CTRI/2024/10/075546 [Registered on: 21/10/2024] Trial Registered Prospectively
Last Modified On:
04/10/2024
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Behavioral
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Mindfulness in adolescents with ADHD
Scientific Title of Study
Development of a mindfulness-based intervention for adolescents with ADHD
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Anusha Thakur
Designation
PhD Scholar
Affiliation
AIIMS, New Delhi
Address
Department of Psychiatry, AIIMS, New Delhi
South DELHI 110029 India
Phone
9313181455
Fax
Email
anushathakur@aiims.edu
Details of Contact Person Scientific Query
Name
Bichitra Nanda Patra
Designation
Additional Professor
Affiliation
Department of Psychiatry, AIIMS, New Delhi
Address
Room no. 4096, Department of Psychiatry, Teaching block, AIIMS, New Delhi
South DELHI 110029 India
Phone
9717880196
Fax
Email
patrab.aiims@gmail.com
Details of Contact Person Public Query
Name
Anusha Thakur
Designation
PhD Scholar
Affiliation
AIIMS, New Delhi
Address
Department of Psychiatry, AIIMS, New Delhi
DELHI 110029 India
Phone
9313181455
Fax
Email
anushathakur@aiims.edu
Source of Monetary or Material Support
CSRI Scheme, Department of Science and Technology, Government of India
Technology Bhawan, New Mehrauli Road, Block C, Qutub Institutional Area, New Delhi, India-110016
Primary Sponsor
Name
Department of Science and Technology, Government of India
Address
Technology Bhavan, New Mehrauli Road,, New Delhi
Department of Science & Technology, Technology Bhavan, New Mehrauli Road,, New Delhi-110 016.
Type of Sponsor
Government funding agency
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Bichitra Nanda Patra
All India Institute of Medical Sciences (AIIMS), New Delhi
Child & Adolescent Psychiatry OPD, Department of Psychiatry,New Rajkumari Amrit Kaur OPD, AIIMS, New Delhi South DELHI
Behavioural parent training for parents and behavioural modification for adolescents
8-week behavioural parent training and behavioural modification for adolescents to be given in group settings for a duration and number of sessions equivalent to the mindfulness-based intervention
Intervention
Mindfulness-based intervention
8-week mindfulness-based psychotherapeutic intervention to be developed as a part of the study to be delivered in parallel groups of parents and their children who have been diagnosed with ADHD
Inclusion Criteria
Age From
10.00 Year(s)
Age To
17.00 Year(s)
Gender
Both
Details
Adolescents
Child aged 10-17 years
Clinical diagnosis of ADHD as per DSM-5
Child having an estimated IQ≥80
Willing to give written assent
Not receiving any other psychotherapeutic intervention in the past year
Parents
Stay with the child for at least the past one year, and actively involved in the child’s issues
Ability to comprehend instructions
Willing to give informed written consent
Ability to read and write
Willing to attend at least 75% of the sessions
ExclusionCriteria
Details
Adolescents
• Unable or unwilling to give written assent
• Current or past history of gross psychiatric or medical symptoms that would hinder the therapeutic process
• History of neurodevelopmental disorders other than ADHD and Specific Learning Disorder (SLD)
Parents
• Unwilling or unable to give informed written consent
• Unable to comprehend instructions
• More than one person in family having a chronic psychiatric illness
• Any known major psychiatric or medical illness that could hinder the delivery of the intervention
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Alternation
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
- ADHD severity through Conners Parent Form 4th ed
- Sustained and divided attention on Children Colour Trail Test
- Mindfulness in adolescents as measured through CAMM
Pre and post intervention
Secondary Outcome
Outcome
TimePoints
Clinical global impression
Child global assessment scale
Kidscreen-27
Family management measure
Five factor mindfulness questionnaire
Parental stress scale
Pre and post intervention
Target Sample Size
Total Sample Size="40" Sample Size from India="40" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
10/03/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
ADHD is characterised by inattention and hyperactivity. In India, the prevalence of ADHD is 7.1% (Joseph & Babita, 2019). Inattention has been found to be the most prominent symptom during adolescence. ADHD has also been proposed as a risk factor for several adolescent onset disorders, including mood disorders and substance use disorders (Shaw & Sudre, 2021). The efficacy of both medication and psychosocial interventions for the treatment of ADHD has been well-established. Stimulants are considered the first-line treatment. Dosreis et al. (2003) found that non-Caucasian parents reported concerns over the negative side effects of stimulants. Other factors associated with the discontinuation of medication in children included a dislike of taking pills, stigma experiences and lowered self-esteem (Charach et al., 2006). These factors have led to an increased interest in non-pharmacological approaches.
Mindfulness is an emerging non-pharmacological intervention used with ADHD. Susan Bögels (2008) pioneered the use of mindfulness in ADHD interventions. Mindfulness can be used to manage the most prominent symptom of ADHD during adolescence, that is, inattention, and impulsivity can be both be addressed since it has been found to impact ADHD symptoms including attention and impulsivity, as well as associated neuro-cognitive deficits of attention and inhibition. It has been associated with reduction of negative affective reactivity and volatility in response to emotionally provocative events. This may be a result of the changes in attention regulation, body awareness, and emotion regulation produced by mindfulness.
Parents of children with ADHD experience significant stress and show less consistent parenting. Therefore, involving parents in a mindfulness-based interventions and teaching them the same skills would allow them to help the child apply mindfulness skills. In addition, it would also produce changes in their parenting patterns and parental stress.
Aim
The aim of the present study is to develop a mindfulness-based intervention for adolescents with ADHD and their parents.
Objectives
To develop a mindfulness-based intervention module for symptom improvement in adolescents with ADHD and their parents, and assess its feasibility
To evaluate the effect of the newly developed mindfulness-based intervention
Research Questions
Will a group mindfulness-based intervention be feasible to deliver to children with ADHD and their parents in Indian culture?
What will be the effect of the newly developed mindfulness-based intervention?
Hypotheses
The group mindfulness-based intervention will not be feasible in adolescents with ADHD and their parents.
There will be no beneficial effect of the new intervention on adolescents with ADHD.
Sample Description
The sample will be selected from adolescents visiting the Child and Adolescent Psychiatry (CAP) clinic of the Department of Psychiatry OPD of AIIMS, New Delhi.
Research Design
The study will be carried out in two phases:
Phase 1: Development of a mindfulness-based intervention and assessment of its feasibility: A cross-sectional design will be used.
Phase 2: Evaluating the effect of the newly developed intervention: A single blind randomised trial will be used.
Procedure
Phase 1: Development of a mindfulness-based intervention and assessment of its feasibility
Flow chart for phase 1
Stepsfor phase 1
Review of literature. A thorough literature search will be conducted to review the present findings and existing modules in order to assess their key components, usage with different populations and techniques utilised.
Key interviews with mindfulness experts.Interviews will be carried out till saturation of themes. A semi-structured interview guide will be prepared for this purpose with open ended questions covering the broad areas of the research objective for the key interviews. This will be evaluated by experts to check for the language and the ability to measure the broad research constructs. Review comments will be incorporated, and questions will be reframed accordingly. The key interviews will be transcribed for further analysis, using thematic analysis.
Selection criteria for participants in key interviews
Inclusion Criteria
Exclusion Criteria
Mental health practitioners using mindfulness-based interventionswith patients in India
Dealing with a child and adolescent clinical population
With at least 2 years of experience
Not willing to consent
Development of the initial provisional intervention module.An initial provisional intervention module will be developed based on the above findings and will be evaluated by experts for content validity. Changes suggested will be incorporated.
Pilot testing. The refined module will be delivered to one group of 5-6 participants selected using the following selection criteria. Baseline measurement will be done for the participants before the intervention and assessments will be repeated post intervention. Feasibility will be assessed using a structured questionnaire and visual analogue scales (VAS) after each session. A focused group discussion will be conducted with the participants at the end of the sessions. The discussion will be transcribed, and thematic analysis will be carried out.
Selection criteria
Selection criteria for the intervention
Inclusion criteria
Exclusion criteria
Adolescents
Child aged 10-17 years
Clinical diagnosis of ADHD as per DSM-5
Child having an estimated IQ≥80
Willing to give written assent
Not receiving any other psychotherapeutic intervention in the past year
Adolescents
Unable or unwilling to give written assent
Current or past history of gross psychiatric or medical symptoms that would hinder the therapeutic process
History of neurodevelopmental disorders other than ADHD and Specific Learning Disorder (SLD)
Parents
Stay with the child for at least the past one year, and actively involved in the child’s issues
Ability to comprehend instructions
Willing to give informed written consent
Ability to read and write
Willing to attend at least 75% of the sessions
Parents
Unwilling or unable to give informed written consent
Unable to comprehend instructions
More than one person in family having a chronic psychiatric illness
Any known major psychiatric or medical illness that could hinder the delivery of the intervention
Tools to be Used
Sociodemographic and clinical sheet.Containing information on age, gender, class, socio-economic status, family type, residence,duration of illness, psychiatric diagnosis, treatment availed.
Raven’s Standard Progressive Matrices (RSPM).RSPM, developed by Raven, Court & Raven (1938), is a measure of fluid intelligence. It measures a person’s capacity at the time of the test to apprehend meaningless figures presented for his/her observation, see the relations between them, conceive the nature of the figure completing each system of relations presented, and by doing so, developing a systematic method of reasoning. The scale consists of 60 problems divided into five sets of 12. In each set, the first problem is nearly as self-evident as possible. The problems that follow become progressively more difficult. RSPM was designed to cover the widest possible range of mental ability and to be equally useful with persons of all ages, whatever their nationality, education, or physical conditions. The scores will be converted to IQ scores.
Raven’s Coloured Progressive Matrices (RCPM).RCPM, developed by J. C. Raven (1949), was designed for children aged 5 through 11, the elderly, and mentally and physically impaired individuals. It contains sets A and B from the RSPM, with a further set of 12 items inserted between the two, as set AB. Most items are presented on a coloured background to make the test visually stimulating for participants. The scores will be converted to IQ scores.
Children’s Colour Trail Test (CCTT). Developed by Llorente et al. (2003), it assesses sustained attention, divided attention, sequencing, and speed of mental processing in children between 8to 16 years. The test-retest reliability ranged from r=0.45 to 0.68, alternate form reliability from r=0.85 to 0.90, and concurrent validity from r=0.54 to 0.74. Construct and factorial validity were also established.
Conner’s Parent Rating (IV ed.).Conners Short (4th ed.) is a 53-item tool for the assessment of ADHD and associated symptoms. It is the shorter version of the Conner Full Version. It has a negative impression scale, scales for inattention, hyperactivity, impulsivity and emotional dysregulation, an impairment and functional outcomes scale, and an ADHD index. It can be completed by any parent or guardian of a child between 6-18 years of age. The rating is done on a 4-point Likert scale rating. It takes about 7 minutes to administer. The internal consistency of the test (median omega=0.92) has been established with a low standard error of measurement (SEM). The test-retest reliability was found to be 0.83 to 0.94, and the inter-rater reliability was 0.68 to 0.81 for two parents.
Child and Adolescent Mindfulness Measure (CAMM). Developed by Greco et al. (2011), CAMM is a 10-item scale that measures mindfulness skills, including non-judgmental attitude, current awareness, and responses to thoughts and feelings. It can be administered to adolescents aged 10-17 years. The rating is done along a 5-point Likert scale. The internal consistency (α=0.81) was established. The scale was found to be positively correlated to Youth Quality of Life-Revised (YQL-R; r=0.25) and Academic Competence Scale (ACS; r=0.25, p<0.01), and negatively correlated to Children’s Somatization Inventory-Short Form (r = -0.40), internalizing (r = -0.51) and externalizing (r = -0.36) symptoms (Symptoms and Functioning Scale, SFS).
Clinical Global Impression (CGI).CGI was developed by the National Institute of Mental Health (NIMH), USA (1976). It assesses the patient’s global functioning prior to and after initiating an intervention along a 7-point Likert scale. It has been found to be significantly correlated to MHQ and DASS.
Child Global Assessment Scale (CGAS). CGAS was developed by Shaffer et al. (1983). It is designed to reflect the lowest level of functioning of an individual under 18 years of age during a specified period. Scores range from 0 to 100. The interclass correlation (r=0.84) was established with low SEM. The test-retest reliability ranged from 0.69-0.95.
Kidscreen-27. The Kidscreen-27 (Revens-Sieberer et al., 2007) measures five domains of health-related quality of life (HRQoL), including physical and psychological well-being, autonomy and parent relations, peers and social support, and school environment. It has been standardised for children between 8-18 years. The internal consistency was found to be greater than 0.70 for all the dimensions, and correlations with corresponding scales of Kidscreen-52 ranged from 0.63 to 0.96. The correlations between other HRQoL questionnaires and Kidscreen-27 dimensions were moderate to high for those assessing similar constructs (r=0.36-0.63).
Family Management Measure (FaMM). Developed by Knafl et al. (2011), FaMM measures how families caring for a child with a chronic condition function along six subscales, condition management ability, child’s daily life, condition management effort, family life difficulty, view of condition impact, and parent mutuality. The internal consistency ranged from 0.72 to 0.91, and test-retest reliability ranged from 0.71 to 0.94. FaMM was found to be moderately correlated with established measures of family functioning.
Five Factor Mindfulness Questionnaire (FFMQ). FFMQ was developed by Baer et al. (2006) and is used to measure mindfulness across five domains: observing, describing, acting with awareness, non-judgement, and non-reactivity. It can be used with individuals over 16 years of age. There are 15 items that are rated along a 5-point Likert scale. The internal consistency ranged between 0.75 to 0.91.
Parental Stress Scale (PSS). This scale measures stress associated with caring for a child and was developed by Berry and Jones (1995). It has 18 items and is rated along a 5-point Likert scale. It can be used with adults. The internal consistency ranged between 0.83 to 0.86, and test-retest reliability was 0.81.
Statistical Analysis
Data from the interviews will be analysed through thematic analysis. Data will be checked for normalcy, wherever applicable. Descriptive statistics, including percentages, frequencies, means and standard deviations, will be used to examine the data obtained. Appropriate parametric and non-parametric tests will be used to compare the study group and control group post assessment. All tests will be two-tailed and statistical significance will be set at p<0.05 level for interpretation.
Phase 2: Evaluating the effect of the newly developed intervention
Sample & Randomisation
Sample. At least 40 adolescents and their parents will be equally randomized into two groups based on the inclusion and exclusion criteria discussed above.
Randomisation. The selected sample will be randomised through simple random sampling using computer generated random numbers.
Allocation.1:1 allocation will be done to both study and control groups.
Blinding. The participants will be blinded to the group allocation.
Selection Criteria
Selection criteria for the intervention
Inclusion criteria
Exclusion criteria
Adolescents
Child aged 10-17 years
Clinical diagnosis of ADHD as per DSM-5
Child having an estimated IQ≥80
Willing to give written assent
Not receiving any other psychotherapeutic intervention in the past year
Adolescents
Unable or unwilling to give written assent
Current or past history of gross psychiatric or medical symptoms that would hinder the therapeutic process
History of neurodevelopmental disorders other than ADHD and Specific Learning Disorder (SLD)
Parents
Stay with the child for at least the past one year, and actively involved in the child’s issues
Ability to comprehend instructions
Willing to give informed written consent
Ability to read and write
Willing to attend at least 75% of the sessions
Parents
Unwilling or unable to give informed written consent
Unable to comprehend instructions
More than one person in family having a chronic psychiatric illness
Any known major psychiatric or medical illness that could hinder the delivery of the intervention
PICOT Guidelines
Population
10–17-year-olds with ADHD and their parents
Intervention
Mindfulness-based intervention
Comparator/Control
Behavioural intervention
Outcome Variables
Sustained attention, divided attention, sequencing, and speed of mental processing, symptoms of ADHD and impairments, mindfulness in adolescents and parents, health related quality of life, emotional regulation, impulsiveness, parental stress, family dynamics
Time Points of Assessment
Baseline and post assessment
Tools to be used
Sociodemographic and clinical sheet.Containing information on age, gender, class, socio-economic status, family type, residence,duration of illness, psychiatric diagnosis, treatment availed.
Raven’s Standard Progressive Matrices (RSPM).RSPM, developed by Raven, Court & Raven (1938), is a measure of fluid intelligence. It measures a person’s capacity at the time of the test to apprehend meaningless figures presented for his/her observation, see the relations between them, conceive the nature of the figure completing each system of relations presented, and by doing so, developing a systematic method of reasoning. The scale consists of 60 problems divided into five sets of 12. In each set, the first problem is as self-evident as possible. The problems that follow become progressively more difficult. RSPM was designed to cover the widest possible range of mental ability and to be equally useful with persons of all ages, whatever their nationality, education, or physical conditions. The scores will be converted to IQ scores.
Raven’s Coloured Progressive Matrices (RCPM).RCPM, developed by J. C. Raven (1949), was designed for children aged 5 through 11, the elderly, and mentally and physically impaired individuals. It contains sets A and B from the RSPM, with a further set of 12 items inserted between the two, as set AB. Most items are presented on a coloured background to make the test visually stimulating for participants. The scores will be converted to IQ scores.
Children’s Colour Trail Test (CCTT). Developed by Llorente et al. (2003), it assesses sustained attention, divided attention, sequencing, and speed of mental processing in children between 8 to 16 years. The test-retest reliability ranged from r=0.45 to 0.68, alternate form reliability from r=0.85 to 0.90, and concurrent validity from r=0.54 to 0.74. Construct and factorial validity were also established.
Conner’s Parent Rating (IV ed.).Conners Short (4th ed.) is a 53-item tool for the assessment of ADHD and associated symptoms. It is the shorter version of the Conner Full Version. It has a negative impression scale, scales for inattention, hyperactivity, impulsivity and emotional dysregulation, an impairment and functional outcomes scale, and an ADHD index. It can be completed by any parent or guardian of a child between 6-18 years of age. The rating is done on a 4-point Likert scale rating. It takes about 7 minutes to administer. The internal consistency of the test (median omega=0.92) has been established with a low standard error of measurement (SEM). The test-retest reliability was found to be 0.83 to 0.94, and the inter-rater reliability was 0.68 to 0.81 for two parents.
Child and Adolescent Mindfulness Measure (CAMM). Developed by Greco et al. (2011), CAMM is a 10-item scale that measures mindfulness skills, including non-judgmental attitude, current awareness, and responses to thoughts and feelings. It can be administered to adolescents aged 10-17 years. The rating is done along a 5-point Likert scale. The internal consistency (α=0.81) was established. The scale was found to be positively correlated to Youth Quality of Life-Revised (YQL-R; r=0.25) and Academic Competence Scale (ACS; r=0.25, p<0.01), and negatively correlated to Children’s Somatization Inventory-Short Form (r = -0.40), internalizing (r = -0.51) and externalizing (r = -0.36) symptoms (Symptoms and Functioning Scale, SFS).
Clinical Global Impression (CGI). CGI was developed by the National Institute of Mental Health (NIMH), USA (1976). It assesses the patient’s global functioning prior to and after initiating an intervention along a 7-point Likert scale. It has been found to be significantly correlated to MHQ and DASS.
Child Global Assessment Scale (CGAS). CGAS was developed by Shaffer et al. (1983). It is designed to reflect the lowest level of functioning of an individual under 18 years of age during a specified period. Scores range from 0 to 100. The interclass correlation (r=0.84) was established with low SEM. The test-retest reliability ranged from 0.69-0.95.
Kidscreen-27. The Kidscreen-27 (Revens-Sieberer et al., 2007) measures five domains of health-related quality of life (HRQoL), including physical and psychological well-being, autonomy and parent relations, peers and social support, and school environment. It has been standardized for children between 8-18 years. The internal consistency was found to be greater than 0.70 for all the dimensions, and correlations with corresponding scales of Kidscreen-52 ranged from 0.63 to 0.96. The correlations between other HRQoL questionnaires and Kidscreen-27 dimensions were moderate to high for those assessing similar constructs (r=0.36-0.63).
Family Management Measure (FaMM). Developed by Knafl et al. (2011), FaMM measures how families caring for a child with a chronic condition function along six subscales, condition management ability, child’s daily life, condition management effort, family life difficulty, view of condition impact, and parent mutuality. The internal consistency ranged from 0.72 to 0.91, and test-retest reliability ranged from 0.71 to 0.94. FaMM was found to be moderately correlated with established measures of family functioning.
Five Factor Mindfulness Questionnaire (FFMQ). FFMQ was developed by Baer et al. (2006) and is used to measure mindfulness across five domains: observing, describing, acting with awareness, non-judgement, and non-reactivity. It can be used with individuals over 16 years of age. There are 15 items that are rated along a 5-point Likert scale. The internal consistency ranged between 0.75 to 0.91.
Parental Stress Scale (PSS). This scale measures stress associated with caring for a child and was developed by Berry and Jones (1995). It has 18 items and is rated along a 5-point Likert scale. It can be used with adults. The internal consistency ranged between 0.83 to 0.86, and test-retest reliability was 0.81.
Procedure
Flow chart for Phase 2
Patients visiting the Child and Adolescent Psychiatry Clinic of Psychiatry OPD, AIIMSwill be assessed for eligibility based on the inclusion and exclusion criteria.Informed consent would be taken from the parents of children and assent will be taken from the participants. The children will be screened through either RCPM or RSPM, and if found to have an IQ 80 or above, will be included in the study.Baseline assessment will be conducted for the participants selectedand then they will be randomised into study and control groups based on 1:1 allocation. Each group will receive respective intervention, followed by re-assessment. The study group will receive the newly developed mindfulness-based intervention in groups of 5-6 participants, and the control group will receive a behavioural intervention aimed at both parents and children. Both groups will receive an equivalent number of sessions and the duration of contact between the therapist and each group willbe equivalent. Final analysis will be conducted on the data.
Statistical Analysis
Data from the second phase will be checked for normalcy, wherever applicable. Descriptive statistics, including percentages, frequencies, means and standard deviations, will be used to examine the data obtained. To establish the association between groups, chi square or Fisher’s exact test will be used. Appropriate parametric and non-parametric tests will be used to compare the study group and control group post assessment. All tests will be two-tailed and statistical significance will be set at 0.05 level for interpretation.Data analysis will be done by statistical package SPSS.
Ethical Considerations
Ethical clearance will be obtained from the Institute Ethics Committee.Written informed consent will be obtained from parent/LAR and assent from the adolescents will be taken.Participants will have a right to withdraw any time throughout the study.Their participation or non-participation will not influence the services availed at the OPD. Confidentiality of all participants would be ensured and maintained. CTRI registration will be done.