation to the charity Water Aid then please click here"
 

Mithriel

Senior Member
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690
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Scotland
It is also important to know if there are significant side effects."

So they are doing the study to see if there are significant side effects. This will be significant side effects in children.... So if the children are left bed ridden and tube fed for the rest of a short miserable life, at least we will have answered some questions.

We really need a brick wall or an I despair smiley.

Mithriel
 

Dx Revision Watch

Suzy Chapman Owner of Dx Revision Watch
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3,061
Location
UK
So they are doing the study to see if there are significant side effects...

I know, Mithriel, it is shocking. Once again, I cannot understand how this pilot (or for that matter, any full RCT that might result out of it, would get ethics approval - assuming it has already obtained ethics approval - and this has not been established yet), when no RCTs have been undertaken into the safety and efficacy of the application of LP in adults with CFS and ME.

In the meantime, the ME Association and The Young ME Sufferers Trust remain silent on their positions. I shall be sending a copy of the FOI to Jane Colby tomorrow.

Suzy
 

Angela Kennedy

Senior Member
Messages
1,026
Location
Essex, UK
I know, Mithriel, it is shocking. Once again, I cannot understand how this pilot (or for that matter, any full RCT that might result out of it, would get ethics approval - assuming it has already obtained ethics approval - and this has not been established yet), when no RCTs have been undertaken into the safety and efficacy of the application of LP in adults with CFS and ME.

In the meantime, the ME Association and The Young ME Sufferers Trust remain silent on their positions. I shall be sending a copy of the FOI to Jane Colby tomorrow.

Suzy

On top of this also, though, is the general problem of weird, problematic and likely dangerous 'treatments' being given RCT's in the first place. To be honest, if one thinks about say, Graded Exercise and/or CBT in 'CFS', there are OBVIOUS risks to at least certain people if one takes into account the evidence base already available, let alone the poor methodology that makes a mockery of the idea that RCT's are a 'gold standard' test, yet, money is still being allocated to these trials.

By the use of subjective reports and encouraging the children to become deferent, stoic or optimistic, or even less ethical ways of producing positive self or parent report responses in an RCT, LP could quite easily be claimed to be efficacious, whether done on adults or children. Even if this trial was post-poned until after a trial had been done on adults- the above problems remain.
 

Mithriel

Senior Member
Messages
690
Location
Scotland
I took ill when I was fourteen and though I never missed any school I often felt ill and had a lot of pain and funny symptoms.

I had very good parents, but I tried to hide what I was feeling as much as possible. If I complained I would get whisked off to the doctor where I couldn't explain what was wrong and it never did much good. My mum would get annoyed and I would feel guilty. Since it was a long walk to the doctor's which made me feel worse as well I took to not complaining. My mum and dad were happy because they thought I was feeling better and life was more pleasant.

So my coping strategy was to deny how I was feeling and to ignore as many symptoms as I could.

We also lived in a culture where it was frowned upon to "give in" to illness and where you had to keep busy all the time. I would be helping them weed the garden then have to crawl up the stairs to the toilet as long as no one was watching.

It was the same at school, much easier to ignore how I felt than to deal with the consequences. Teenagers don't suddenly lose the power of speech or go blind so I knew I would not be believed. I knew much better than to try to explain so I ended up lying and giving a sullen nod of the head or making some more believable excuse.

It got to the point where I would get my key in the lock. open the door and collapse onto the floor as I couldn't keep up the pretence any more. I am sure that I am as bad as I am today because of all that. I managed to hide how bad I was from everyone except my husband for years.

Children will easily believe that they aren't actually ill and that they just have bad behaviour. Everyone will be pleased with them, they will feel happy about that and get a big reward.

Their bodies may even take the strain for a few years.

It is wicked.

Mithriel
 

Dolphin

Senior Member
Messages
17,567
On top of this also, though, is the general problem of weird, problematic and likely dangerous 'treatments' being given RCT's in the first place. To be honest, if one thinks about say, Graded Exercise and/or CBT in 'CFS', there are OBVIOUS risks to at least certain people if one takes into account the evidence base already available, let alone the poor methodology that makes a mockery of the idea that RCT's are a 'gold standard' test, yet, money is still being allocated to these trials.

By the use of subjective reports and encouraging the children to become deferent, stoic or optimistic, or even less ethical ways of producing positive self or parent report responses in an RCT, LP could quite easily be claimed to be efficacious, whether done on adults or children. Even if this trial was post-poned until after a trial had been done on adults- the above problems remain.
Good points.
 

Dx Revision Watch

Suzy Chapman Owner of Dx Revision Watch
Messages
3,061
Location
UK
...By the use of subjective reports and encouraging the children to become deferent, stoic or optimistic, or even less ethical ways of producing positive self or parent report responses in an RCT, LP could quite easily be claimed to be efficacious, whether done on adults or children. Even if this trial was post-poned until after a trial had been done on adults- the above problems remain.

I don't consider that it would be ethical to trial LP on either adults or children.

But the immediate issue is that a pilot has been proposed for a vulnerable patient group when no rigorous RCTs in the application of LP have been carried out in adults which is a basis for challenging a decision to grant ethics approval.
 

jace

Off the fence
Messages
856
Location
England
Mithriel, thank you for telling your story ***hugs*** It is people having the courage to tell it how it is that has given me the information that I needed to avoid continuing on the down-hill slide, and begin to stabilise and even repair some of the damage ME has caused in my body.

Suzie, thank you for all your brilliant work - I really hope you win on this one.
FWIW the Lindbury Trust http://www.linburytrust.org.uk/ gave just under 108,000, as detailed in their annual report for 2009 http://www.linburytrust.org.uk/pdfs/Linbury Trust Annual Report 09.pdf
 

Angela Kennedy

Senior Member
Messages
1,026
Location
Essex, UK
I don't consider that it would be ethical to trial LP on either adults or children.

But the immediate issue is that a pilot has been proposed for a vulnerable patient group when no rigorous RCTs in the application of LP have been carried out in adults which is a basis for challenging a decision to grant ethics approval.

Hi Suzy

Oh yes - I totally agree it's a good basis to challenge this current one. You have my full support on this whole project. I'm just thinking ahead and around a bit.

I do think long term we need to find effective ways of publically demonstrating how unethical these treatments are (and that includes CBT and GET), and how they do NOT lend themselves to rigourous gold standard research etc.

Currently, taking the situation to its logical extreme, if stalwarts like Crawley, Findley, Wessely White and Sharpe, Chalder, Deary Tom Cobley and all hypothetically decided to do 'RCTs' on faith healing for 'CFS', or epidemiological studies showing statistical correlation between star sign and incidence of 'CFS' (one star sign is always likely to come out more than another) and these were published, these studies would, technically, have to be included as 'evidence based medicine'.

This may sound stupid. However, the belief in an extant but occult 'psychosomatic' process that causes severe impairment but can be willed away by positive thinking - even if by lying to one's self, is pretty 'wooey'.

LP appears to be riding on the coat tails of CBT- which itself pretty 'wooey' and unscientific, but, because CBT has been subject to (flawed) 'RCT's - and thus claimed as 'scientific' it is given a free ride by, for example, NICE, or those over on BS.

If people are not successful in stopping the Crawley LP trial, it won't be just those poor children adversely affected. But even if it's stopped this time - they'll be looking to try again in the future. In the meantime - they'll also be wanting to try CBT/GET on children, of which the similarities with LP are pretty striking.
 

willow

Senior Member
Messages
240
Location
East Midlands
This really troubles me too. I'm almost choking incredulity and fear for these children. Compleltely unhelpful I know.

I've said before that like Mithriel I was ill as a child. My parents were and still are good people but had and still have difficulty in accepting my ilnness and some others too. After a while I took the route of least pain which was to bury my ill health... as far as possible.

In desperation and believing it was my fault asged18 I tried to join a gym to get fit. There was an exercise bike test before joining which the owner stopped, told me my heart was worse than that of a heavy smoking 40 year old who had never, ever exercised and that I was to go straight to my GP and demand a cardiac referral. I got the referal but you can guess the outcome.

Thanks for your work with this Suzy.
 

Dx Revision Watch

Suzy Chapman Owner of Dx Revision Watch
Messages
3,061
Location
UK
...If people are not successful in stopping the Crawley LP trial, it won't be just those poor children adversely affected. But even if it's stopped this time - they'll be looking to try again in the future. In the meantime - they'll also be wanting to try CBT/GET on children, of which the similarities with LP are pretty striking.

They already do use CBT in children at KCL. Chalder led that pilot CBT trial, published in 2002 (you remember when Vincent Deary, then with KCL, snuck onto the charities forum MEssage-UK the weekend the article about the pilot study was published?).

AYME on CBT:

http://www.ayme.org.uk/article.php?sid=10&id=209
 

Dx Revision Watch

Suzy Chapman Owner of Dx Revision Watch
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3,061
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UK
http://www.ncbi.nlm.nih.gov/pubmed/19422732

Br J Health Psychol. 2010 Feb;15(Pt 1):167-83. Epub 2009 May 6.

Cognitive behavioural therapy and psycho-education for chronic fatigue syndrome in young people: reflections from the families' perspective.
Dennison L, Stanbrook R, Moss-Morris R, Yardley L, Chalder T.

Centre for Clinical Applications of Health Psychology, University of Southampton, UK.

Abstract
OBJECTIVES: Recent trials have produced optimistic results for family-focussed cognitive behavioural therapy (CBT) for chronic fatigue syndrome (CFS) in young people. This study sought to examine the under-researched question of the views and experiences of patients and families who take part. DESIGN: Semi-structured interviews and qualitative analysis were chosen in order to address clients' perspectives in depth. METHODS: Sixteen young people and sixteen parents who participated in a trial of CBT versus psycho-education (PE) for CFS were interviewed. Key themes were discerned using inductive thematic analysis. RESULTS: Most families had low expectations of a cure but hope for improvement. Generally speaking, participants found both CBT and PE acceptable and helpful. Behavioural aspects of CBT (e.g. goal-setting, graded activity) were found helpful. The opportunity to gain support, recognition and validation was important. Cognitive elements of therapy were sometimes deemed inappropriate and some felt emotional aspects of CFS were not adequately addressed. Participants were ambivalent towards the extent of family involvement. Negative experiences related to the therapy setting and feeling inappropriately labeled. Most participants felt therapy was a stepping-stone towards normal life, although many felt recovery was incomplete. Very few differences were found between themes from CBT and PE participants. A notable exception was that every young person who experienced CBT described therapy as helpful, whereas the participants who strongly opposed the therapy approach had all experienced PE. CONCLUSIONS: The detailed insights regarding families' therapy experiences suggest areas of improvement for service delivery and topics for further investigation.

PMID: 19422732 [PubMed - indexed for MEDLINE]

-----------------

http://www.ncbi.nlm.nih.gov/pubmed/19891804

Psychol Med. 2009 Nov 6:1-11. [Epub ahead of print]

Family-focused cognitive behaviour therapy versus psycho-education for chronic fatigue syndrome in 11- to 18-year-olds: a randomized controlled treatment trial.
Chalder T, Deary V, Husain K, Walwyn R.

Department of Psychological Medicine and Psychiatry, King's College London, Weston Education Centre, London, UK.

Abstract
BACKGROUND:
Only one previous randomized controlled trial (RCT) has examined the efficacy of cognitive behaviour therapy (CBT) for chronic fatigue syndrome (CFS) in children. The aim of this study was to compare family-focused CBT with psycho-education for CFS in adolescents.MethodSixty-three 11- to 18-year-olds (43 girls, 20 boys) with CFS were randomly assigned to either family-focused CBT or psycho-education delivered over 6 months. School attendance was the main outcome, which was assessed at the end of treatment and at 3, 6 and 12 months follow-up. RESULTS: At the main outcome point (the 6-month follow-up) both groups had improved similarly. However, although those who received family-focused CBT were attending school for longer than those who received psycho-education, at discharge from treatment and at 3 months follow-up, they improved less quickly across the follow-up period. CONCLUSIONS: Adolescents with CFS get back to school more quickly after family-focused CBT. This is important as they are at a crucial stage of their development. However, the finding that psycho-education was as effective as family-focused CBT at 6 and 12 months follow-up has important implications for health service delivery.

PMID: 19891804 [PubMed - as supplied by publisher]

----------------

http://www.ncbi.nlm.nih.gov/pubmed/11827901

Arch Dis Child. 2002 Feb;86(2):95-7.

Family cognitive behaviour therapy for chronic fatigue syndrome: an uncontrolled study.
Chalder T, Tong J, Deary V.

Academic Department of Psychological Medicine, Guy's, King's and St Thomas' School of Medicine, 103 Denmark Hill, London SE5 8AZ, UK. t.chalder@iop.kcl.ac.uk

Abstract
AIM: To examine the efficacy of family focused cognitive behaviour therapy for 11-18 year olds with chronic fatigue syndrome. METHODS: Twenty three patients were offered family focused cognitive behaviour therapy. The main outcome was a fatigue score of less than 4 and attendance at school 75% of the time. RESULTS: Twenty patients completed treatment. Eighteen had completed all measures at six months follow up; 15 of these (83%) improved according to our predetermined criterion. Substantial improvements in social adjustment, depression, and fear were noted. CONCLUSIONS: Family focused cognitive behaviour therapy was effective in improving functioning and reducing fatigue in 11-18 year olds. Gains were maintained at six months follow up.

PMID: 11827901 [PubMed - indexed for MEDLINE]PMCID: PMC1761081Free PMC Article

Free full text here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1761081/?tool=pubmed

Free PDF here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1761081/pdf/v086p00095.pdf
 

Angela Kennedy

Senior Member
Messages
1,026
Location
Essex, UK
http://www.ncbi.nlm.nih.gov/pubmed/19422732

Br J Health Psychol. 2010 Feb;15(Pt 1):167-83. Epub 2009 May 6.

Cognitive behavioural therapy and psycho-education for chronic fatigue syndrome in young people: reflections from the families' perspective.
Dennison L, Stanbrook R, Moss-Morris R, Yardley L, Chalder T.

Centre for Clinical Applications of Health Psychology, University of Southampton, UK.

Abstract
OBJECTIVES: Recent trials have produced optimistic results for family-focussed cognitive behavioural therapy (CBT) for chronic fatigue syndrome (CFS) in young people. This study sought to examine the under-researched question of the views and experiences of patients and families who take part. DESIGN: Semi-structured interviews and qualitative analysis were chosen in order to address clients' perspectives in depth. METHODS: Sixteen young people and sixteen parents who participated in a trial of CBT versus psycho-education (PE) for CFS were interviewed. Key themes were discerned using inductive thematic analysis. RESULTS: Most families had low expectations of a cure but hope for improvement. Generally speaking, participants found both CBT and PE acceptable and helpful. Behavioural aspects of CBT (e.g. goal-setting, graded activity) were found helpful. The opportunity to gain support, recognition and validation was important. Cognitive elements of therapy were sometimes deemed inappropriate and some felt emotional aspects of CFS were not adequately addressed. Participants were ambivalent towards the extent of family involvement. Negative experiences related to the therapy setting and feeling inappropriately labeled. Most participants felt therapy was a stepping-stone towards normal life, although many felt recovery was incomplete. Very few differences were found between themes from CBT and PE participants. A notable exception was that every young person who experienced CBT described therapy as helpful, whereas the participants who strongly opposed the therapy approach had all experienced PE. CONCLUSIONS: The detailed insights regarding families' therapy experiences suggest areas of improvement for service delivery and topics for further investigation.

PMID: 19422732 [PubMed - indexed for MEDLINE]

-----------------

http://www.ncbi.nlm.nih.gov/pubmed/19891804

Psychol Med. 2009 Nov 6:1-11. [Epub ahead of print]

Family-focused cognitive behaviour therapy versus psycho-education for chronic fatigue syndrome in 11- to 18-year-olds: a randomized controlled treatment trial.
Chalder T, Deary V, Husain K, Walwyn R.

Department of Psychological Medicine and Psychiatry, King's College London, Weston Education Centre, London, UK.

Abstract
BACKGROUND:
Only one previous randomized controlled trial (RCT) has examined the efficacy of cognitive behaviour therapy (CBT) for chronic fatigue syndrome (CFS) in children. The aim of this study was to compare family-focused CBT with psycho-education for CFS in adolescents.MethodSixty-three 11- to 18-year-olds (43 girls, 20 boys) with CFS were randomly assigned to either family-focused CBT or psycho-education delivered over 6 months. School attendance was the main outcome, which was assessed at the end of treatment and at 3, 6 and 12 months follow-up. RESULTS: At the main outcome point (the 6-month follow-up) both groups had improved similarly. However, although those who received family-focused CBT were attending school for longer than those who received psycho-education, at discharge from treatment and at 3 months follow-up, they improved less quickly across the follow-up period. CONCLUSIONS: Adolescents with CFS get back to school more quickly after family-focused CBT. This is important as they are at a crucial stage of their development. However, the finding that psycho-education was as effective as family-focused CBT at 6 and 12 months follow-up has important implications for health service delivery.

PMID: 19891804 [PubMed - as supplied by publisher]

----------------

http://www.ncbi.nlm.nih.gov/pubmed/11827901

Arch Dis Child. 2002 Feb;86(2):95-7.

Family cognitive behaviour therapy for chronic fatigue syndrome: an uncontrolled study.
Chalder T, Tong J, Deary V.

Academic Department of Psychological Medicine, Guy's, King's and St Thomas' School of Medicine, 103 Denmark Hill, London SE5 8AZ, UK. t.chalder@iop.kcl.ac.uk

Abstract
AIM: To examine the efficacy of family focused cognitive behaviour therapy for 11-18 year olds with chronic fatigue syndrome. METHODS: Twenty three patients were offered family focused cognitive behaviour therapy. The main outcome was a fatigue score of less than 4 and attendance at school 75% of the time. RESULTS: Twenty patients completed treatment. Eighteen had completed all measures at six months follow up; 15 of these (83%) improved according to our predetermined criterion. Substantial improvements in social adjustment, depression, and fear were noted. CONCLUSIONS: Family focused cognitive behaviour therapy was effective in improving functioning and reducing fatigue in 11-18 year olds. Gains were maintained at six months follow up.

PMID: 11827901 [PubMed - indexed for MEDLINE]PMCID: PMC1761081Free PMC Article

Free full text here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1761081/?tool=pubmed

Free PDF here: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1761081/pdf/v086p00095.pdf

Oh god, I'd forgotten about this - though of course I was aware of certain Dutch studies (I meant MORE cbt/get research on children etc.)

All the same old massive flaws in methodology (cohort criteria, outcome measurements, etc. etc.), weak 'positive' outcomes AT BEST, given the mantle of respectable scientific findings, soon, no doubt, coming to official guidelines for ME/CFS diagnosed children.
 

Mithriel

Senior Member
Messages
690
Location
Scotland
I would be more impressed by an outcome measure of activities done as well as school attendance. School attendance is used as an indirect measure of health but it can be imposed on a child. How much socialising they chose to do outwith school is a better indication of how well they are feeling.

I can't understand this obsession with school attendance. We want our children to be educated and we want them to socialise. Physically going to a school is not the only way to develop these skills. They have bad points as well. A vulnerable child does not need the added problems of bullying or pressure to conform.

The only way school attendance should be scored is full time for a term. If a child is better they will go full time, if they are not their attendance will be patchy. Differences in patchiness is meaningless. I had six asthma attacks last week but only five this week so I am cured....

Though we know the whole thing is rubbish.

Mithriel
 

willow

Senior Member
Messages
240
Location
East Midlands
I would be more impressed by an outcome measure of activities done as well as school attendance.

Is it not possible to come up with other measurements such as neuropsych testing as they use for people with brain injury (I've taken these) and physical tests to do with balance, pulse rate after certain tasks, muscle strength, reflex response etc? Of course it would have to be sensitively carried out so as not to injure the child and also be valid indicators... And maybe that's asking too much.

I would say the focus on school attendance is not about educational or social concerns but about compliance.
 

Mithriel

Senior Member
Messages
690
Location
Scotland
Yes, you give them a treatment where they have to do what they are told no matter how many symptoms they feel and then when they do it you say that is proof they no longer feel the symptoms.

Mithriel
 

Dx Revision Watch

Suzy Chapman Owner of Dx Revision Watch
Messages
3,061
Location
UK
I would be more impressed by an outcome measure of activities done as well as school attendance. School attendance is used as an indirect measure of health but it can be imposed on a child. How much socialising they chose to do outwith school is a better indication of how well they are feeling.

I can't understand this obsession with school attendance. We want our children to be educated and we want them to socialise. Physically going to a school is not the only way to develop these skills. They have bad points as well. A vulnerable child does not need the added problems of bullying or pressure to conform.

The only way school attendance should be scored is full time for a term. If a child is better they will go full time, if they are not their attendance will be patchy. Differences in patchiness is meaningless. I had six asthma attacks last week but only five this week so I am cured....

Though we know the whole thing is rubbish.

Mithriel

I understand exactly what you mean, Mithriel. It's as though full-time mainstream school attendance and the ability to gain a minimum of 5 good GSCEs is how our children's worth and wellbeing is measured. I'm pleased for the young people concerned, but when I read media articles featuring "young person with ME who still managed to gain 5 A and B grades" or whatever, it serves to reinforce this idea that our children are not valued for themselves but the extent to which they conform to society's expectations of mainstream educational aspirations.

Families of home educated children have come under particular scrutiny when a child or young person has, or is suspected of having ME even though the family has the right to home educate and the child has the right to continue to be home educated during periods of illhealth or longterm illness.

I included the following in the FOI to Bristol:

j) The press release published on 02 March 2010 states that the primary outcome measure will be "school attendance after six-months".

What other outcome measures will be recorded?

Other than school attendance after six months, are other outcome measures being recorded such as the child or young person's ability to complete comparable amounts of homework assignments as their peer group, ability to participate in normal family/social activities outside school hours, resume hobbies, sporting activities, requirement for rest/sleep outside school hours etc?

k) Will monitoring of participants' school attendance and level of functioning be undertaken beyond the six month point? Please specify at what intervals.

l) Prior to recruitment to the study or following recruitment, will prospective participants undergo any assessment of fitness/physical functioning or other physiological assessment, or psychological assessment? Please specify which assessment tools will be used.

Will participants be re-assessed following the study and will these assessments be recorded as outcome measures?
 

Dx Revision Watch

Suzy Chapman Owner of Dx Revision Watch
Messages
3,061
Location
UK
...Suzie, thank you for all your brilliant work - I really hope you win on this one.

Wading through treacle at the moment.

FWIW the Lindbury Trust http://www.linburytrust.org.uk/ gave just under 108,000, as detailed in their annual report for 2009 http://www.linburytrust.org.uk/pdfs/Linbury Trust Annual Report 09.pdf

Thanks for this, Jace, but it may be the case that this was not awarded for the LP trial as Dr Crawley and her team have been awarded a number of grants in the last couple of years for various CFS/ME studies and it is from the 2008/2009 Annual Report and Accounts. Year end April 2009 sounds a bit too early for this LP pilot study.

"University of Bristol
Towards research project into paediatric issues in CFS / ME"

Suzy
 

Dolphin

Senior Member
Messages
17,567
Is it not possible to come up with other measurements such as neuropsych testing as they use for people with brain injury (I've taken these) and physical tests to do with balance, pulse rate after certain tasks, muscle strength, reflex response etc? Of course it would have to be sensitively carried out so as not to injure the child and also be valid indicators... And maybe that's asking too much.

I would say the focus on school attendance is not about educational or social concerns but about compliance.
Those outcome measures would be good.

A cheap one, which might not be perfect, is a pedometer. Studies suggest that CBT doesn’t lead to (statistically significant) increases activity over the control group (one of the three studies was on children! http://www.bmj.com/cgi/content/full/330/7481/14?view=long&pmid=15585538).