ADHDNCT02317692
ADHD Treatment for Latino Families
A study testing Parent training in people with ADHD, run by Marquette University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- ADHD
- What is being tested?
- Parent training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children must
- Self-identify as Latino and be between the ages of 5 and 13 years at the time of the initial assessment
- Receive a primary diagnosis of ADHD
- If medicated for ADHD, be on a stable dose of medication for at least two weeks prior to the assessment
- Participating parents must
- Self-identify as Latino
Show all 9Show fewer
- Be fluent in Spanish
- Be able and willing to provide informed consent and comply with the study procedures, including being assigned either to standard or culturally-modified treatment
- 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
Who cannot join
- Children must not meet DSM-5 diagnostic criteria for Intellectual Disability, Autism Spectrum Disorder, or a psychotic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Standard Versus Culturally-Modified ADHD Treatment
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.
- 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.
- 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.
- 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.
- Conditions
- ADHD
- Being tested
- Parent training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Standard ADHD parent training | Active comparator | 8 sessions of evidence-based parent training plus school intervention Receives: Behavioral: Parent training |
| Culturally-modified ADHD parent training | Experimental | 8 sessions of culturally-modified parent training plus school intervention Receives: Behavioral: Parent training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment)
Number of families who completed treatment (recorded by clinician)
Measured: 8 weeks
Engagement in Treatment - Sessions Attended
Number of sessions attended by each family (recorded by clinician)
Measured: 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)
Measured: 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)
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: Baseline to 8 weeks
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alyson Gerdes, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317692
- Sponsor's protocol ID
- HR-2871
- Status last verified
- May 2017
- First submitted
- 9 Dec 2014
- Last updated
- 23 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Culturally-Modified ADHD Treatment
- ClinicalTrials.gov ID
- NCT02317692
- Acronym / sponsor ID
- HR-2871
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 16 Dec 2014 (estimated)
- Results
- Posted 23 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard ADHD parent training | Active comparator | Behavioral: Parent training8 sessions of evidence-based parent training plus school intervention |
| Culturally-modified ADHD parent training | Experimental | Behavioral: Parent training8 sessions of culturally-modified parent training plus school intervention |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Children must
- Participating parents must
Key exclusion criteria (1 listed)
- Children must not meet DSM-5 diagnostic criteria for Intellectual Disability, Autism Spectrum Disorder, or a psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent training | Behavioural | Culturally-modified ADHD parent training, Standard ADHD parent training |
Primary outcome
Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment)
Time frame: 8 weeks
Number of families who completed treatment (recorded by clinician)
Engagement in Treatment - Sessions Attended
Time frame: 8 weeks
Number of sessions attended by each family (recorded by clinician)
Engagement in Treatment - Homework Completion (% of Completed Homework)
Time frame: 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)
Time frame: 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)
3 secondary outcomes
Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale)
Time frame: Baseline to 8 weeks
Change in Parental Functioning (Maternal Parenting Stress)
Time frame: 8 weeks
Effects of Socioeconomic Status and Parental Acculturation on Treatment Outcomes (Parental Report)
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent training in people with ADHD, run by Marquette University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.