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

F

Fallon P. Cluxton-Keller

Status

Completed

Conditions

Peripartum Depression

Treatments

Behavioral: family therapy

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03282448
UL1TR001086 (U.S. NIH Grant/Contract)
29987

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

All

Ages

13 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Family therapy
Experimental group
Description:
Adolescent mothers and their family members will receive a total of 10 weekly, 30-minute, video-based family therapy sessions.
Treatment:
Behavioral: family therapy
Historical comparison group
No Intervention group
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.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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