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Peripartum DepressionNCT03282448

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

A study testing family therapy in people with Peripartum Depression, run by Fallon P. Cluxton-Keller at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 13 to 25 years
Conditions the study is for
Peripartum Depression
What is being tested?
family therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesUnited States
Study dates
26 May 2017to 13 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 25 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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 locations and contacts

2 sites in 1 country.

United States2 sites

  • TLC Family Resource Center

    Claremont, New Hampshire, 03743

  • The Family Resource Center at Gorham

    Gorham, New Hampshire, 03581

Other trials in United States

About this study

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

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.

Read the 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.
Being tested
family therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • family therapyBehavioural

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

Study groups in NCT03282448
Study groupRoleWhat they receive
Family therapyExperimentalAdolescent mothers and their family members will receive a total of 10 weekly, 30-minute, video-based family therapy sessions.
Receives: Behavioral: family therapy
Historical comparison groupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal depressive symptoms

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

    Measured: 5 months

Secondary outcomes (5)

  1. Therapist-family working alliance

    Clinician rated, and maternal report and family member report.

    Measured: 2.5 months

  2. Family Satisfaction

    Maternal report and family member report.

    Measured: 2.5 months

  3. Parenting attitudes

    A reliable and valid self-report measure will be completed by mothers.

    Measured: 5 months

  4. Emotion regulation

    A reliable and valid self-report measure will be completed by mothers and their family members.

    Measured: 5 months

  5. Family functioning

    A reliable and valid self-report measure will be completed by mothers and their family members.

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2017
  2. Study start26 May 2017
  3. Primary completion13 Jun 2018
  4. Study completion13 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03282448
Sponsor's protocol ID
29987
Other IDs
UL1TR001086
Status last verified
Jun 2018
First submitted
12 Sep 2017
Last updated
19 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29158913

Questions about this trial

What is this clinical trial studying?

A study testing family therapy in people with Peripartum Depression, run by Fallon P. Cluxton-Keller at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal depressive symptoms (time frame: 5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03282448, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.

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