Trial Outcomes & Findings for New Haven MOMS Partnership (NCT NCT01665872)

Last Updated: 2020-02-10

Results Overview

Self-report questionnaire which measure attitudes toward seeking mental health treatment. This is defined by looking at total number of outpatient mental health or substance abuse treatment visits in the past year.

Recruitment status

COMPLETED

Study phase

Target enrollment

154 participants

Primary outcome timeframe

1 year

Results posted on

2020-02-10

Participant Flow

Participants were screened throughout the community with a needs assessment during the time frame 05/21/2012 through 06/02/2016.

Participant milestones

Participant milestones
Measure	Cognitive-Behavioral Group Therapy 8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT. Intervention co-facilitated by mental health clinician and a Community Mental Health Ambassador (peer). Cognitive-Behavioral Group Therapy: CBT Group	Standard of Care - Cognitive-Behavioral Group Therapy 8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT. Intervention administered by mental health clinician. Cognitive-Behavioral Group Therapy: CBT Group
Screening STARTED	172	172
Screening COMPLETED	172	172
Screening NOT COMPLETED	0	0
Treatment STARTED	87	67
Treatment COMPLETED	72	50
Treatment NOT COMPLETED	15	17
6 Month Follow-up STARTED	72	50
6 Month Follow-up COMPLETED	66	49
6 Month Follow-up NOT COMPLETED	6	1
12 Month Follow-up STARTED	72	50
12 Month Follow-up COMPLETED	58	47
12 Month Follow-up NOT COMPLETED	14	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

We did not have a response from 3 participants in the Cognitive-Behavioral Group Therapy group

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive-Behavioral Group Therapy n=87 Participants Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador	Standard of Care - Cognitive-Behavioral Group Therapy n=67 Participants Stress Management Class delivered in public housing sites by only a clinician	Total n=154 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=87 Participants	0 Participants n=67 Participants	0 Participants n=154 Participants
Age, Categorical Between 18 and 65 years	87 Participants n=87 Participants	67 Participants n=67 Participants	154 Participants n=154 Participants
Age, Categorical >=65 years	0 Participants n=87 Participants	0 Participants n=67 Participants	0 Participants n=154 Participants
Age, Continuous	38.1 years STANDARD_DEVIATION 11.0 • n=87 Participants	39.2 years STANDARD_DEVIATION 11.2 • n=67 Participants	38.6 years STANDARD_DEVIATION 11.1 • n=154 Participants
Sex: Female, Male Female	87 Participants n=87 Participants	67 Participants n=67 Participants	154 Participants n=154 Participants
Sex: Female, Male Male	0 Participants n=87 Participants	0 Participants n=67 Participants	0 Participants n=154 Participants
Race/Ethnicity, Customized Race / Ethnicity · White, Non-Hispanic	3 Participants n=87 Participants	5 Participants n=67 Participants	8 Participants n=154 Participants
Race/Ethnicity, Customized Race / Ethnicity · Black, Non-Hispanic	68 Participants n=87 Participants	52 Participants n=67 Participants	120 Participants n=154 Participants
Race/Ethnicity, Customized Race / Ethnicity · White, Hispanic	11 Participants n=87 Participants	6 Participants n=67 Participants	17 Participants n=154 Participants
Race/Ethnicity, Customized Race / Ethnicity · Black, Hispanic	2 Participants n=87 Participants	3 Participants n=67 Participants	5 Participants n=154 Participants
Race/Ethnicity, Customized Race / Ethnicity · Other	3 Participants n=87 Participants	1 Participants n=67 Participants	4 Participants n=154 Participants
Region of Enrollment United States	87 participants n=87 Participants	67 participants n=67 Participants	154 participants n=154 Participants
CES-D total score	28.2 units on a scale STANDARD_DEVIATION 9.3 • n=87 Participants	30.4 units on a scale STANDARD_DEVIATION 9.8 • n=67 Participants	29.2 units on a scale STANDARD_DEVIATION 9.6 • n=154 Participants
Total outpatient mental health or substance abuse visits	4.5 visits STANDARD_DEVIATION 16.3 • n=84 Participants • We did not have a response from 3 participants in the Cognitive-Behavioral Group Therapy group	2.1 visits STANDARD_DEVIATION 10.0 • n=67 Participants • We did not have a response from 3 participants in the Cognitive-Behavioral Group Therapy group	3.4 visits STANDARD_DEVIATION 13.9 • n=151 Participants • We did not have a response from 3 participants in the Cognitive-Behavioral Group Therapy group
Parenting Stress Index Short Form: Parental Distress Percentile	82.4 percentile STANDARD_DEVIATION 21.2 • n=47 Participants • This measure was only collected on participants whose youngest child was 7 years or younger.	73.9 percentile STANDARD_DEVIATION 28.5 • n=34 Participants • This measure was only collected on participants whose youngest child was 7 years or younger.	78.9 percentile STANDARD_DEVIATION 24.7 • n=81 Participants • This measure was only collected on participants whose youngest child was 7 years or younger.
Parenting Stress Index: Parent-Child Dysfunctional Interaction Percentile	61.4 percentile STANDARD_DEVIATION 30.0 • n=47 Participants • This measure was only collected on participants whose youngest child was 7 years or younger.	59.6 percentile STANDARD_DEVIATION 33.3 • n=34 Participants • This measure was only collected on participants whose youngest child was 7 years or younger.	60.7 percentile STANDARD_DEVIATION 31.2 • n=81 Participants • This measure was only collected on participants whose youngest child was 7 years or younger.
Parenting Stress Index: Difficult Child Percentile	62.0 percentile STANDARD_DEVIATION 33.6 • n=47 Participants • This measure was only collected on participants whose youngest child was 7 years or younger.	58.9 percentile STANDARD_DEVIATION 31.4 • n=34 Participants • This measure was only collected on participants whose youngest child was 7 years or younger.	60.7 percentile STANDARD_DEVIATION 32.5 • n=81 Participants • This measure was only collected on participants whose youngest child was 7 years or younger.
Parenting Stress Index Short Form: Total Score Percentile	75.8 percentile STANDARD_DEVIATION 27.6 • n=47 Participants • This measure was only collected on participants whose youngest child was 7 years or younger.	71.4 percentile STANDARD_DEVIATION 29.2 • n=34 Participants • This measure was only collected on participants whose youngest child was 7 years or younger.	74.0 percentile STANDARD_DEVIATION 28.2 • n=81 Participants • This measure was only collected on participants whose youngest child was 7 years or younger.
Gainful Employment Yes	16 Participants n=87 Participants	8 Participants n=67 Participants	24 Participants n=154 Participants
Gainful Employment No	71 Participants n=87 Participants	59 Participants n=67 Participants	130 Participants n=154 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Participants who attended the 12 month follow-up assessment and completed the questions regarding mental health and substance abuse visits.

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Group Therapy n=68 Participants Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador	Standard of Care - Cognitive-Behavioral Group Therapy n=50 Participants Stress Management Class delivered in public housing sites by only a clinician
Total Outpatient Mental Health or Substance Abuse Visits	1.03 visits Standard Deviation 2.95	1.21 visits Standard Deviation 6.0

PRIMARY outcome

Timeframe: approximately 1 year

Population: Participants who attended the 12 month follow-up assessment.

The Center for Epidemiologic Studies Depression Scale (CES-D) is a screening test for depression and depressive disorder. The total score is a sum which ranges from 0-60. Higher scores indicate the presence of more symptomatology. Radloff, L.S. (1977) 'The CES-D scale: A self report depression scale for research in the general population'. Applied Psychological Measurement 1: 385-401.

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Group Therapy n=58 Participants Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador	Standard of Care - Cognitive-Behavioral Group Therapy n=47 Participants Stress Management Class delivered in public housing sites by only a clinician
Depressive and Anxiety Symptoms (CES-D)	13 units on a scale Interval 9.0 to 21.0	15 units on a scale Interval 9.0 to 24.0

PRIMARY outcome

Timeframe: 1 year

Population: This questionnaire was only administered to participants who had a child 8 years or older. Results are from participants who attended the 12 month follow-up assessment.

Parenting Stress Index Short Form by Richard R. Abidin (total score (36 questions) and 3 subscales (12 questions each) was used to describe parenting stress. Scores were created by summing the responses and then translated to percentiles for normative data (provided by the publisher). The total score represents an overall level of experienced parenting stress. A score 90 or above indicates experiencing clinically significant levels of stress. The subscale Parental Distress measures distress that the parent is experiencing related to parenting. High scores indicate more distress. The Parent-Child Dysfunctional Interaction subscale measures the parent's perception regarding a child meeting expectations and reinforcing interactions with the child. High scores indicate a parent-child bond that is threatened or not adequately established. The Difficult Child subscale looks at behavioral characteristics of children. Higher scores indicating difficulty managing the child's behavior.

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Group Therapy n=28 Participants Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador	Standard of Care - Cognitive-Behavioral Group Therapy n=19 Participants Stress Management Class delivered in public housing sites by only a clinician
Parenting Stress Parental Distress	65 percentile Interval 32.5 to 90.0	50 percentile Interval 1.0 to 70.0
Parenting Stress Parent-Child Dysfunctional Interaction	42.5 percentile Interval 7.5 to 85.0	20 percentile Interval 5.0 to 70.0
Parenting Stress Difficult Child	57.5 percentile Interval 15.0 to 80.0	10 percentile Interval 1.0 to 75.0
Parenting Stress Total	65 percentile Interval 25.0 to 85.0	15 percentile Interval 5.0 to 65.0

PRIMARY outcome

Timeframe: 1 year

Population: Participants who attended 12 month follow-up assessment.

Measure of subject's ability to obtain gainful employment

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Group Therapy n=58 Participants Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador	Standard of Care - Cognitive-Behavioral Group Therapy n=47 Participants Stress Management Class delivered in public housing sites by only a clinician
Gainful Employment Work 15 hours or more for pay	19 Participants	11 Participants
Gainful Employment Does not work 15 hours or more for pay	39 Participants	36 Participants

PRIMARY outcome

Timeframe: 1 series

Population: Since we are looking at implementation cost this measure isn't participant based, but calculated on what it would cost to run one series.

The implementation cost of providing a 8 session Stress Management (SM) Series (with 1 active series at a time) for both Standard of care with only a clinician, and also for a clinician and CMHA. The implementation costs include startup costs and on-going costs. On-going costs include staff salary, travel time, cell phones, space, and materials).

Outcome measures

Outcome measures
Measure	Cognitive-Behavioral Group Therapy n=1 1 SM series Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador	Standard of Care - Cognitive-Behavioral Group Therapy n=1 1 SM series Stress Management Class delivered in public housing sites by only a clinician
Implementation Cost	11350 American Dollars	10471 American Dollars

Adverse Events

Cognitive-Behavioral Group Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care - Cognitive-Behavioral Group Therapy

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. Megan Smith

Yale University

Phone: 2037648655

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place