Video-based Family Therapy for Peripartum Depression in Home Visited Mothers

Peripartum Depression Clinical Trial

Official title:

Integrated Video-based Family Therapy for Peripartum Depression in Home Visited Mothers: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282448
• Other study ID #: 29987
• Secondary ID: UL1TR001086
• Status: Completed
• Phase: N/A
• Start date: May 26, 2017
• Est. completion date: June 13, 2018

Study information

• Verified date: June 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

1. Explore the feasibility of integrating the treatment model into two Federal HV Program sites in New Hampshire.

2. Test the acceptability of the treatment model among depressed adolescent mothers and their families.

3. Explore preliminary impacts of the treatment on maternal depressive symptoms and parenting attitudes, family emotion regulation, and family functioning at two months post-intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 13, 2018
• Est. primary completion date: June 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 25 Years

Eligibility

Home Visitor Inclusion Criteria:

1. Willingness to participate in the study;

2. Intention to remain in current job for at least 12 months; and

3. Fluency in English: The training, treatment model, implementation meetings, and supervision sessions will be carried out in English.

Family Inclusion Criteria:

1. Adolescent mothers, ages 13-25, in the first trimester of pregnancy through eighteen months postpartum;

2. Adolescent mothers with Edinburgh Postnatal Depression Scale scores of =8;

3. 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;

4. Fluency in English: The treatment will be carried out in English; and

5. 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

1. A current positive screen for problem alcohol use on the CAGE or TWEAK;

2. A current positive screen on the drug abuse items on the home visiting interview;

3. A current positive screen for domestic violence on the Relationship Assessment Tool;

4. Current hallucinations and/or delusions;

5. Current homicidal ideation;

6. Current suicidal ideation;

7. 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

8. Current self-injurious behavior (e.g., cutting arms on a weekly basis). Families with

9. Current Child Protection Service involvement;

10. Current family therapy service involvement; and/or

11. Current or previous Dialectical Behavior Therapy (DBT) treatment.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Peripartum Depression

Intervention

Behavioral:
• family therapy
The family-based intervention is informed by Dialectical Behavior Therapy Skills Training for Adolescents (Rathus & Miller, 2014).

Locations

Country	Name	City	State
United States	TLC Family Resource Center	Claremont	New Hampshire
United States	The Family Resource Center at Gorham	Gorham	New Hampshire

Sponsors (3)

Lead Sponsor	Collaborator
Fallon P. Cluxton-Keller	Dartmouth-Hitchcock Medical Center, National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal depressive symptoms	Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996)	5 months
Secondary	Therapist-family working alliance	Clinician rated, and maternal report and family member report.	2.5 months
Secondary	Family Satisfaction	Maternal report and family member report.	2.5 months
Secondary	Parenting attitudes	A reliable and valid self-report measure will be completed by mothers.	5 months
Secondary	Emotion regulation	A reliable and valid self-report measure will be completed by mothers and their family members.	5 months
Secondary	Family functioning	A reliable and valid self-report measure will be completed by mothers and their family members.	5 months