Clinical trial NCT03282448: 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
Overall status: COMPLETED
Phase: NA
Conditions: Peripartum Depression
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: Dartmouth-Hitchcock Medical Center
First posted: 2017-09-14
Enrollment: 26
Sex: ALL
Minimum age (years): 13
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Maternal depressive symptoms
timeFrame: 5 months
Secondary outcomes:
measure: Therapist-family working alliance
timeFrame: 2.5 months
measure: Family Satisfaction
timeFrame: 2.5 months
measure: Parenting attitudes
timeFrame: 5 months
measure: Emotion regulation
timeFrame: 5 months
measure: Family functioning
timeFrame: 5 months
Other outcomes:
Locations:
city: Claremont
country: United States
facility: TLC Family Resource Center
state: New Hampshire
city: Gorham
country: United States
facility: The Family Resource Center at Gorham
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Fallon P. Cluxton-Keller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth College
name: Craig L. Donnelly, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth College
name: Martha L. Bruce, Ph.D.
role: STUDY_CHAIR
References:
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.