ADHD
Conditions
Keywords
shared decision making
Brief summary
This is a retrospective observational survey study. We will survey a sample of adult parents or legal guardians who have a child who has been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and who discussed ADHD treatment options for their child with a health care provider within the last 2 years. The main goal is to gather evidence of the validity and reliability of the Shared Decision Making Process scale. Secondary goal is to gather evidence on the quality of decisions parents make about their children with ADHD. A third goal is to assess the impact of a Decision Aid on participant knowledge of ADHD treatment options. Participants will be randomized to one of two arms: participants in the intervention arm will review a Decision Aid (patient educational tool) partway through the survey and those in the control arm will not receive any educational materials. All participants will complete survey that includes the Shared Decision Making process survey along with a few other measures. A subset of respondents will also complete a retest survey about two weeks after the initial survey.
Detailed description
This is a retrospective observational survey study. We will survey a sample of adult parents or legal guardians who have a child who has been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) and who discussed ADHD treatment options for their child with a health care provider within the last 2 years. The main goal is to gather evidence of the validity and reliability of the Shared Decision Making Process scale. Secondary goal is to gather evidence on the quality of decisions parents make about their children with ADHD. A third goal is to assess the impact of a Decision Aid on participant knowledge of ADHD treatment options. Participants will be randomized to one of two arms: participants in the intervention arm will review a Decision Aid (patient educational tool) partway through the survey and those in the control arm will not receive any educational materials. All participants will complete survey that includes the Shared Decision Making process survey along with a few other measures. A subset of respondents will also complete a retest survey about two weeks after the initial survey. Study staff are working with a national sampling firm to recruit subjects and obtain 500 responses. The sample size was determined to ensure 80% power to detect difference of 0.25SD at 0.05 significant between intervention and control arm on participant knowledge scores. The decision aid intervention consists of a set of pre-visit summary cards for parents that cover the different treatment options and was developed by the Cincinnati Children's Hospital Medical Center. For the analyses, study staff will examine the descriptives of the Shared Decision Making Process items and knowledge scores for the two arms. Study staff will examine rates of missing data to determine acceptability, and will examine descriptive results to see whether the scores span the range of total possible scores, are normally distributed, and whether there is evidence of floor or ceiling effects. Study staff will also test several hypotheses to examine validity of the scores such as whether higher shared decision making process scores are associated with less decisional conflict and less regret. Staff will also examine retest reliability of the Shared Decision Making Process scale.
Interventions
BEHAVIORALAttention Deficit Hyperactivity Disorder Treatment Decision Aid
The parent pre-visit cards from the Cincinnati Children's Hospital's Attention Deficit Hyperactivity Disorder (ADHD) Treatment for School Age Children Decision Aid were used in this study. The 6 pre-visit cards provide an overview of ADHD treatment options, the respective benefits and downsides of each option, and questions to elicit goals/preferences. The four different treatment options presented were: (1) watchful waiting, (2) behavioral treatment, (3) medication treatment, and (4) combined treatment (behavioral and medication together).
Sponsors
University of Massachusetts, Boston
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult parent or legal guardian of a child between the ages of 5 and 13 who has been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) * Read English * Have talked with a health care provider about medication for treatment of ADHD for the child in the past 2 years
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making Process Score | baseline survey (reflecting on the last 24 months) | The Shared Decision Making Process scale is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADHD Knowledge | baseline survey | Multiple choice knowledge items are scored correct/incorrect and a total knowledge score (0-100%) is calculated with higher scores indicating higher knowledge. |
| Decisional Conflict Tool (SURE) | baseline survey | Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates extremely high decisional conflict, 4 indicates no decisional conflict. The number who get score of 4 is reported indicating no decisional conflict. This reports number of participants were reported no decision conflict. |
| Single-item Measure of Decision Regret | baseline survey | Single item asking If you knew then what you know now, do you think you would make the same decision. Response options are: Definitely yes, Probably yes, Probably no, Definitely no. |
| National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Performance Sub-scale | baseline survey | 8 items that ask parents to rate their child's performance in school overall, in individual subjects such as reading, relationships with others such as parents and peers, and their participation in organized activities. There were 5 response options: Excellent, above average, average, somewhat of a problem, and problematic. Total scores range from 8 to 40 with higher scores indicating more problematic behavior |
| Adapted Controlled Preference Scale | baseline survey | Single item asking the parent who made the ultimate decision. The categorical response options are 1) the parent made the decision, 2)the child's provider made the decision, 3) both parent and provider made the decision together, or 4) the decision as made by someone else |
| Shared Decision Making Process Measure Retest | 2 weeks after completing the baseline survey | The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred. |
| Treatment Choice | baseline survey | 1 item that asked parents if their child is currently taking medication to treat their ADHD. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adherence | baseline survey | 1 item measure of adherence to medication for sample of participants who indicated their child was taking medicine. The question asked in the last 30 days, how often did your child take their ADHD medicine in the way they were supposed to? |
Countries
United States
Participant flow
Recruitment details
Eligible participants were recruited through a national sampling firm, but the sample itself was not a national probability sample. The survey was administered between February 2021 and March 2021. A subset of participants were invited to complete a brief follow-up survey to examine short term test-retest reliability.
Pre-assignment details
Eligible participants were caregivers who self-identified as having at least one child between the ages of 5 and 13 years old with ADHD and who had talked with a health care provider about starting, stopping, or changing an ADHD medicine in the last 2 years.
Participants by arm
| Arm | Count |
|---|---|
| Decision Aid Arm Participants in this arm will review educational material from the ADHD Decision Aid developed by the Cincinnati Children's Hospital Medical Center.
Attention Deficit Hyperactivity Disorder Treatment Decision Aid: The parent pre-visit cards from the Cincinnati Children's Hospital's Attention Deficit Hyperactivity Disorder (ADHD) Treatment for School Age Children Decision Aid were used in this study. The 6 pre-visit cards provide an overview of ADHD treatment options, the respective benefits and downsides of each option, and questions to elicit goals/preferences. The four different treatment options presented were: (1) watchful waiting, (2) behavioral treatment, (3) medication treatment, and (4) combined treatment (behavioral and medication together). | 242 |
| Control Arm Participants in this group will not receive any educational materials. | 256 |
| Total | 498 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | did not have sufficient information to calculate the SDM Process score (primary outcome) | 1 | 4 |
| Overall Study | inconsistent answers for main decision for adhd treatment | 9 | 0 |
Baseline characteristics
| Characteristic | Total | Decision Aid Arm | Control Arm |
|---|---|---|---|
| Age, Continuous | 37.6 years STANDARD_DEVIATION 5.5 | 37.7 years STANDARD_DEVIATION 5.2 | 37.5 years STANDARD_DEVIATION 5.8 |
| Race/Ethnicity, Customized American Indian | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 20 Participants | 7 Participants | 13 Participants |
| Race/Ethnicity, Customized Black | 64 Participants | 30 Participants | 34 Participants |
| Race/Ethnicity, Customized Hispanic Only | 39 Participants | 20 Participants | 19 Participants |
| Race/Ethnicity, Customized Multiple Races | 18 Participants | 10 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 9 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 7 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized White, non Hispanic | 337 Participants | 168 Participants | 169 Participants |
| Region of Enrollment United States | 498 participants | 242 participants | 256 participants |
| Sex/Gender, Customized Female | 338 Participants | 166 Participants | 172 Participants |
| Sex/Gender, Customized Male | 159 Participants | 75 Participants | 84 Participants |
| Sex/Gender, Customized Unknown | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 242 | 0 / 256 |
| other Total, other adverse events | 0 / 242 | 0 / 256 |
| serious Total, serious adverse events | 0 / 242 | 0 / 256 |
Outcome results
Primary
Shared Decision Making Process Score
The Shared Decision Making Process scale is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.
Time frame: baseline survey (reflecting on the last 24 months)
Population: participants who provided enough information to calculate a shared decision making process score (primary outcome of interest). 498/498 patients provided an answer to this question.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid Arm | Shared Decision Making Process Score | 2.83 units on a scale | Standard Deviation 1.06 |
| Control Arm | Shared Decision Making Process Score | 2.77 units on a scale | Standard Deviation 1.04 |
Comparison: we tested to see whether SDM Process scores were different between patients who received the Decision Aid Arm vs the control armp-value: 0.50395% CI: [-0.116, 0.236]t-test, 2 sided
Secondary
Adapted Controlled Preference Scale
Single item asking the parent who made the ultimate decision. The categorical response options are 1) the parent made the decision, 2)the child's provider made the decision, 3) both parent and provider made the decision together, or 4) the decision as made by someone else
Time frame: baseline survey
Population: Participants who answered the single-item question. Only 497/498 participants provided sufficient information.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decision Aid Arm | Adapted Controlled Preference Scale | Mainly you | 109 Participants |
| Decision Aid Arm | Adapted Controlled Preference Scale | Mainly your child's healthcare provider | 22 Participants |
| Decision Aid Arm | Adapted Controlled Preference Scale | You and the provider made the decision together | 108 Participants |
| Decision Aid Arm | Adapted Controlled Preference Scale | Mainly someone else | 2 Participants |
| Control Arm | Adapted Controlled Preference Scale | Mainly someone else | 0 Participants |
| Control Arm | Adapted Controlled Preference Scale | Mainly you | 119 Participants |
| Control Arm | Adapted Controlled Preference Scale | You and the provider made the decision together | 110 Participants |
| Control Arm | Adapted Controlled Preference Scale | Mainly your child's healthcare provider | 27 Participants |
Secondary
ADHD Knowledge
Multiple choice knowledge items are scored correct/incorrect and a total knowledge score (0-100%) is calculated with higher scores indicating higher knowledge.
Time frame: baseline survey
Population: participants who completed at least 60% of the knowledge questions. Only 478/498 participants provided sufficient information to calculate a knowledge score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid Arm | ADHD Knowledge | 68.37 percentage of correct answers | Standard Deviation 22.85 |
| Control Arm | ADHD Knowledge | 59.9 percentage of correct answers | Standard Deviation 18.99 |
Secondary
Decisional Conflict Tool (SURE)
Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates extremely high decisional conflict, 4 indicates no decisional conflict. The number who get score of 4 is reported indicating no decisional conflict. This reports number of participants were reported no decision conflict.
Time frame: baseline survey
Population: participants who answered all 4 items of the decisional conflict scale. Only 485/498 provided sufficient information to calculate a SURE score.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Decision Aid Arm | Decisional Conflict Tool (SURE) | 164 Participants |
| Control Arm | Decisional Conflict Tool (SURE) | 184 Participants |
Secondary
National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Performance Sub-scale
8 items that ask parents to rate their child's performance in school overall, in individual subjects such as reading, relationships with others such as parents and peers, and their participation in organized activities. There were 5 response options: Excellent, above average, average, somewhat of a problem, and problematic. Total scores range from 8 to 40 with higher scores indicating more problematic behavior
Time frame: baseline survey
Population: Participants provided sufficient information to calculate a total score. Only 483/498 participants provided sufficient information
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid Arm | National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Performance Sub-scale | 22.46 score on a scale | Standard Deviation 6.38 |
| Control Arm | National Initiative for Children's Healthcare Quality (NICHQ) Vanderbilt Assessment Performance Sub-scale | 21.07 score on a scale | Standard Deviation 6.26 |
Secondary
Shared Decision Making Process Measure Retest
The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.
Time frame: 2 weeks after completing the baseline survey
Population: A subset of participants who completed the baseline survey were re-contacted approximately 2 weeks post baseline survey for a retest. Participants who completed the retest survey and provided enough information to calculate the shared decision making process score were part of this analysis. 208/215 provided both consistent and sufficient information.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Decision Aid Arm | Shared Decision Making Process Measure Retest | 2.84 score on a scale | Standard Deviation 1.01 |
| Control Arm | Shared Decision Making Process Measure Retest | 2.60 score on a scale | Standard Deviation 1.02 |
Secondary
Single-item Measure of Decision Regret
Single item asking If you knew then what you know now, do you think you would make the same decision. Response options are: Definitely yes, Probably yes, Probably no, Definitely no.
Time frame: baseline survey
Population: Participants who answered the single-item regret question. Only 497/498 participants provided sufficient information to calculate regret.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decision Aid Arm | Single-item Measure of Decision Regret | Definitely Yes | 100 Participants |
| Decision Aid Arm | Single-item Measure of Decision Regret | Probably Yes | 116 Participants |
| Decision Aid Arm | Single-item Measure of Decision Regret | Probably No | 18 Participants |
| Decision Aid Arm | Single-item Measure of Decision Regret | Definitely No | 8 Participants |
| Control Arm | Single-item Measure of Decision Regret | Definitely No | 5 Participants |
| Control Arm | Single-item Measure of Decision Regret | Definitely Yes | 102 Participants |
| Control Arm | Single-item Measure of Decision Regret | Probably No | 25 Participants |
| Control Arm | Single-item Measure of Decision Regret | Probably Yes | 123 Participants |
Secondary
Treatment Choice
1 item that asked parents if their child is currently taking medication to treat their ADHD.
Time frame: baseline survey
Population: Participants who answered the question. All 498 participants provided sufficient information for treatment choice.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decision Aid Arm | Treatment Choice | taking medication | 151 Participants |
| Decision Aid Arm | Treatment Choice | not taking medication | 91 Participants |
| Control Arm | Treatment Choice | taking medication | 146 Participants |
| Control Arm | Treatment Choice | not taking medication | 110 Participants |
Other Pre-specified
Adherence
1 item measure of adherence to medication for sample of participants who indicated their child was taking medicine. The question asked in the last 30 days, how often did your child take their ADHD medicine in the way they were supposed to?
Time frame: baseline survey
Population: only parents who stated their child was currently taking medicine was included in this analysis. 297 parents said their child was taking medicine, and 290/297 provided information on adherence
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Decision Aid Arm | Adherence | Never | 5 Participants |
| Decision Aid Arm | Adherence | Rarely | 8 Participants |
| Decision Aid Arm | Adherence | Sometimes | 21 Participants |
| Decision Aid Arm | Adherence | Usually | 16 Participants |
| Decision Aid Arm | Adherence | Almost Always | 30 Participants |
| Decision Aid Arm | Adherence | Always | 69 Participants |
| Control Arm | Adherence | Almost Always | 34 Participants |
| Control Arm | Adherence | Never | 5 Participants |
| Control Arm | Adherence | Usually | 16 Participants |
| Control Arm | Adherence | Rarely | 8 Participants |
| Control Arm | Adherence | Always | 61 Participants |
| Control Arm | Adherence | Sometimes | 17 Participants |