ADHD
Conditions
Brief summary
The current pilot study aims to close the existing gap in our knowledge about effective psychosocial treatments for Latino families by providing preliminary data regarding the acceptability and efficacy of a culturally-modified ADHD treatment and possible moderators that will support a future R01. Specifically, the current pilot study is the first step in a larger program of research aimed at definitively determining if culturally-modified ADHD treatment outperforms standard treatment when examining engagement and acceptability outcomes, as well as symptomatology and parental functioning, and if so, which treatment modifications are necessary and for whom. The following study aims will be examined. 1. Aim 1 is to explore if the culturally-modified treatment results in better engagement and acceptability outcomes (i.e., parental attendance, retention, engagement, and satisfaction) than standard treatment and to determine the strength of these effects. 2. Aim 2 is to explore if the culturally-modified treatment results in improvements in ADHD symptomatology, as well as parental functioning (i.e., parenting stress and efficacy), to explore if the modified treatment results in similar or greater improvements than standard treatment, and to determine the strength of these effects. 3. Aim 3 is to explore possible moderators (i.e., socioeconomic status (SES) and behavioral and cognitive acculturation) that may explain the relationship between treatment type (i.e., standard versus culturally-modified) and outcomes and to determine the strength of these interactions.
Interventions
BEHAVIORALParent training
Sponsors
Marquette University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
5 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* Children must 1. Self-identify as Latino and be between the ages of 5 and 13 years at the time of the initial assessment 2. Receive a primary diagnosis of ADHD 3. If medicated for ADHD, be on a stable dose of medication for at least two weeks prior to the assessment * Participating parents must 1. Self-identify as Latino 2. Be fluent in Spanish 3. Be able and willing to provide informed consent and comply with the study procedures, including being assigned either to standard or culturally-modified treatment 4. Have no immediate plans to pursue other treatment for their child's ADHD or to change their child's medication (if already medicated) over the next eight weeks
Exclusion criteria
* Children must not meet DSM-5 diagnostic criteria for Intellectual Disability, Autism Spectrum Disorder, or a psychotic disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment) | 8 weeks | Number of families who completed treatment (recorded by clinician) |
| Engagement in Treatment - Sessions Attended | 8 weeks | Number of sessions attended by each family (recorded by clinician) |
| Engagement in Treatment - Homework Completion (% of Completed Homework) | 8 weeks | (recorded by clinician - homework was assigned every week and was expected to be returned at the next week's session) |
| Acceptability of Treatment (Summary Score of Therapy Attitude Inventory) | 8 weeks | Parental report of satisfaction with treatment (summary score of Therapy Attitude Inventory) Range=10-50; higher scores represent greater satisfaction (a better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Parental Functioning (Maternal Parenting Stress) | 8 weeks | Pre-treatment to post-treatment change on summary score of Parenting Stress Index-Short Form (completed by mothers) Range=0-144; the larger the number, the greater stress Difference in mean pre and post scores for each group, so SD was not calculated. |
| Effects of Socioeconomic Status and Parental Acculturation on Treatment Outcomes (Parental Report) | 8 weeks | Socioeconomic status computed based on parental report of education and occupation (assessed on demographic form). Acculturation based on parental report on the Acculturation Rating Scale for Mexican Americans-II and the Mexican American Cultural Values for Adolescents and Adults. |
| Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale) | Baseline to 8 weeks | Pre-treatment to post-treatment change on inattention subscale of Disruptive Behavior Disorders Rating Scale (completed by parent) Range=0-3; the larger the number, the greater the symptoms Difference in mean pre and post scores for each group, so SD was not calculated. |
Countries
United States
Participant flow
Recruitment details
Total number of participants includes children, mothers, and fathers.
Pre-assignment details
1 father did not complete post-treatment measures.
Participants by arm
| Arm | Count |
|---|---|
| Standard ADHD Parent Training 8 sessions of evidence-based parent training plus school intervention
Parent training | 69 |
| Standard ADHD Parent Training 8 sessions of evidence-based parent training plus school intervention
Parent training | 30 |
| Culturally-modified ADHD Parent Training 8 sessions of culturally-modified parent training plus school intervention
Parent training | 77 |
| Culturally-modified ADHD Parent Training 8 sessions of culturally-modified parent training plus school intervention
Parent training | 31 |
| Total | 207 |
Baseline characteristics
| Characteristic | Standard ADHD Parent Training | Culturally-modified ADHD Parent Training | Total |
|---|---|---|---|
| Age, Continuous | 8.13 years | 7.84 years | 7.98 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants | 31 Participants | 61 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 30 Families | 31 Families | 61 Families |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 21 Participants | 23 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 69 | 0 / 77 |
| other Total, other adverse events | 0 / 69 | 0 / 77 |
| serious Total, serious adverse events | 0 / 69 | 0 / 77 |
Outcome results
Primary
Acceptability of Treatment (Summary Score of Therapy Attitude Inventory)
Parental report of satisfaction with treatment (summary score of Therapy Attitude Inventory) Range=10-50; higher scores represent greater satisfaction (a better outcome)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ADHD Parent Training | Acceptability of Treatment (Summary Score of Therapy Attitude Inventory) | 44.74 units on a scale | Standard Deviation 3.57 |
| Culturally-modified ADHD Parent Training | Acceptability of Treatment (Summary Score of Therapy Attitude Inventory) | 46.93 units on a scale | Standard Deviation 3.17 |
Primary
Engagement in Treatment - Homework Completion (% of Completed Homework)
(recorded by clinician - homework was assigned every week and was expected to be returned at the next week's session)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ADHD Parent Training | Engagement in Treatment - Homework Completion (% of Completed Homework) | 68.95 percentage of completed homework | Standard Deviation 24.36 |
| Culturally-modified ADHD Parent Training | Engagement in Treatment - Homework Completion (% of Completed Homework) | 88.83 percentage of completed homework | Standard Deviation 13.63 |
Primary
Engagement in Treatment - Sessions Attended
Number of sessions attended by each family (recorded by clinician)
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard ADHD Parent Training | Engagement in Treatment - Sessions Attended | 6.93 sessions | Standard Deviation 1.46 |
| Culturally-modified ADHD Parent Training | Engagement in Treatment - Sessions Attended | 7.52 sessions | Standard Deviation 0.93 |
Primary
Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment)
Number of families who completed treatment (recorded by clinician)
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Standard ADHD Parent Training | Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment) | 27 Families |
| Culturally-modified ADHD Parent Training | Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment) | 31 Families |
Secondary
Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale)
Pre-treatment to post-treatment change on inattention subscale of Disruptive Behavior Disorders Rating Scale (completed by parent) Range=0-3; the larger the number, the greater the symptoms Difference in mean pre and post scores for each group, so SD was not calculated.
Time frame: Baseline to 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard ADHD Parent Training | Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale) | -.14 units on a scale |
| Culturally-modified ADHD Parent Training | Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale) | -.44 units on a scale |
Secondary
Change in Parental Functioning (Maternal Parenting Stress)
Pre-treatment to post-treatment change on summary score of Parenting Stress Index-Short Form (completed by mothers) Range=0-144; the larger the number, the greater stress Difference in mean pre and post scores for each group, so SD was not calculated.
Time frame: 8 weeks
Population: Only mothers completed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard ADHD Parent Training | Change in Parental Functioning (Maternal Parenting Stress) | -7.22 units on a scale |
| Culturally-modified ADHD Parent Training | Change in Parental Functioning (Maternal Parenting Stress) | -11.1 units on a scale |
Secondary
Effects of Socioeconomic Status and Parental Acculturation on Treatment Outcomes (Parental Report)
Socioeconomic status computed based on parental report of education and occupation (assessed on demographic form). Acculturation based on parental report on the Acculturation Rating Scale for Mexican Americans-II and the Mexican American Cultural Values for Adolescents and Adults.
Time frame: 8 weeks
Population: We did not examine this outcome measure due to a lack of variability on the SES and acculturation measure.