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

ISRCTN	ISRCTN81710297
DOI	https://doi.org/10.1186/ISRCTN81710297
Protocol serial number	FDG_BIF_MCNT
Sponsor	Fondazione Don Gnocchi - Centro IRCCS S. Maria Nascente
Funder	Regione Lombardia Italy (Lombardy regional government)

Submission date: 16/12/2016
Registration date: 09/01/2017
Last edited: 11/05/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Borderline intellectual functioning (BIF) is a catagory of intelligence when a person's intellectual ability is lower than average but not low enough to be an intellectual disability. It affects 7-12% of primary school children and is usually shown through difficulties at school due to poor problem solving, planning and memory skills. In some, language movement and social abilities can also be affected, making it difficult to take part in normal activities. BIF can be caused by many factors, including coming from a disadvantaged background, difficulties at home or prematurity. Dropping out of school and mental problems such as anxiety and depression are common in children with BIF. This study is testing whether an intensive programme which involves all of the areas affected in BIF children (Movement, mental processing, emotions) is more effective than standard speech therapy in children with BIF.

Who can participate?
Children aged between 6 to 11 years who attend a mainstream primary school and have multiple learning difficulties associated to behavioral problems

What does the study involve?
Participants are randomly allocated to one of three groups. Those in the first group receive individual treatment with SST for 45 minutes, twice a week for 9 months. This involves a training of the academic abilities such as reading, writing, arithmetic and language comprehension. Those in the second group receive the experimental treatment MCNT for 3 hours per day, 5 days/ week for 9 months and work in small groups of 5-6 children each. The MCNT consists of: a) Movement training to improve fine and gross motor abilities with a Game Therapy approach; b) Cognitive training for empowerment of reasoning and memory abilities with the use of the multimedia interactive whiteboard; and c)an emotion training to learn how to Narrate the emotions to help the child to cope with the experiences of her/his daily life. The third group consists of children on a waiting list for the SST for nine months.

What are the possible benefits and risks of participating?
Participants can benefit from a standard or an experimental treatment if they are allocated in one of the two treatment groups. No notable risks are associated with the participation to this study.

Where is the study run from?
1. Fondazione Don C. Gnocchi Onlus, IRCCS "S.M. Nascente" (Italy)
2. Ospedale San Paolo (Italy)

When is the study starting and how long is it expected to run for?
December 2014 to December 2017

Who is funding the study?
Lombardy Region (Italy)

Who is the main contact?
Dr Valeria Blasi
vblasi@dongnocchi.it

Contact information

Dr Valeria Blasi
Scientific

Fondazione Don Gnocchi - Centro IRCCS S. Maria Nascente
Via Alfonso Capecelatro, 66
Milan
20148
Italy

ORCID ID	0000-0002-8395-0452

Dr Gisella Baglio
Scientific

Fondazione Don Gnocchi - Centro IRCCS S. Maria Nascente
Via Alfonso Capecelatro, 66
Milano
20148
Italy

Phone	+39 02 40308074
Email	gbaglio@dongnocchi.it

Study information

Primary study design	Interventional
Study design	Multi-centre interventional single-blind three-arm randomized controlled study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	MCNT
Study objectives	An intervention that is intensive (3 hours per day, 5 days/ week for 9 months) and multimodal so to include all compromised domains would be more effective than the Standard Speech Therapy (SST, 45 minutes, twice a week for 9 months) to improve global intelligence to reverse the course of such a complex developmental condition.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	Borderline Intellectual Functioning (BIF)
Intervention	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 foster verbal comprehension, memory encoding and storage processes. With both devices, moreover, it is possible to promote little competitions among children which are very effective to motivate the child and to improve information speed processing, positive interdependency and frustration tolerance. Finally, to help the child to narrate the emotions, a psychotherapist promotes several activities such as the narration of fairy tales, or the drawing and the symbolic playing to create a new story, to promote the capacity to think and to recognize the emotions. Group three: Participants receive no additional treatment and continue as normal for the nine month duration of the study. Participants in all groups are followed up within two months after the end of the treatment .
Intervention type	Behavioural
Primary outcome measure(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
Key secondary outcome measure(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
Completion date	12/12/2017

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Years
Upper age limit	11 Years
Sex	All
Target sample size at registration	60
Key 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
Key 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
Date of first enrolment	01/01/2015
Date of final enrolment	31/07/2016

Locations

Countries of recruitment

Italy

Study participating centres

Fondazione Don C. Gnocchi Onlus, IRCCS "S.M. Nascente"

Via Capecelatro 66
Milano
20148
Italy

Ospedale San Paolo

A. Di Rudinì, 8
Milano
20142
Italy

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during the current study will be available upon request from vblasi@dongnocchi.it

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/04/2020	11/05/2020	Yes	No
Protocol article	protocol	20/04/2017		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

11/05/2020: Publication reference added.
24/04/2017: Publication reference added.