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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard ADHD parent training | Active Comparator | 8 sessions of evidence-based parent training plus school intervention |
|
| Culturally-modified ADHD parent training | Experimental | 8 sessions of culturally-modified parent training plus school intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent training | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment) | Number of families who completed treatment (recorded by clinician) | 8 weeks |
| Engagement in Treatment - Sessions Attended | Number of sessions attended by each family (recorded by clinician) | 8 weeks |
| 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) | 8 weeks |
| 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) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 8 weeks |
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Inclusion Criteria:
Children must
Participating parents must
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marquette University | Milwaukee | Wisconsin | 53233 | United States |
1 father did not complete post-treatment measures.
Total number of participants includes children, mothers, and fathers.
| ID | Title | Description |
|---|---|---|
| FG000 | Standard ADHD Parent Training | 8 sessions of evidence-based parent training plus school intervention Parent training |
| FG001 | Culturally-modified ADHD Parent Training | 8 sessions of culturally-modified parent training plus school intervention Parent training |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard ADHD Parent Training | 8 sessions of evidence-based parent training plus school intervention Parent training |
| BG001 | Culturally-modified ADHD Parent Training | 8 sessions of culturally-modified parent training plus school intervention Parent training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data on age were only collected for children. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment) | Number of families who completed treatment (recorded by clinician) | Posted | Count of Units | Families | 8 weeks | Families | Families |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard ADHD Parent Training | 8 sessions of evidence-based parent training plus school intervention Parent training |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alyson Gerdes | Marquette University | 414-288-6145 | alyson.gerdes@mu.edu |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| 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. | 8 weeks |
| 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. | 8 weeks |
| BG002 | Total | Total of all reporting groups |
| Families |
|
| Mean |
| Full Range |
| years |
| Participants |
|
|
| Sex: Female, Male | Only includes data from children. | Count of Participants | Participants | Participants |
|
|
| Ethnicity (NIH/OMB) | Data only represents children. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | Families | Families |
|
|
| Units | Counts |
|---|
| Participants |
|
| Families |
|
|
| Primary | Engagement in Treatment - Sessions Attended | Number of sessions attended by each family (recorded by clinician) | Posted | Mean | Standard Deviation | sessions | 8 weeks | Families | Families |
|
|
|
| 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) | Posted | Mean | Standard Deviation | percentage of completed homework | 8 weeks | Families | Families |
|
|
|
| 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) | Posted | Mean | Standard Deviation | units on a scale | 8 weeks | Families | 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. | Posted | Number | units on a scale | Baseline to 8 weeks | Families | Families |
|
|
|
| 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. | Only mothers completed. | Posted | Number | units on a scale | 8 weeks | Families | Families |
|
|
|
| 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. | We did not examine this outcome measure due to a lack of variability on the SES and acculturation measure. | Posted | 8 weeks |
|
|
| 0 |
| 69 |
| 0 |
| 69 |
| 0 |
| 69 |
| EG001 | Culturally-modified ADHD Parent Training | 8 sessions of culturally-modified parent training plus school intervention Parent training | 0 | 77 | 0 | 77 | 0 | 77 |
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| Unknown or Not Reported |
|