ADHD Treatment for Latino Families

ADHD Clinical Trial

Official title:

Standard Versus Culturally-Modified ADHD Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02317692
• Other study ID #: HR-2871
• Status: Completed
• Phase: N/A
• First received: December 9, 2014
• Last updated: October 18, 2017
• Start date: January 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2017
• Source: Marquette University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Parent training

Locations

Country	Name	City	State
United States	Marquette University	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Marquette University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment)	Number of families who completed treatment (recorded by clinician)	8 weeks
Primary	Engagement in Treatment - Sessions Attended	Number of sessions attended by each family (recorded by clinician)	8 weeks
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)	8 weeks
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)	8 weeks
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.	Baseline to 8 weeks
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.	8 weeks
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.	8 weeks