Development of a mindfulness-based intervention for adolescents with ADHD

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

1. To develop a mindfulness-based intervention module for symptom improvement in adolescents with ADHD and their parents, and assess its feasibility

2. To evaluate the effect of the newly developed mindfulness-based intervention

Research Questions

1. Will a group mindfulness-based intervention be feasible to deliver to children with ADHD and their parents in Indian culture?

2. What will be the effect of the newly developed mindfulness-based intervention?

Hypotheses

1. The group mindfulness-based intervention will not be feasible in adolescents with ADHD and their parents.

2. 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

 

Steps for phase 1

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.

2. 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

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• Mental health practitioners using mindfulness-based interventions with patients in India

• Dealing with a child and adolescent clinical population

• With at least 2 years of experience

• Not willing to consent

3. 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.

4. 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)

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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

1. Sociodemographic and clinical sheet. Containing information on age, gender, class, socio-economic status, family type, residence, duration of illness, psychiatric diagnosis, treatment availed.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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).

7. 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.

8. 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.

9. 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).

10. 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.

11. 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.

12. 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

1. Sample. At least 40 adolescents and their parents will be equally randomized into two groups based on the inclusion and exclusion criteria discussed above.

2. Randomisation. The selected sample will be randomised through simple random sampling using computer generated random numbers.

3. Allocation. 1:1 allocation will be done to both study and control groups.

4. 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

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Intervention

Mindfulness-based intervention

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Comparator/Control

Behavioural intervention

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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

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Time Points of Assessment

Baseline and post assessment

Tools to be used

1. Sociodemographic and clinical sheet. Containing information on age, gender, class, socio-economic status, family type, residence, duration of illness, psychiatric diagnosis, treatment availed.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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).

7. 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.

8. 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.

9. 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).

10. 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.

11. 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.

12. 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, AIIMS will 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 selected and 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 will be 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.