Clinical trial NCT02317692: ADHD Treatment for Latino Families
Official title: Standard Versus Culturally-Modified ADHD Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Lead sponsor: Marquette University
Sponsor class: OTHER
First posted: 2014-12-16
Enrollment: 147
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment)
timeFrame: 8 weeks
measure: Engagement in Treatment - Sessions Attended
timeFrame: 8 weeks
measure: Engagement in Treatment - Homework Completion (% of Completed Homework)
timeFrame: 8 weeks
measure: Acceptability of Treatment (Summary Score of Therapy Attitude Inventory)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale)
timeFrame: Baseline to 8 weeks
measure: Change in Parental Functioning (Maternal Parenting Stress)
timeFrame: 8 weeks
measure: Effects of Socioeconomic Status and Parental Acculturation on Treatment Outcomes (Parental Report)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
References: