yourattentionplease

Grow with confidence

Grow With Confidence The method, tested in a clinical trial

Detail of the clinical trial


The method was tested with 156 children diagnosed with ADHD

 

The University of Vienna coordinated the study, which was conducted at a primary school in Madrid, Spain, and showed that the method Grow with Confidence improved sustained attention and reduced anxiety in 156 children between seven and twelve years old who were diagnosed with ADHD.

Design of the study: Groups A and B

Study sample: 156 children,  7 to 12 years old, with ADHD diagnosis from groups A and B. 

The anxiety tests (STAIC and CAS) were applied twice, at the beginning and at the end of the trial.

The attention test (WISC) was applied four times: at the end and at the beginning of each period of musical intervention.

The green bar represents a period of three weeks in which the musical method was applied every school day, first thing in the morning before classes began.

Campbell’s and Stanley’s “Quasiexperimental Design” was used because the school was unwilling to randomize the groups. The absence of control group was compensated by the mixed longitudinal design here and the dose-response finding.

grafico1_ensayoclinico

grafico2_ensayoclinico

Design of Group A:

78 Children from second to sixth grade, between 7 and 12 years old with a diagnosis of ADHD: 

–  13 girls and 65 boys.

–  14 children from second grade, 14 from third, 16 from fourth, 17 from fifth and 18 from sixth.

–  36 medicated (Ritalin/Strattera)

–  43 unmedicated.

Note: Data and results from Group B (78 children) are also available, and I would be pleased to share them with anyone interested. However, they are intentionally not included here because in addition to a diagnosis of ADHD, they were diagnosed with another pathology.


Duration of the Clinical Trial:

3 periods of 3 weeks each: weeks 1 to 3 and weeks 7 to 9 with musical intervention. Weeks 4 to 6 without. 

The students were given the attention test four times (A1, A2, A3, A4) and they were given the anxiety tests, STAIC and CAS, twice (A1, A4)

So there were three interval change scores, corresponding to the change from test 1 to test 2, test 2 to test 3, test 3 to test 4, and there was also an overall change score from test 1 to test 4.

The graph below (Prof. Bookstein) shows the change from test 1 to test 4. :

grafico3_ensayoclinico

The dark line in the graph is the average for each test score. It shows an extraordinary upward progression, with important changes over the two periods of exposure to the stimulus tapes and no evident regression during the interval from measure 2 to measure 3, when no musical stimulus was applied.

All the raw data for the 78 subjects in Group A who had all four test scores are represented in the graph. The scores use the full range of the Attention Scale, from 1 to 19 (range of raw Wechsler scores on any subscale).

The prevalence of scores for the first test fall below the level of 10, which is in the middle of the attention test score range, whereas the prevalence of the scores at the fourth measurement fall above ten.The following table plots the change scores for each child separately:


Change score
-5 -3 -2 0 1  2 3 4 5  6 7 8 9 11 13
Number of children  1  2  1 3 8 11 9 7 4 13 8 5 3   2   1

Of the 78 children with complete data, only 4 had a change score below zero. For 3, the score remained unchanged. Yet for 71 of the 78 children, there was significant improvement over the nine weeks of the clinical trial.


Conclusions:
Hypothesis 1: It has been demonstrated that the MUSICAL METHOD IMPROVED SUSTAINED ATTENTION in an extraordinary way.
Hypothesis 2: It has been demonstrated that the MUSICAL METHOD HAD A DOSE-RESPONSE EFFECT.
Hypothesis 3: It has been demonstrated that the MUSICAL METHOD REDUCED THE CHILDREN’S STATE OF ANXIETY SIGNIFICANTLY.

1. EXTRAORDINARY IMPROVEMENT IN SUSTAINED ATTENTION
Total average variation in sustained attention
= 12.8 – 8.6= 4.2
S.D. (variación individual)
= 3.95
Effect size standard
= 4.2/3.95 = 1.07

An enormous value within the parameters of evolutive psychology.
The variance of the sample of the dependent variable goes from 0 a 19.

*Effect size: mean of the experimental group – mean of the control group/ standard deviation.

2. DOSE-RESPONSE EFFECT WAS DEMOSTRATED: the effect of two doses appears to be just about double the effect of one dose.

3. SIGNIFICANT REDUCTION OF CHILDREN’S STATE OF ANXIETY.


SAMPLE 1:

*28 CHILDREN from 7 to 8 YEARS OLD FROM GROUP A (2nd and 3rd grades of primary school), TESTED WITH CAS*, (Cuestionario de Ansiedad Infantil) twice, at the beginning and end of the clinical trial.

*Through the use of an easy-to-apply and interpret questionnaire, CAS enables profound psychological exploration into anxiety disorders that affect children in the first levels of school. CAS requires basic information and is able to be applied several times in order to control the possible emotional repercussions of particular situations.

The table shows the change score of each tested child:

Change score
-40 -24 -23 -19 -11 -1 0 11 12 17 18 19 31 34 36 40
 Number of children
   1    1    2    1    1  1 2   2   1   1   1   2   1   2   1   1
Change score  45 47 48 55 56 58 86
 Number of children
  1   2   1   1   1   1   1

Of the 28 children with complete data, 7 showed a change score below zero; 2 children showed no change; 19 showed a reduction in anxiety states during the period of the clinical trial. Therefore, 70% of the children from 7 to 9 years old considerably decreased their levels of anxiety during the clinical trial.

The average variation in state anxiety fell 18.75.

 


SAMPLE 2:

48 CHILDREN FROM 9 TO 12 YEARS OLD FROM GROUP A (4th and 6th grades of primary school), TESTED USING STAIC* at the beginning and at the end of the clinical trial.

*STAIC is a self-administered measure of two distinct types of anxiety, state and trait. Each concept of anxiety is measured in a separate, 20-statement test; in State Anxiety (S/A): the child expresses “how he/she feels at a particular moment in time,” and measures transitory anxiety states: subjective, consciously perceived feelings of apprehension, tension and worry that vary in intensity and fluctuate over time. Trait Anxiety (T/A): the child expresses “how he/she generally feels.” The test measures stable individual differences in anxiety proneness, or, differences between children in the tendency to experience anxiety states.

Change score in state anxiety of  the 48 children:


Change score -50 -15 -10 -5   0 5 7 8 9 10 15 19 25 40 45 48
 Number of children
   1    1    2  4 16 5 1 2 1   2   2   1   1   1   1   1
Change score
50 60 85 97
 Number of children
  1   1   2   1

Of the 48 children with complete data, 24 showed an improvement an improvement in state anxiety during the period of the clinical trail.  The effect size was 0.96, which is considered rather significant.

Change score in trait anxiety of  the 48 children:


Change score
-50 -40 -30 -25 -1 -15 -10 -8 -5 -3 0 1 2 5 9 10
 Number of children
   1    1    1    1   1    1    1   1   1   1 7 1 1 3 1 1
Change score
15 20 21 25 30 34 35 39 40 45 49 64 67 68 75
 Number of children
  2   3   1   2   1   1   1   1   1   1   1   2   1   1   1

Of the 48 children with complete data, 27 showed (56,25%) an improvement in trait anxiety during the period of the clinical trial.

Although the results of the anxiety test are statistically significant, they are not as spectacular as the results of the sustained attention test.

También se analizó la muestra por grupos:

Resultados del ensayo clínico en niños con y sin medicación

36 niños estaban medicados con metilfenidato o atomoxetina,
El efecto de la muestra del grupo medicado fue de 0,9, un valor importante (Cohen, 1998).
El efecto de la muestra del grupo no medicado (n = 42 total) fue de 1,24, que es un efecto enorme.

Podemos concluir que los niños sin ninguna medicación eran más receptivos a la intervención musical que los niños medicados. Sin embargo, es evidente que la diferencia no es significativa, ya que ambos grupos muestran un efecto importante.

Resultados del ensayo clínico en el grupo dividido por sexos.

64 niños consiguieron un efecto de tamaño de 1,02
y 14 niñas un efecto de 1,28.

Aunque la muestra de las niñas parece pequeña es consistente con los informes que sostienen que el TDA/H es de 2 a 4 veces más frecuente en niños que en niñas (Dulcan de 1997, Singh, 2008).

Resultados del ensayo clínico en el grupo dividido por cursos y edades.

Se obtuvo un tamaño del efecto de 1,35 en Segundo de Primaria, es decir, en niños de 7 y 8 años.

Un tamaño de efecto de 1 en Tercero de Primaria (8 y 9 años).

El grupo de Cuarto, con de 9 a 10 años obtuvo un tamaño del efecto de 2,54, que es enorme.

En Quinto de Primaria 5, niños de 10 y 11 años, el tamaño del efecto fue de 0,70, algo menor que en otros cursos, pero sigue siendo elevado (Cohen, 1988).

Sexto de Primaria, 11 y 12 años, tenía un tamaño del efecto de 1,41, que también es importante.


Conclusión:

Este método es eficaz, rentable, versátil y fácil en su uso. Además carece de efectos secundarios.


RESULTADOS: EXCELENTE MEJORA DE LA ATENCIÓN SOSTENIDA

–  Variación media  en la ATENCIÓN SOSTENIDA:

–  1,62 en el primer tramo, 0,30 en el segundo, 2,17 en el tercero
–  4,2 en total

assessment

EXCELENTE MEJORA DE LOS ESTADOS DE ANSIEDAD

El 70% de los niños de 7 a 10 años mejoraron notablemente en los índices de ansiedad durante el ensayo clínico
CAS

EXCELENTE MEJORA DE LOS ESTADOS DE ANSIEDAD

El 60% de los niños de 10 a 12 años mejoraron notablemente en los índices de ansiedad durante el ensayo clínico.
Ansiety


Este método es eficaz, rentable, versátil y fácil en su uso. Además carece de efectos secundarios.

atencion_v9

 

yourattentionplease | Crecer con confianza.
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