Ignite Creation Date:
2024-05-06 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03618563
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2018-07-10
Brief Title:
Developing and Evaluating a Meta-cognitive Intervention Amongst Adolescents With Neuro-development Disabilities
Sponsor:
Sara Rosenblum
Organization:
University of Haifa
Study Overview
Official Title:
Developing and Evaluating a Meta-cognitive Intervention Amongst Adolescents With Neuro-development Disabilities
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FITTED
Brief Summary:
Adolescents with neuro-developmental disabilities such as attention deficit hyperactive disorder ADHD specific learning disabilities LD and developmental coordination disorder DCD display functional difficulties in all performance areas daily functions learning playing leisure activities and social participation These problems hinder their ability to perform and participate effectively in everyday life
Difficulties in meta-cognitive components particularly Executive Functions EF are the underlying mechanisms of these disorders and challenge the functioning of this population Therefore it is important to refer them to occupational therapists specializing in daily functions and individualized intervention The proposed model for assessment and therapy Functional Individualized Therapy for Teenagers with Executive Deficits FITTED takes into account the environmental requirements the person the adolescent and his pertinent issues this in accordance with the classifications of the International Classification of Functioning Disability and Health for Children and Youth ICF-CY WHO 2007 World Health Organization the occupational model and dynamic meta-cognitive models FITTED serves as a basis for an individual evaluation and intervention program that emphasizes the individuals personal strengths and weaknesses in daily functions Body functions meta-cognitive - EF and awareness Activity in various fields and Participation in daily functions The model will serve as a guide for an intervention program that will be based upon determining functional goals and achievement of these goals through meta-cognitive strategies that will allow adolescents optimal participation in their environments
Difficulties in meta-cognitive components particularly Executive Functions EF are the underlying mechanisms of these disorders and challenge the functioning of this population Therefore it is important to refer them to occupational therapists specializing in daily functions and individualized intervention The proposed model for assessment and therapy Functional Individualized Therapy for Teenagers with Executive Deficits FITTED takes into account the environmental requirements the person the adolescent and his pertinent issues this in accordance with the classifications of the International Classification of Functioning Disability and Health for Children and Youth ICF-CY WHO 2007 World Health Organization the occupational model and dynamic meta-cognitive models FITTED serves as a basis for an individual evaluation and intervention program that emphasizes the individuals personal strengths and weaknesses in daily functions Body functions meta-cognitive - EF and awareness Activity in various fields and Participation in daily functions The model will serve as a guide for an intervention program that will be based upon determining functional goals and achievement of these goals through meta-cognitive strategies that will allow adolescents optimal participation in their environments
Detailed Description:
Research Aims
1 To construct a theoretical model from existing literature for researchers and clinicians in the field of adolescents with neuro-developmental disorders
2 To examine the effectiveness of the model through an intervention process that includes assessment and treatment of adolescents with neuro-developmental disorders
Hypotheses
The study involved two main groups
1 The Research Group - a group of adolescents with neurodevelopmental deficiencies n 41 divided into two sub-groups A Research group A n 21 - received treatment immediately after the first assessment B Research group B n 20 - was reassessed eight weeks after the first assessment the length of the treatment process and then received treatment Both research groups were reassessed at the end of the treatment second assessment for Group A and third assessment for group B An additional assessment was performed three months after the end of treatment
2 The Control Group - typical adolescents n 40 Assessed once
The hypotheses are presented in three stages
Stage 1
1 A comparison of the characteristics of the subjects of the research groups A and B as a preliminary stage to their unification as one control group n41 Hypothesis 1 Differences will not be found in the demographic variables and daily functions when assessed using CHECK the questionnaire and the level of control in EF in the assessment using the BRIEF questionnaire
2 To examine the change in research group B n 20 prior to treatment Hypothesis 2 Differences will not be found between assessment 1 and assessment 1a before the treatment in the following variables 2 a The level of awareness of the subject in execution of daily activities writing task of copying a passage from the Israeli handwriting quality diagnosis for junior high schools and preparation of a cake and drink from the CCT assessment tool 2 b The control of EF BRIEF questionnaires and a WebNeuro assessment 2 c Execution of activities that reflect daily functions copying a passage from the Israeli handwriting quality diagnosis for junior high schools and preparation of a cake and drink from the CCT diagnostic tool 2 d Participation in activities in the home environment in school and the community PEM-CY questionnaire
Stage 2
Characteristics of the Participants
1 A comparison of the demographic personal family developmental and educational characteristics of members of the research group n 41 with those of the control group n 40 and a comparison of the characteristics of the research variables before treatment Hypothesis 3 Significant differences will be found between the research group and the control group in the demographic personal family developmental and educational variables Hypothesis 4 Significant differences between the research group and the control group with advantages to the control group in 4 a Awareness levels of the adolescent before the execution of daily activities writing task of copying a passage from the Israeli handwriting quality diagnosis for junior high schools and preparation of a cake and drink from the CCT diagnostic tool 4 b Control of EF BRIEF questionnaires and a WebNeuro assessment 4 c Execution of activities that reflect daily functions copying a passage from the Israeli handwriting quality diagnosis for junior high schools and preparation of a cake and drink from the CCT diagnostic tool 4 d Participation in leisure activities and activities in the home environment in school and the community PEM-CY questionnaire
2 Description of treatment goals selected by the participants of the research groups n 41 in the treatment process
Stage 3
Effectiveness of the Treatment
1 Examination of the effectiveness of the treatment process within in the research group n 41 Hypothesis 5 Significant differences will be found in the research group n 41 before and after treatment in 5 a The adolescents level of awareness before performing daily life activities copying a passage from the Israeli handwriting quality diagnosis for junior high schools and preparation of a cake and drink from the CCT diagnostic tool 5 b Control of EF BRIEF questionnaires and a WebNeuro assessment 5 c Performing activities that reflect daily functioning copying a passage from the Israeli handwriting quality diagnosis for junior high schools and preparation of a cake and drink from the CCT diagnostic tool 5 d Participation in activities in the home environment in school and the community PEM-CY questionnaire
2 Examination of the effectiveness of the treatment three months after its completion n 41 Hypothesis 6 Differences will be found in the research group before and after treatment and after a follow-up assessment three months later 6 a Control of EF BRIEF questionnaires 6 b Participation in activities in the home environment in school and the community through PEM-CY questionnaire
3 An evaluation of the effectiveness of the treatment in the context of the goals chosen by the adolescent before beginning the treatment
Hypothesis 7
7 Differences will be found in the research group in the adolescents evaluation of his execution in treatment goals as rated with the COPM and GAS before during and after the treatment and in the follow-up three months later 4 A prediction of characteristics of the adolescents performance after treatment using meta-cognitive variables that were examined before treatment as reported by adolescents and parents Hypothesis 8 The level of control of EF BRIEF questionnaire and a WebNeuro assessment and awareness predictive awareness and awareness to assessment of time as reported and executed by the adolescent at the beginning of treatment will predict
8 a The execution of daily activities such as preparing a cake and a drink as part of the CCT diagnosis 8 b The execution of daily activities as assessed through the writing task of copying a passage from the Israeli handwriting quality diagnosis for junior high schools total time amount of time the pen was on the paper and in the air Hypothesis 9 The level of control in EF as reported by parents at the beginning of treatment through the BRIEF questionnaire would predict 9 a Execution of daily activities such as preparing a cake and a drink as part of the CCT diagnosis - after treatment 9 b Execution of daily activities assessed through the writing task of copying a passage from the Israeli handwriting quality diagnosis for junior high schools total time amount of time the pen was on the paper and in the air - after treatment
Method Participants Eighty-one adolescents aged 10-18 were accepted to the study according to the inclusion criteria The participants were divided into two main research groups the research group n41 and the control group n40 matched by age and gender The research group was tested with a Randomized Control Trial RCT The participants were found through extensive publication regarding the research The study included adolescents with deficits in everyday activities according to their parents reports in the Child Evaluation Checklist CHECK questionnaires and EF deficits as reported by their parents in the Behavior Rating Inventory of Executive Function BRIEF score of 65 and higher Tools an evaluation was performed to examine the effectiveness of the intervention on daily functions a Toglia questionnaire 2011 measured awareness a WebNeuro was used for the neuropsychological testing and BRIEF questionnaires for parents and the adolescents were used to examine the manifestation of executive functions in daily life Performance of everyday tasks was measured through a writing task of copying an excerpt from the Israeli handwriting diagnostics for junior high schools and preparation of a cake and a drink as part of the Childrens Cooking Task CCT
Participation in the home at school and in the community were assessed with the Participation Measure and Environment for Children and Youth PEM-CY questionnaire Moreover the Canadian Occupational Performance Measure - COPM and - Goal Attainment Scaling - GAS were used to assess implementation of the selected treatment goals and satisfaction with performance Extensive information on the medical developmental personal and educational history and of the subjects was also gathered Procedure The study was carried out between the years 2012 and 2015 by two researchers one performed the assessments and the chief researcher executed the intervention processes One group n21 was the first to receive the intervention immediately after the primary evaluation and the second group n20 waited during the assessment period and after a second assessment began treatment The participants were reassessed after treatment and once again three months later Data processing A MANOVA was performed with SPSS-21 to examine the differences between the indices of the research and control groups after their first assessments Repeated Measures tests were performed in order to measure test hypotheses about differences in the functioning of members of the research group before and after intervention and in the follow-up Regression tests were conducted to examine the predictions
1 To construct a theoretical model from existing literature for researchers and clinicians in the field of adolescents with neuro-developmental disorders
2 To examine the effectiveness of the model through an intervention process that includes assessment and treatment of adolescents with neuro-developmental disorders
Hypotheses
The study involved two main groups
1 The Research Group - a group of adolescents with neurodevelopmental deficiencies n 41 divided into two sub-groups A Research group A n 21 - received treatment immediately after the first assessment B Research group B n 20 - was reassessed eight weeks after the first assessment the length of the treatment process and then received treatment Both research groups were reassessed at the end of the treatment second assessment for Group A and third assessment for group B An additional assessment was performed three months after the end of treatment
2 The Control Group - typical adolescents n 40 Assessed once
The hypotheses are presented in three stages
Stage 1
1 A comparison of the characteristics of the subjects of the research groups A and B as a preliminary stage to their unification as one control group n41 Hypothesis 1 Differences will not be found in the demographic variables and daily functions when assessed using CHECK the questionnaire and the level of control in EF in the assessment using the BRIEF questionnaire
2 To examine the change in research group B n 20 prior to treatment Hypothesis 2 Differences will not be found between assessment 1 and assessment 1a before the treatment in the following variables 2 a The level of awareness of the subject in execution of daily activities writing task of copying a passage from the Israeli handwriting quality diagnosis for junior high schools and preparation of a cake and drink from the CCT assessment tool 2 b The control of EF BRIEF questionnaires and a WebNeuro assessment 2 c Execution of activities that reflect daily functions copying a passage from the Israeli handwriting quality diagnosis for junior high schools and preparation of a cake and drink from the CCT diagnostic tool 2 d Participation in activities in the home environment in school and the community PEM-CY questionnaire
Stage 2
Characteristics of the Participants
1 A comparison of the demographic personal family developmental and educational characteristics of members of the research group n 41 with those of the control group n 40 and a comparison of the characteristics of the research variables before treatment Hypothesis 3 Significant differences will be found between the research group and the control group in the demographic personal family developmental and educational variables Hypothesis 4 Significant differences between the research group and the control group with advantages to the control group in 4 a Awareness levels of the adolescent before the execution of daily activities writing task of copying a passage from the Israeli handwriting quality diagnosis for junior high schools and preparation of a cake and drink from the CCT diagnostic tool 4 b Control of EF BRIEF questionnaires and a WebNeuro assessment 4 c Execution of activities that reflect daily functions copying a passage from the Israeli handwriting quality diagnosis for junior high schools and preparation of a cake and drink from the CCT diagnostic tool 4 d Participation in leisure activities and activities in the home environment in school and the community PEM-CY questionnaire
2 Description of treatment goals selected by the participants of the research groups n 41 in the treatment process
Stage 3
Effectiveness of the Treatment
1 Examination of the effectiveness of the treatment process within in the research group n 41 Hypothesis 5 Significant differences will be found in the research group n 41 before and after treatment in 5 a The adolescents level of awareness before performing daily life activities copying a passage from the Israeli handwriting quality diagnosis for junior high schools and preparation of a cake and drink from the CCT diagnostic tool 5 b Control of EF BRIEF questionnaires and a WebNeuro assessment 5 c Performing activities that reflect daily functioning copying a passage from the Israeli handwriting quality diagnosis for junior high schools and preparation of a cake and drink from the CCT diagnostic tool 5 d Participation in activities in the home environment in school and the community PEM-CY questionnaire
2 Examination of the effectiveness of the treatment three months after its completion n 41 Hypothesis 6 Differences will be found in the research group before and after treatment and after a follow-up assessment three months later 6 a Control of EF BRIEF questionnaires 6 b Participation in activities in the home environment in school and the community through PEM-CY questionnaire
3 An evaluation of the effectiveness of the treatment in the context of the goals chosen by the adolescent before beginning the treatment
Hypothesis 7
7 Differences will be found in the research group in the adolescents evaluation of his execution in treatment goals as rated with the COPM and GAS before during and after the treatment and in the follow-up three months later 4 A prediction of characteristics of the adolescents performance after treatment using meta-cognitive variables that were examined before treatment as reported by adolescents and parents Hypothesis 8 The level of control of EF BRIEF questionnaire and a WebNeuro assessment and awareness predictive awareness and awareness to assessment of time as reported and executed by the adolescent at the beginning of treatment will predict
8 a The execution of daily activities such as preparing a cake and a drink as part of the CCT diagnosis 8 b The execution of daily activities as assessed through the writing task of copying a passage from the Israeli handwriting quality diagnosis for junior high schools total time amount of time the pen was on the paper and in the air Hypothesis 9 The level of control in EF as reported by parents at the beginning of treatment through the BRIEF questionnaire would predict 9 a Execution of daily activities such as preparing a cake and a drink as part of the CCT diagnosis - after treatment 9 b Execution of daily activities assessed through the writing task of copying a passage from the Israeli handwriting quality diagnosis for junior high schools total time amount of time the pen was on the paper and in the air - after treatment
Method Participants Eighty-one adolescents aged 10-18 were accepted to the study according to the inclusion criteria The participants were divided into two main research groups the research group n41 and the control group n40 matched by age and gender The research group was tested with a Randomized Control Trial RCT The participants were found through extensive publication regarding the research The study included adolescents with deficits in everyday activities according to their parents reports in the Child Evaluation Checklist CHECK questionnaires and EF deficits as reported by their parents in the Behavior Rating Inventory of Executive Function BRIEF score of 65 and higher Tools an evaluation was performed to examine the effectiveness of the intervention on daily functions a Toglia questionnaire 2011 measured awareness a WebNeuro was used for the neuropsychological testing and BRIEF questionnaires for parents and the adolescents were used to examine the manifestation of executive functions in daily life Performance of everyday tasks was measured through a writing task of copying an excerpt from the Israeli handwriting diagnostics for junior high schools and preparation of a cake and a drink as part of the Childrens Cooking Task CCT
Participation in the home at school and in the community were assessed with the Participation Measure and Environment for Children and Youth PEM-CY questionnaire Moreover the Canadian Occupational Performance Measure - COPM and - Goal Attainment Scaling - GAS were used to assess implementation of the selected treatment goals and satisfaction with performance Extensive information on the medical developmental personal and educational history and of the subjects was also gathered Procedure The study was carried out between the years 2012 and 2015 by two researchers one performed the assessments and the chief researcher executed the intervention processes One group n21 was the first to receive the intervention immediately after the primary evaluation and the second group n20 waited during the assessment period and after a second assessment began treatment The participants were reassessed after treatment and once again three months later Data processing A MANOVA was performed with SPSS-21 to examine the differences between the indices of the research and control groups after their first assessments Repeated Measures tests were performed in order to measure test hypotheses about differences in the functioning of members of the research group before and after intervention and in the follow-up Regression tests were conducted to examine the predictions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None