New Haven MOMS Partnership

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01665872
• Collaborator: Department of Health and Human Services (U.S. Fed), Office of Research on Women's Health (ORWH) (NIH)
• Enrollment: 154
• Location: 1
• Arms: 2
• Actual Duration (Months): 61
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

Phase II of the MOMS Partnership aims to:

1. conduct a needs assessment of the mental health of mothers residing in New Haven, CT;

2. provide on-site group intervention services (randomized by housing community) to improve signs/symptoms of depression/stress/trauma among mothers living onsite.

Condition or Disease	Intervention/Treatment	Phase
Depression; Stress	Behavioral: Cognitive-Behavioral Group Therapy	N/A

Detailed Description

The purpose of this project is to expand and enhance the New Haven Mental health Outreach for Mothers (MOMs) Coalition beyond pregnancy and depression to include a broader definition of mental illness (depressive, anxiety, and substance use disorders), and a larger target population (low-income, racially and ethnically diverse, pregnant and parenting women) in the City of New Haven. Through this expansion, the Coalition will bring together the community of women, their families and advocates, healthcare providers, policy and agency leaders, and academics, to inform the development and conduct of public health approaches around the mental health of low-income, racially and ethnically diverse, pregnant and parenting women.

The specific goals of this Phase I proposal are:

1. To conduct a community-led needs assessment on the mental health of low-income, ethnically and racially diverse pregnant and parenting women in the City of New Haven.

2. To provide randomized intervention services to improve signs/symptoms of depression/stress/trauma among mothers living in public housing in New Haven, CT

Study Design

• Study Type: Interventional
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: New Haven Mental Health Outreach for MotherS (MOMS) Partnership
• Actual Study Start Date: May 1, 2012
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Behavioral: Cognitive-Behavioral Group Therapy; CBT Group; Other Names: CBT Group
Active Comparator: 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.	Behavioral: Cognitive-Behavioral Group Therapy; CBT Group; Other Names: CBT Group

Outcome Measures

Primary Outcome Measures

1. Total Outpatient Mental Health or Substance Abuse Visits [1 year]

   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.

2. Depressive and Anxiety Symptoms (CES-D) [approximately 1 year]

   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.

3. Parenting Stress [1 year]

   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.

4. Gainful Employment [1 year]

   Measure of subject's ability to obtain gainful employment

5. Implementation Cost [1 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• CES-D score >=16

• Child under the age of 18 (participant must be a mother)

• Resident of public housing authority complex in New Haven, CT or an affiliated Section 8 recipient

Exclusion Criteria:

• Positive for psychosis

• Active suicidal ideation

• Non-English or Spanish speakers

• Unable to provide informed consent

• Unwilling to accept randomization

• Moving within the intervention & follow-up period

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale School of Medicine	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Yale University
• Department of Health and Human Services
• Office of Research on Women's Health (ORWH)

Investigators

• Principal Investigator: Megan V Smith, MPH, DrPH, Yale School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01665872
• Other Study ID Numbers: 1010007484; 5CCEWH1110210501
• First Posted: Aug 15, 2012
• Last Update Posted: Feb 10, 2020
• Last Verified: Feb 1, 2020

• Keywords provided by Yale University: Mothers; Depression; Stress; Trauma; Public Housing
• Additional relevant MeSH terms: Depression

Study Results

Participant Flow

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

Arm/Group Title	Cognitive-Behavioral Group Therapy	Standard of Care - Cognitive-Behavioral Group Therapy
Arm/Group Description	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	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
Period Title: Screening
STARTED	172	172
COMPLETED	172	172
NOT COMPLETED	0	0
Period Title: Screening
STARTED	87	67
COMPLETED	72	50
NOT COMPLETED	15	17
Period Title: Screening
STARTED	72	50
COMPLETED	66	49
NOT COMPLETED	6	1
Period Title: Screening
STARTED	72	50
COMPLETED	58	47
NOT COMPLETED	14	3

Baseline Characteristics

Arm/Group Title	Cognitive-Behavioral Group Therapy	Standard of Care - Cognitive-Behavioral Group Therapy	Total
Arm/Group Description	Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador	Stress Management Class delivered in public housing sites by only a clinician	Total of all reporting groups
Overall Participants	87	67	154
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	87 100%	67 100%	154 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.1 (11.0)	39.2 (11.2)	38.6 (11.1)
Sex: Female, Male (Count of Participants)
Female	87 100%	67 100%	154 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
White, Non-Hispanic	3 3.4%	5 7.5%	8 5.2%
Black, Non-Hispanic	68 78.2%	52 77.6%	120 77.9%
White, Hispanic	11 12.6%	6 9%	17 11%
Black, Hispanic	2 2.3%	3 4.5%	5 3.2%
Other	3 3.4%	1 1.5%	4 2.6%
Region of Enrollment (participants) [Number]
United States	87 100%	67 100%	154 100%
CES-D total score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	28.2 (9.3)	30.4 (9.8)	29.2 (9.6)
Total outpatient mental health or substance abuse visits (visits) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [visits]	4.5 (16.3)	2.1 (10.0)	3.4 (13.9)
Parenting Stress Index Short Form: Parental Distress Percentile (percentile) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentile]	82.4 (21.2)	73.9 (28.5)	78.9 (24.7)
Parenting Stress Index: Parent-Child Dysfunctional Interaction Percentile (percentile) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentile]	61.4 (30.0)	59.6 (33.3)	60.7 (31.2)
Parenting Stress Index: Difficult Child Percentile (percentile) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentile]	62.0 (33.6)	58.9 (31.4)	60.7 (32.5)
Parenting Stress Index Short Form: Total Score Percentile (percentile) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentile]	75.8 (27.6)	71.4 (29.2)	74.0 (28.2)
Gainful Employment (Count of Participants)
Yes	16 18.4%	8 11.9%	24 15.6%
No	71 81.6%	59 88.1%	130 84.4%

Outcome Measures

1. Primary Outcome

Title	Total Outpatient Mental Health or Substance Abuse Visits
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Cognitive-Behavioral Group Therapy	Standard of Care - Cognitive-Behavioral Group Therapy
Arm/Group Description	Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador	Stress Management Class delivered in public housing sites by only a clinician
Measure Participants	68	50
Mean (Standard Deviation) [visits]	1.03 (2.95)	1.21 (6.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive-Behavioral Group Therapy, Standard of Care - Cognitive-Behavioral Group Therapy
	Comments
	Type of Statistical Test	Equivalence
	Comments	A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.
Statistical Test of Hypothesis	p-Value	0.172
	Comments
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Depressive and Anxiety Symptoms (CES-D)
Description	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.
Time Frame	approximately 1 year

Outcome Measure Data

Analysis Population Description

Participants who attended the 12 month follow-up assessment.

Arm/Group Title	Cognitive-Behavioral Group Therapy	Standard of Care - Cognitive-Behavioral Group Therapy
Arm/Group Description	Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador	Stress Management Class delivered in public housing sites by only a clinician
Measure Participants	58	47
Median (Inter-Quartile Range) [units on a scale]	13	15

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive-Behavioral Group Therapy, Standard of Care - Cognitive-Behavioral Group Therapy
	Comments	Are CES-D scores at 12 months different between groups?
	Type of Statistical Test	Equivalence
	Comments	A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.
Statistical Test of Hypothesis	p-Value	0.5337
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

3. Primary Outcome

Title	Parenting Stress
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Cognitive-Behavioral Group Therapy	Standard of Care - Cognitive-Behavioral Group Therapy
Arm/Group Description	Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador	Stress Management Class delivered in public housing sites by only a clinician
Measure Participants	28	19
Parental Distress	65	50
Parent-Child Dysfunctional Interaction	42.5	20
Difficult Child	57.5	10
Total	65	15

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive-Behavioral Group Therapy, Standard of Care - Cognitive-Behavioral Group Therapy
	Comments
	Type of Statistical Test	Equivalence
	Comments	A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.
Statistical Test of Hypothesis	p-Value	0.0920
	Comments	This test looks at a difference in Parental Distress at the 12 month follow-up between groups.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cognitive-Behavioral Group Therapy, Standard of Care - Cognitive-Behavioral Group Therapy
	Comments
	Type of Statistical Test	Equivalence
	Comments	A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.
Statistical Test of Hypothesis	p-Value	0.3352
	Comments	This test looks at a difference in Parent-Child Dysfunctional Interaction at the 12 month follow-up between groups.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cognitive-Behavioral Group Therapy, Standard of Care - Cognitive-Behavioral Group Therapy
	Comments
	Type of Statistical Test	Equivalence
	Comments	A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.
Statistical Test of Hypothesis	p-Value	0.0404
	Comments	This test looks at a difference in Difficult Child at the 12 month follow-up between groups.
	Method	Wilcoxon (Mann-Whitney)
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cognitive-Behavioral Group Therapy, Standard of Care - Cognitive-Behavioral Group Therapy
	Comments
	Type of Statistical Test	Equivalence
	Comments	A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.
Statistical Test of Hypothesis	p-Value	0.0915
	Comments	This test looks at a difference in PSI total score (percentile) at the 12 month follow-up between groups.
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Primary Outcome

Title	Gainful Employment
Description	Measure of subject's ability to obtain gainful employment
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

Participants who attended 12 month follow-up assessment.

Arm/Group Title	Cognitive-Behavioral Group Therapy	Standard of Care - Cognitive-Behavioral Group Therapy
Arm/Group Description	Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador	Stress Management Class delivered in public housing sites by only a clinician
Measure Participants	58	47
Work 15 hours or more for pay	19 21.8%	11 16.4%
Does not work 15 hours or more for pay	39 44.8%	36 53.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cognitive-Behavioral Group Therapy, Standard of Care - Cognitive-Behavioral Group Therapy
	Comments
	Type of Statistical Test	Equivalence
	Comments	Chi-square was used with a p-value of 0.05 to determine if the difference was statistically greater than 0.
Statistical Test of Hypothesis	p-Value	0.2914
	Comments
	Method	Chi-squared
	Comments

5. Primary Outcome

Title	Implementation Cost
Description	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).
Time Frame	1 series

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Cognitive-Behavioral Group Therapy	Standard of Care - Cognitive-Behavioral Group Therapy
Arm/Group Description	Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador	Stress Management Class delivered in public housing sites by only a clinician
Measure Participants	NA	NA
Measure 1 SM series	1	1
Number [American Dollars]	11350	10471

Adverse Events

Time Frame	Adverse event data was monitored for all enrolled participants beginning at enrollment. This continued through engagement in the intervention and all follow-up (1 year post intervention).
Adverse Event Reporting Description	The definition does not differ. Methods for reporting adverse events: any serious, unanticipated and related adverse events or unanticipated problems involving risks to subjects or others will be reported in writing within 48 hours to the HIC and any appropriate funding and regulatory agencies. Fellow investigators and study personnel will be informed through regular study meetings and study sponsors will be informed within 5 days of the event becoming known to the principal investigator.
Arm/Group Title	Cognitive-Behavioral Group Therapy		Standard of Care - Cognitive-Behavioral Group Therapy
Arm/Group Description	Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador		Stress Management Class delivered in public housing sites by only a clinician
All Cause Mortality
	Cognitive-Behavioral Group Therapy		Standard of Care - Cognitive-Behavioral Group Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/67 (0%)
Serious Adverse Events
	Cognitive-Behavioral Group Therapy		Standard of Care - Cognitive-Behavioral Group Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/67 (0%)
Other (Not Including Serious) Adverse Events
	Cognitive-Behavioral Group Therapy		Standard of Care - Cognitive-Behavioral Group Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/87 (0%)		0/67 (0%)

Limitations/Caveats

Limitations include subjects self-selected to participate and uncertainty in the representativeness of our sample to all residents of public housing. The ICER could not be calculated due to similarity in CES-D scores in both groups.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.