Trial Outcomes & Findings for ADHD Treatment for Latino Families (NCT NCT02317692)

Results Overview

Number of families who completed treatment (recorded by clinician)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

147 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-10-23

Participant Flow

Total number of participants includes children, mothers, and fathers.

1 father did not complete post-treatment measures.

Unit of analysis: Families

Participant milestones

Participant milestones
Measure	Standard ADHD Parent Training 8 sessions of evidence-based parent training plus school intervention Parent training	Culturally-modified ADHD Parent Training 8 sessions of culturally-modified parent training plus school intervention Parent training
Overall Study STARTED	69 30	77 31
Overall Study COMPLETED	63 27	77 31
Overall Study NOT COMPLETED	6 3	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data on age were only collected for children.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard ADHD Parent Training n=69 Participants 8 sessions of evidence-based parent training plus school intervention Parent training	Culturally-modified ADHD Parent Training n=31 Families 8 sessions of culturally-modified parent training plus school intervention Parent training	Total n=61 Families Total of all reporting groups
Age, Continuous	8.13 years n=30 Participants • Data on age were only collected for children.	7.84 years n=31 Participants • Data on age were only collected for children.	7.98 years n=61 Participants • Data on age were only collected for children.
Sex: Female, Male Female	9 Participants n=30 Participants • Only includes data from children.	8 Participants n=31 Participants • Only includes data from children.	17 Participants n=61 Participants • Only includes data from children.
Sex: Female, Male Male	21 Participants n=30 Participants • Only includes data from children.	23 Participants n=31 Participants • Only includes data from children.	44 Participants n=61 Participants • Only includes data from children.
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=30 Participants • Data only represents children.	31 Participants n=31 Participants • Data only represents children.	61 Participants n=61 Participants • Data only represents children.
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=30 Participants • Data only represents children.	0 Participants n=31 Participants • Data only represents children.	0 Participants n=61 Participants • Data only represents children.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants • Data only represents children.	0 Participants n=31 Participants • Data only represents children.	0 Participants n=61 Participants • Data only represents children.
Region of Enrollment United States	30 Families n=30 Families	31 Families n=31 Families	61 Families n=61 Families

PRIMARY outcome

Timeframe: 8 weeks

Number of families who completed treatment (recorded by clinician)

Outcome measures

Outcome measures
Measure	Standard ADHD Parent Training n=30 Families 8 sessions of evidence-based parent training plus school intervention Parent training	Culturally-modified ADHD Parent Training n=31 Families 8 sessions of culturally-modified parent training plus school intervention Parent training
Engagement in Treatment - Treatment Completion (Number of Families Who Completed Treatment)	27 Families	31 Families

PRIMARY outcome

Timeframe: 8 weeks

Number of sessions attended by each family (recorded by clinician)

Outcome measures

Outcome measures
Measure	Standard ADHD Parent Training n=30 Families 8 sessions of evidence-based parent training plus school intervention Parent training	Culturally-modified ADHD Parent Training n=31 Families 8 sessions of culturally-modified parent training plus school intervention Parent training
Engagement in Treatment - Sessions Attended	6.93 sessions Standard Deviation 1.46	7.52 sessions Standard Deviation .93

PRIMARY outcome

Timeframe: 8 weeks

(recorded by clinician - homework was assigned every week and was expected to be returned at the next week's session)

Outcome measures

Outcome measures
Measure	Standard ADHD Parent Training n=30 Families 8 sessions of evidence-based parent training plus school intervention Parent training	Culturally-modified ADHD Parent Training n=31 Families 8 sessions of culturally-modified parent training plus school intervention Parent training
Engagement in Treatment - Homework Completion (% of Completed Homework)	68.95 percentage of completed homework Standard Deviation 24.36	88.83 percentage of completed homework Standard Deviation 13.63

PRIMARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	Standard ADHD Parent Training n=27 Families 8 sessions of evidence-based parent training plus school intervention Parent training	Culturally-modified ADHD Parent Training n=31 Families 8 sessions of culturally-modified parent training plus school intervention Parent training
Acceptability of Treatment (Summary Score of Therapy Attitude Inventory)	44.74 units on a scale Standard Deviation 3.57	46.93 units on a scale Standard Deviation 3.17

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Standard ADHD Parent Training n=27 Families 8 sessions of evidence-based parent training plus school intervention Parent training	Culturally-modified ADHD Parent Training n=31 Families 8 sessions of culturally-modified parent training plus school intervention Parent training
Change in ADHD Symptoms (Inattention Subscale of Disruptive Behavior Disorders Rating Scale)	-.14 units on a scale	-.44 units on a scale

SECONDARY outcome

Timeframe: 8 weeks

Population: Only mothers completed.

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.

Outcome measures

Outcome measures
Measure	Standard ADHD Parent Training n=27 Families 8 sessions of evidence-based parent training plus school intervention Parent training	Culturally-modified ADHD Parent Training n=30 Families 8 sessions of culturally-modified parent training plus school intervention Parent training
Change in Parental Functioning (Maternal Parenting Stress)	-7.22 units on a scale	-11.1 units on a scale

SECONDARY outcome

Timeframe: 8 weeks

Population: We did not examine this outcome measure due to a lack of variability on the SES and acculturation measure.

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.

Outcome measures

Outcome data not reported

Adverse Events

Standard ADHD Parent Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Culturally-modified ADHD Parent Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alyson Gerdes

Marquette University

Phone: 414-288-6145

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place