Video-based Family Therapy for Peripartum Depression in Home Visited Mothers
Primary Purpose
Peripartum Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
family therapy
Sponsored by
About this trial
This is an interventional prevention trial for Peripartum Depression
Eligibility Criteria
Home Visitor Inclusion Criteria:
- Willingness to participate in the study;
- Intention to remain in current job for at least 12 months; and
- Fluency in English: The training, treatment model, implementation meetings, and supervision sessions will be carried out in English.
Family Inclusion Criteria:
- Adolescent mothers, ages 13-25, in the first trimester of pregnancy through eighteen months postpartum;
- Adolescent mothers with Edinburgh Postnatal Depression Scale scores of ≥8;
- At least one of the adolescent mother's family members ("family member" is defined as a person she is biologically related to, or significant close others/partners with whom she is not biologically related) must be willing and available to participate in eight of the 10 video-based family therapy sessions;
- Fluency in English: The treatment will be carried out in English; and
- Consistent internet access (i.e., subscribe to an internet service provider and do not experience weekly disruptions in service) on a cell phone, tablet, or computer equipped with a camera and microphone.
Family Exclusion Criteria:
Adolescent mothers with
- A current positive screen for problem alcohol use on the CAGE or TWEAK;
- A current positive screen on the drug abuse items on the home visiting interview;
- A current positive screen for domestic violence on the Relationship Assessment Tool;
- Current hallucinations and/or delusions;
- Current homicidal ideation;
- Current suicidal ideation;
- Current severe major depressive episode as measured by the SCID-V Depression Module for those over age 18, or NIMH DISC-Y & DISC-P Mood Module for those under age 18; and/or
- Current self-injurious behavior (e.g., cutting arms on a weekly basis). Families with
- Current Child Protection Service involvement;
- Current family therapy service involvement; and/or
- Current or previous Dialectical Behavior Therapy (DBT) treatment.
Sites / Locations
- TLC Family Resource Center
- The Family Resource Center at Gorham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Family therapy
Historical comparison group
Arm Description
Adolescent mothers and their family members will receive a total of 10 weekly, 30-minute, video-based family therapy sessions.
The Edinburgh Postnatal Depression Scale scores of adolescent mothers in the intervention group will be compared to those of adolescent mothers, who were previously enrolled in the home visiting programs, at the same time points.
Outcomes
Primary Outcome Measures
Maternal depressive symptoms
Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
Secondary Outcome Measures
Therapist-family working alliance
Clinician rated, and maternal report and family member report.
Family Satisfaction
Maternal report and family member report.
Parenting attitudes
A reliable and valid self-report measure will be completed by mothers.
Emotion regulation
A reliable and valid self-report measure will be completed by mothers and their family members.
Family functioning
A reliable and valid self-report measure will be completed by mothers and their family members.
Full Information
NCT ID
NCT03282448
First Posted
September 12, 2017
Last Updated
June 16, 2018
Sponsor
Fallon P. Cluxton-Keller
Collaborators
National Center for Advancing Translational Sciences (NCATS), Dartmouth-Hitchcock Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03282448
Brief Title
Video-based Family Therapy for Peripartum Depression in Home Visited Mothers
Official Title
Integrated Video-based Family Therapy for Peripartum Depression in Home Visited Mothers: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 26, 2017 (Actual)
Primary Completion Date
June 13, 2018 (Actual)
Study Completion Date
June 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fallon P. Cluxton-Keller
Collaborators
National Center for Advancing Translational Sciences (NCATS), Dartmouth-Hitchcock Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study will explore the feasibility and acceptability of implementing a family-based treatment, using HIPAA-compliant video-based communication technology, for adolescents (pregnant and post-delivery) with peripartum depressive symptoms within the context of home visiting.
Detailed Description
The purpose of the pilot study is to partner with two Federal Maternal, Infant and Early Childhood Home Visiting (HV) Program sites to implement a family-based treatment for depression, using HIPAA-compliant video-based communication technology, in adolescent mothers (pregnant and post-delivery). This implementation-effectiveness hybrid trial includes depressed adolescent mothers and their adult family members.
It has three aims:
Explore the feasibility of integrating the treatment model into two Federal HV Program sites in New Hampshire.
Test the acceptability of the treatment model among depressed adolescent mothers and their families.
Explore preliminary impacts of the treatment on maternal depressive symptoms and parenting attitudes, family emotion regulation, and family functioning at two months post-intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripartum Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Family therapy
Arm Type
Experimental
Arm Description
Adolescent mothers and their family members will receive a total of 10 weekly, 30-minute, video-based family therapy sessions.
Arm Title
Historical comparison group
Arm Type
No Intervention
Arm Description
The Edinburgh Postnatal Depression Scale scores of adolescent mothers in the intervention group will be compared to those of adolescent mothers, who were previously enrolled in the home visiting programs, at the same time points.
Intervention Type
Behavioral
Intervention Name(s)
family therapy
Intervention Description
The family-based intervention is informed by Dialectical Behavior Therapy Skills Training for Adolescents (Rathus & Miller, 2014).
Primary Outcome Measure Information:
Title
Maternal depressive symptoms
Description
Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Therapist-family working alliance
Description
Clinician rated, and maternal report and family member report.
Time Frame
2.5 months
Title
Family Satisfaction
Description
Maternal report and family member report.
Time Frame
2.5 months
Title
Parenting attitudes
Description
A reliable and valid self-report measure will be completed by mothers.
Time Frame
5 months
Title
Emotion regulation
Description
A reliable and valid self-report measure will be completed by mothers and their family members.
Time Frame
5 months
Title
Family functioning
Description
A reliable and valid self-report measure will be completed by mothers and their family members.
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Home Visitor Inclusion Criteria:
Willingness to participate in the study;
Intention to remain in current job for at least 12 months; and
Fluency in English: The training, treatment model, implementation meetings, and supervision sessions will be carried out in English.
Family Inclusion Criteria:
Adolescent mothers, ages 13-25, in the first trimester of pregnancy through eighteen months postpartum;
Adolescent mothers with Edinburgh Postnatal Depression Scale scores of ≥8;
At least one of the adolescent mother's family members ("family member" is defined as a person she is biologically related to, or significant close others/partners with whom she is not biologically related) must be willing and available to participate in eight of the 10 video-based family therapy sessions;
Fluency in English: The treatment will be carried out in English; and
Consistent internet access (i.e., subscribe to an internet service provider and do not experience weekly disruptions in service) on a cell phone, tablet, or computer equipped with a camera and microphone.
Family Exclusion Criteria:
Adolescent mothers with
A current positive screen for problem alcohol use on the CAGE or TWEAK;
A current positive screen on the drug abuse items on the home visiting interview;
A current positive screen for domestic violence on the Relationship Assessment Tool;
Current hallucinations and/or delusions;
Current homicidal ideation;
Current suicidal ideation;
Current severe major depressive episode as measured by the SCID-V Depression Module for those over age 18, or NIMH DISC-Y & DISC-P Mood Module for those under age 18; and/or
Current self-injurious behavior (e.g., cutting arms on a weekly basis). Families with
Current Child Protection Service involvement;
Current family therapy service involvement; and/or
Current or previous Dialectical Behavior Therapy (DBT) treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fallon P. Cluxton-Keller, Ph.D.
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig L. Donnelly, M.D.
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martha L. Bruce, Ph.D.
Organizational Affiliation
Dartmouth College
Official's Role
Study Chair
Facility Information:
Facility Name
TLC Family Resource Center
City
Claremont
State/Province
New Hampshire
ZIP/Postal Code
03743
Country
United States
Facility Name
The Family Resource Center at Gorham
City
Gorham
State/Province
New Hampshire
ZIP/Postal Code
03581
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29158913
Citation
Cluxton-Keller F, Donnelly CL, Williams M, Buteau J, Stolte P, Monroe-Cassel M, Bruce ML. An implementation-effectiveness hybrid trial of video-based family therapy for peripartum depression in home visited mothers: a protocol for a pilot trial. Pilot Feasibility Stud. 2017 Nov 13;3:55. doi: 10.1186/s40814-017-0203-2. eCollection 2017.
Results Reference
derived
Learn more about this trial
Video-based Family Therapy for Peripartum Depression in Home Visited Mothers
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