Let them grow: a new intensive and multimodal treatment for children with borderline intellectual functioning based on movement, cognition and narration of emotions

• Register: ISRCTN
• Last refreshed on: 25 May 2020
• Main ID: ISRCTN81710297
• Date of registration: 09/01/2017
• Prospective Registration: No
• Primary sponsor: Fondazione Don Gnocchi - Centro IRCCS S. Maria Nascente
• Public title: Let them grow: a new intensive and multimodal treatment for children with borderline intellectual functioning based on movement, cognition and narration of emotions
• Scientific title: Comparison between a new intensive and multimodal Treatment based on Movement, Cognition and Narration of emotions (MCNT) and standard speech therapy to improve global intelligence in children with borderline intellectual functioning
• Date of first enrolment: 01/01/2015
• Target sample size: 60
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN81710297
• Study type: Interventional
• Study design: Multi-centre interventional single-blind three-arm randomized controlled study (Treatment)
• Phase: Not Applicable

Countries of recruitment

Italy

Contacts

• Name: Valeria Blasi

Key inclusion & exclusion criteria

Inclusion criteria:
1. Aged between 6 to 11 years old and attending primary mainstream school
2. Full Scale Intelligence Quotient score ranging from 71 to 85 determined with the WISC-III
3. Presence of learning disabilities assessed with the standardized test battery for developmental dyslexia and dysorthographia and dyscalculia
4. Difficulties in executive functions and or verbal comprehension assessed with Modified Barrage bell test;Tower of London (TOL) and the Test of Reception of Grammar (TROG2)
5. Presence of an impact on daily life of the above mentioned difficulties as measure by the Child Behavioral Checklist and Vineland2

Exclusion criteria:
1. Presence of major neuropsychiatric disorders (such as ADHD and autism spectrum disorder)
2. Presence of neurological conditions:epilepsy; traumatic brain injury; brain malformations; infectious disease involving the central nervous system
3. Presence of systemic diseases such as diabetes or dysimmune disorders
4. Presence of genetic syndromes such as Down syndrome or Fragile X syndrome
5. Positive history for psychoactive drugs, particularly referring to current or past use of psychostimulants, neuroleptics, antidepressants, benzodiazepines and antiepileptic drugs


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Borderline Intellectual Functioning (BIF)
Mental and Behavioural Disorders
Borderline Intellectual Functioning (BIF)

Intervention(s)

Participants are randomised to one of three groups using a computer algorithm (http://graphpad.com) by an independent operator not involved in neither phase of our research.

Group one: Participants receive two 45-minute sessions of individual SST per week for nine months. SST focuses on training academic abilities which are compromised in the child as assessed by the neuropsychological evaluation at T0 (pre treatment). Typically, the skills mostly involved are text reading comprehension, word-meaning relationship (semantics); writing problems related to the letter-to-sound relationship (phonics), arithmetic abilities and problem solving.

Group two: Participants receive five three-hour sessions of MCNT in small groups (5-6 children) per week for nine months. MCNT focuses on the three domains affected in children with BIF and that are strictly embedded with learning abilities: motor, cognitive and socio-emotional domain. This treatment consists of:
1. Movement training to improve fine and gross motor abilities with a Game Therapy approach with the use of the Wii and Xbox platforms
2. Cognitive training for the empowerment of the executive functions such as working memory, planning abilities, problem solving, reasoning with the use of the multimedia interactive whiteboard (MIW)
3. Emotion training to learn how to Narrate the emotions to help the child to cope with the experiences of her/his daily life.
The technology devices mentioned above are used because they are able to capture attention and are highly motivating for the child. In addition, the use of the MIW represents a visual aid very useful for a visually-oriented teaching strategy that is effective to

Primary Outcome(s)

All outcome measures are performed at two time points: within two months prior to the beginning of the treatment (T0) and within two months after the end of the treatment (T1).

1. Intellectual functioning is assessed with the Wechsler Intelligent Scale for Children-III (WISC-III) at T0 and T1
2. Movement skills is assessed with Movement Assessment Battery for Children (M-ABC) at T0 and T1
3. Emotional intelligence is assessed with the Emotional Quotient Inventory-Youth Version at T0 and T1
4. Child behavior is assessed with the Child Behaviour CheckList 6-18, CBCL and Vineland 2 at T0 and T1

Secondary Outcome(s)

All outcome measures are performed at two time points: within two months prior to the beginning of the treatment (T0) and within two months after the end of the treatment (T1).

1. Executive function is assessed using the Modified Bells Test (to assess selective attention), the Tower of London test (to assess planning ability and inhibitory control) and the Neuropsychological Evaluation Battery for developmental age 5-11 (to assess speech fluency) at T0 and T1
2. Language comprehension is assessed using the Test of Reception of Grammar-2 (TROG2) at T0 and T1
3. Memory is assessed using selective word retrieval and visual memory is assessed with the Corsi Test using Neuropsychological Evaluation Battery for developmental (age 5-11) at T0 and T1
4. Modifications of brain function and morphology are evaluated with magnetic resonance imaging advanced techniques, such as diffusion tensor imaging (DTI), functional MRI (fMRI), resting state fMRI and high resolution volumetric acquisition at T0 and T1

Secondary ID(s)

FDG_BIF_MCNT

Source(s) of Monetary Support

Regione Lombardia Italy (Lombardy regional government)

Ethics review

Status:
Approval date:
Contact:

The Ethics Committee of the Section of the "IRCCS Don Carlo Gnocchi Foundation" of the IRCCS Central Ethics Committee of Lombardy Region Italy (Il “Comitato Etico della Sezione "IRCCS Fondazione Don Carlo Gnocchi" del comitato etico centrale IRCCS Regione Lombardia”), 18/02/2015

Results

• Results available: Yes
• Date Completed: 12/12/2017