Perinatal DepressionNCT04741776

A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers

A study testing Resilience Enhancement Skills Training and Problem-Solving Individual Therapy in people with Perinatal Depression and Postpartum Depression, run by Dartmouth-Hitchcock Medical Center at 1 site 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

Who is it for?: Ages 15 years and older
Conditions the study is for: Perinatal Depression, Postpartum Depression, Family Conflict
What is being tested?: Resilience Enhancement Skills Training and Problem-Solving Individual Therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 166 participants
Where: 1 siteUnited States
Study dates: 22 Apr 2021to 14 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Mothers in any trimester of pregnancy through 18 months postpartum who are enrolled in home visiting at a participating agency;
Fluent in English;
Mother and her family member have at least an 8th grade education;
Mothers with Beck Depression Inventory-Second Edition scores of at least 20;
Perceived Hostility Survey-Adult raw scores of at least 16 for the adult mother and her adult family member; Perceived Hostility Survey-Child raw scores of at least 14 for the adolescent mother and her adolescent intimate partner; and
Consistent internet access on their cell phones, tablets, or computer equipped with a microphone and camera.

Who cannot join

Suicidal ideation in the mother and/or her family member;
Mothers with bipolar disorder symptoms;
Psychotic symptoms in the mother and/or her family member;
Mother is currently receiving individual therapy;
Family is currently receiving family therapy;
Mothers who have been taking an antidepressant for less than 2 months; and
Families with domestic violence.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth-Hitchcock Clinic
Lebanon, New Hampshire, 03756

Other trials in United States

About this study

Official title: A Pilot Randomized Trial of Video-based Family Therapy for Home Visited Mothers With Perinatal Depressive Symptoms

Depressed mothers (pregnant and post-delivery) make up a significant portion of Maternal, Infant, and Early Childhood Home Visiting (MIECHV) clients. Home visited mothers often experience family conflict that precipitates or worsens their depressive symptoms. This study uses an effectiveness-implementation hybrid type 1 design with a pilot randomized trial to test the feasibility, acceptability, tolerability, safety, and preliminary effectiveness of an innovative family therapy intervention that uses technology to bypass barriers to increase access to treatment for this vulnerable population.

Conditions: Perinatal Depression, Postpartum Depression, Family Conflict
Being tested: Resilience Enhancement Skills Training, Problem-Solving Individual Therapy
Medical subject headings: Depression, Postpartum

What participants receive

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

Resilience Enhancement Skills TrainingBehavioural
Family therapy
Problem-Solving Individual TherapyBehavioural
Individual therapy

Study groups in NCT04741776
Study group	Role	What they receive
Video-based family therapy	Experimental	Resilience Enhancement Skills Training (REST) Receives: Behavioral: Resilience Enhancement Skills Training
Standard of care	Active comparator	Video-based Problem Solving individual Therapy (V-PST) Receives: Behavioral: Problem-Solving Individual Therapy

What is being measured

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

Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up
Maternal depressive symptoms. The Beck Depression Inventory-Second Edition scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms).
Higher score indicates greater depressive symptoms.
Measured: Baseline and six month follow-up
Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up
Family conflict was measured using the Perceived Hostility Survey (Ages 18 +) and Perceived Hostility Survey (Ages 8-17). In both versions of the Perceived Hostility Survey, raw scores are converted to uncorrected T-scores. Scores one standard deviation or more below the mean (T ≤ 40) suggest low levels of perceived hostility and scores one standard deviation or more above the mean (T ≥ 60) suggest high levels of perceived hostility.
Measured: baseline and six month follow-up
Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up
Family cohesion was measured using the Multidimensional Scale of Perceived Social Support-Family with scores that range from 7-28. Higher scores indicate greater cohesion.
Measured: baseline and six month follow-up
Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up
Family cognitive reappraisal. Adult participants completed the Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Adult version) with scores that range from 6 (infrequent use of cognitive reappraisal) to 42 (frequent use of cognitive reappraisal). Adolescent participants completed the Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Children and Adolescents version) with scores that range from 6 (infrequent use of cognitive reappraisal) to 30 (frequent use of cognitive reappraisal).
Measured: Baseline and six month follow-up

Secondary outcomes (1)

Maternal School Enrollment/Job Attainment
Adapted item from ABCD study.
Measured: Change from baseline in maternal school enrollment/job attainment at 6 months

Timeline

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

22 Apr 202114 Nov 2023

First posted5 Feb 2021
Study start22 Apr 2021
Primary completion1 Jun 2023
Study completion14 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Perinatal DepressionStudies of the same condition, open and under way.
More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 166 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04741776
Sponsor's protocol ID: D21065
Other IDs: 1R34MH124951
Status last verified: Dec 2024
First submitted: 2 Feb 2021
Last updated: 8 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Cluxton-Keller F, Xie H, Hegel MT, Donnelly CL, Bruce ML. Preliminary Effectiveness of Family Therapy for Perinatal Depressive Symptoms: Results From a Pilot Randomized Trial. Fam Process. 2025 Jun;64(2):e70032. doi: 10.1111/famp.70032.
PubMed 40159324
Cluxton-Keller F, Hegel MT, Donnelly CL, Bruce ML. Video-Delivered Family Therapy for Perinatal Women With Depressive Symptoms and Family Conflict: Feasibility, Acceptability, Safety, and Tolerability Results From a Pilot Randomized Trial. JMIR Form Res. 2023 Nov 3;7:e51824. doi: 10.2196/51824.
PubMed 37921846
Cluxton-Keller F, Hegel MT. A Video-Delivered Family Therapeutic Intervention for Perinatal Women With Clinically Significant Depressive Symptoms and Family Conflict: Indicators of Feasibility and Acceptability. JMIR Form Res. 2022 Oct 4;6(10):e41697. doi: 10.2196/41697.
PubMed 36194458

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents
Anxiety, Depression
Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
Recruiting
Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications

All Perinatal Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Randomized Trial of Video-based Family Therapy for Home Visited Mothers With Perinatal Depressive Symptoms
ClinicalTrials.gov ID: NCT04741776
Acronym / sponsor ID: D21065
Conditions: Perinatal Depression, Postpartum Depression, Family Conflict
Study type: Interventional
Recruitment status: Completed
Enrolment: 166 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 22 Apr 2021 (actual)
Primary completion: 1 Jun 2023 (actual)
Study completion: 14 Nov 2023 (actual)
First posted: 5 Feb 2021 (actual)
Results: Posted 8 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Video-based family therapy	Experimental	Behavioral: Resilience Enhancement Skills TrainingResilience Enhancement Skills Training (REST)
Standard of care	Active comparator	Behavioral: Problem-Solving Individual TherapyVideo-based Problem Solving individual Therapy (V-PST)

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Mothers in any trimester of pregnancy through 18 months postpartum who are enrolled in home visiting at a participating agency;
Fluent in English;
Mother and her family member have at least an 8th grade education;
Mothers with Beck Depression Inventory-Second Edition scores of at least 20;
Perceived Hostility Survey-Adult raw scores of at least 16 for the adult mother and her adult family member; Perceived Hostility Survey-Child raw scores of at least 14 for the adolescent mother and her adolescent intimate partner; and

Key exclusion criteria (7 listed)

Suicidal ideation in the mother and/or her family member;
Mothers with bipolar disorder symptoms;
Psychotic symptoms in the mother and/or her family member;
Mother is currently receiving individual therapy;
Family is currently receiving family therapy;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Resilience Enhancement Skills TrainingFamily therapy	Behavioural	Video-based family therapy
Problem-Solving Individual TherapyIndividual therapy	Behavioural	Standard of care

Primary outcome

Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up
Time frame: Baseline and six month follow-up
Maternal depressive symptoms. The Beck Depression Inventory-Second Edition scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms). Higher score indicates greater depressive symptoms.
Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up
Time frame: baseline and six month follow-up
Family conflict was measured using the Perceived Hostility Survey (Ages 18 +) and Perceived Hostility Survey (Ages 8-17). In both versions of the Perceived Hostility Survey, raw scores are converted to uncorrected T-scores. Scores one standard deviation or more below the mean (T ≤ 40) suggest low levels of perceived hostility and scores one standard deviation or more above the mean (T ≥ 60) suggest high levels of perceived hostility.
Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up
Time frame: baseline and six month follow-up
Family cohesion was measured using the Multidimensional Scale of Perceived Social Support-Family with scores that range from 7-28. Higher scores indicate greater cohesion.
Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up
Time frame: Baseline and six month follow-up
Family cognitive reappraisal. Adult participants completed the Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Adult version) with scores that range from 6 (infrequent use of cognitive reappraisal) to 42 (frequent use of cognitive reappraisal). Adolescent participants completed the Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Children and Adolescents version) with scores that range from 6 (infrequent use of cognitive reappraisal) to 30 (frequent use of cognitive reappraisal).

1 secondary outcome

Maternal School Enrollment/Job Attainment
Time frame: Change from baseline in maternal school enrollment/job attainment at 6 months

Results and safety

Results posted to the registry on 8 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Video-based Family Therapy: Mothers	42	35
Video-based Family Therapy: Family Members	42	32
Standard of Care: Mothers	41	30
Standard of Care: Family Members	41	24

Primary outcome: Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up

Time frame: Baseline and six month follow-up. Mean (Standard Deviation). Unit: units on a scale (BDI-II)

Measure	Video-based Family Therapy: Mothers n = 38	Standard of Care: Mothers n = 37
Baseline	28.3 (5.8)	27.0 (6.1)
Six Month Follow-Up	6.9 (4.9)	13.2 (8.6)

Population analysed: All mothers who attended at least 1 session.

Primary outcome: Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up

Time frame: baseline and six month follow-up. Number. Unit: T-score

Measure	Video-based Family Therapy: Mothers n = 38	Video-based Family Therapy:Family Members n = 38	Standard of Care:Mothers n = 37	Standard of Care:Family Members n = 37
Baseline	58.7	60.1	60.1	58.7
Six month follow-up	44.2	46.3	52.9	52.9

Primary outcome: Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up

Time frame: baseline and six month follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	Video-based Family Therapy:Mothers n = 38	Video-based Family Therapy: Family Members n = 38	Standard of Care:Mothers n = 37	Standard of Care:Family Members n = 37
Baseline	20.6 (3.7)	20.9 (4.3)	19.7 (5.1)	20.2 (4.0)
Six month follow-up	23.7 (3.4)	24.0 (2.8)	19.3 (6.0)	20.9 (6.7)

Population analysed: All participants who completed at least one session. By design, mothers' family members did not participate in the Standard of Care intervention sessions.

Primary outcome: Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up

Time frame: Baseline and six month follow-up. Mean (Standard Deviation). Unit: units on a scale

Measure	Video-based Family Therapy:Adult Mothers n = 37	Video-based Family Therapy:Adolescent Mother n = 1	Video-based Family Therapy: Family Members n = 38	Standard of Care:Adult Mothers n = 37	Standard of Care:Family Members n = 37
Baseline	23.5 (5.7)	18.0 (0.0)	28.1 (7.7)	25.8 (5.7)	31.6 (5.8)
Six month follow-up	31.6 (5.8)	–	32.5 (6.8)	30.2 (5.4)	34.3 (5.8)

Population analysed: Participants who completed at least one session. By design, mothers' family members did not participate in Standard of Care intervention sessions.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Nine months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Video-based Family Therapy:Mothers	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Video-based Family Therapy: Family Members	0 of 42 (0%)	0 of 42 (0%)	0 of 42
Standard of Care: Mothers	0 of 41 (0%)	0 of 41 (0%)	1 of 41
Standard of Care: Family Members	0 of 41 (0%)	0 of 41 (0%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40159324Cluxton-Keller F, Xie H, Hegel MT, Donnelly CL, Bruce ML. Preliminary Effectiveness of Family Therapy for Perinatal Depressive Symptoms: Results From a Pilot Randomized Trial. Fam Process. 2025 Jun;64(2):e70032. doi: 10.1111/famp.70032.
Derived from this study: PubMed 37921846Cluxton-Keller F, Hegel MT, Donnelly CL, Bruce ML. Video-Delivered Family Therapy for Perinatal Women With Depressive Symptoms and Family Conflict: Feasibility, Acceptability, Safety, and Tolerability Results From a Pilot Randomized Trial. JMIR Form Res. 2023 Nov 3;7:e51824. doi: 10.2196/51824.
Derived from this study: PubMed 36194458Cluxton-Keller F, Hegel MT. A Video-Delivered Family Therapeutic Intervention for Perinatal Women With Clinically Significant Depressive Symptoms and Family Conflict: Indicators of Feasibility and Acceptability. JMIR Form Res. 2022 Oct 4;6(10):e41697. doi: 10.2196/41697.

Related trials for Perinatal Depression

Recruiting
Internet-Delivered Cognitive Behaviour Therapy for Depression and Anxiety in Perinatal Parents
Anxiety, Depression
Not yet recruiting
e-Perinatal Butterfly: An Embedded Study for Parents Experiencing Perinatal Loss
Depressive Symptoms, Perinatal Loss
Recruiting
Fathers and Babies (FAB) Research Study
Perinatal Mental Health, Fathers
Not yet recruiting
Inflammatory Pathways Modulated by Prenatal Mindfulness: A Route to Improve Maternal Child Emotional Well Being and Whole Person Health
Inflammation, Depression Disorder
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fallon Cluxton-Keller, Ph.D. principal investigator

Dartmouth-Hitchcock Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. 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 8 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up (time frame: Baseline and six month follow-up). The study lists 4 primary outcomes in all. 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 NCT04741776, which also lists 3 linked publications.

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 8 Jan 2025.