Trial Outcomes & Findings for Stage 1 Treatment Development With Homeless Mothers (NCT NCT01193114)

NCT ID: NCT01193114

Last Updated: 2013-03-01

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 3 months post-baseline measure
• Results posted on: 2013-03-01

Participant Flow

Participant milestones

Measure	Ecologically-Based Behavioral Treatment Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.	Treatment as Usual The Mothers were offered services provided through the family shelter.
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stage 1 Treatment Development With Homeless Mothers

Baseline characteristics by cohort

Measure	Ecologically-Based Behavioral Treatment n=30 Participants Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.	Treatment as Usual n=30 Participants The Mothers were offered services provided through the family shelter.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	25.60 years STANDARD_DEVIATION 5.54 • n=5 Participants	27 years STANDARD_DEVIATION 6.46 • n=7 Participants	26.30 years STANDARD_DEVIATION 6.01 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months post-baseline measure

Population: The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.

Outcome measures

Measure	Ecologically-Based Behavioral Treatment n=30 Participants Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.	Treatment as Usual n=24 Participants The Mothers were offered services provided through the family shelter.
Percent Days of Substance Use in the Prior 3 Months.	45.40 percent days of substance use Standard Deviation 38.79	49.17 percent days of substance use Standard Deviation 41.87

PRIMARY outcome

Timeframe: 6 months post-baseline measure

Population: The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.

Outcome measures

Measure	Ecologically-Based Behavioral Treatment n=30 Participants Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.	Treatment as Usual n=23 Participants The Mothers were offered services provided through the family shelter.
Percent Days of Substance Use in the Prior 3 Months.	34.55 percent days of substance use Standard Deviation 39.09	46.84 percent days of substance use Standard Deviation 36.29

PRIMARY outcome

Timeframe: 9 months post-baseline measure

Population: The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.

Outcome measures

Measure	Ecologically-Based Behavioral Treatment n=30 Participants Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.	Treatment as Usual n=24 Participants The Mothers were offered services provided through the family shelter.
Percent Days of Substance Use in the Prior 3 Months.	41.74 percent days of substance use Standard Deviation 38.53	44.54 percent days of substance use Standard Deviation 41.67

SECONDARY outcome

Timeframe: 3 months post-baseline measure

Population: The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.

Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)

Outcome measures

Measure	Ecologically-Based Behavioral Treatment n=30 Participants Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.	Treatment as Usual n=24 Participants The Mothers were offered services provided through the family shelter.
BDI Depression Score	15.03 units on a scale Standard Deviation 15.10	13.63 units on a scale Standard Deviation 10.03

SECONDARY outcome

Timeframe: 6 months post-baseline measure

Population: The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.

Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)

Outcome measures

Measure	Ecologically-Based Behavioral Treatment n=30 Participants Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.	Treatment as Usual n=23 Participants The Mothers were offered services provided through the family shelter.
BDI Depression Score	14.63 units on a scale Standard Deviation 13.67	14.91 units on a scale Standard Deviation 11.17

SECONDARY outcome

Timeframe: 9 months post-baseline measure

Population: The analysis was conducted with all of the collected data. Discrepancies in number of participants between the Participant Flow Module and the analysis are due to missing data.

Beck Depression Inventory - II (BDI - II) Range from 0 (no depression) to 63 (severe depression)

Outcome measures

Measure	Ecologically-Based Behavioral Treatment n=29 Participants Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.	Treatment as Usual n=24 Participants The Mothers were offered services provided through the family shelter.
BDI Depression Score	13.21 units on a scale Standard Deviation 13.46	13.38 units on a scale Standard Deviation 12.06

Adverse Events

Ecologically-Based Behavioral Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

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. Natasha Slesnick

The Ohio State University

Phone: 614 247-8469

Email: slesnick.5@osu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place