NCT03282448

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 26, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2018

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

1 year

First QC Date

September 12, 2017

Last Update Submit

June 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maternal depressive symptoms

    Depressive symptoms will be measured using the Beck Depression Inventory (BDI-II; Beck, Steer, \& Brown, 1996)

    5 months

Secondary Outcomes (5)

  • Therapist-family working alliance

    2.5 months

  • Family Satisfaction

    2.5 months

  • Parenting attitudes

    5 months

  • Emotion regulation

    5 months

  • Family functioning

    5 months

Study Arms (2)

Family therapy

EXPERIMENTAL

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

Behavioral: family therapy

Historical comparison group

NO INTERVENTION

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.

Interventions

family therapyBEHAVIORAL

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

Family therapy

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

TLC Family Resource Center

Claremont, New Hampshire, 03743, United States

Location

The Family Resource Center at Gorham

Gorham, New Hampshire, 03581, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Family Therapy

Intervention Hierarchy (Ancestors)

Psychotherapy, GroupSocioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Fallon P. Cluxton-Keller, Ph.D.

    Dartmouth College

    PRINCIPAL INVESTIGATOR
  • Craig L. Donnelly, M.D.

    Dartmouth College

    PRINCIPAL INVESTIGATOR
  • Martha L. Bruce, Ph.D.

    Dartmouth College

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor Psychiatry

Study Record Dates

First Submitted

September 12, 2017

First Posted

September 14, 2017

Study Start

May 26, 2017

Primary Completion

June 13, 2018

Study Completion

June 13, 2018

Last Updated

June 19, 2018

Record last verified: 2018-06

Locations