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

NCT ID: NCT03282448

Last Updated: 2018-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-26

Study Completion Date

2018-06-13

Brief Summary

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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

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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.

Conditions

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Peripartum Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Family therapy

Adolescent mothers and their family members will receive a total of 10 weekly, 30-minute, video-based family therapy sessions.

Group Type EXPERIMENTAL

family therapy

Intervention Type BEHAVIORAL

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

Historical comparison group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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family therapy

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.


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.

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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role collaborator

Fallon P. Cluxton-Keller

OTHER

Sponsor Role lead

Responsible Party

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Fallon P. Cluxton-Keller

Assistant Professor Psychiatry

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fallon P. Cluxton-Keller, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Craig L. Donnelly, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Martha L. Bruce, Ph.D.

Role: STUDY_CHAIR

Dartmouth College

Locations

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TLC Family Resource Center

Claremont, New Hampshire, United States

Site Status

The Family Resource Center at Gorham

Gorham, New Hampshire, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 29158913 (View on PubMed)

Other Identifiers

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UL1TR001086

Identifier Type: NIH

Identifier Source: secondary_id

View Link

29987

Identifier Type: -

Identifier Source: org_study_id

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