NCT03329144

Brief Summary

Approximately 1 in 4 adolescent mothers will develop depression after delivering a child, though some studies suggest that as many as 53% will develop postpartum depression. A frequent accompanying symptom is emotion dysregulation which not only adversely affects their mental well-being, but jeopardizes their parenting and their child's health. Unfortunately significant barriers exist for young mothers, preventing access to treatment. This study will pilot the feasibility of having public health nurses deliver this 9-session program within a curriculum for teen mothers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 3, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

April 14, 2021

Status Verified

April 1, 2021

Enrollment Period

2.2 years

First QC Date

October 30, 2017

Last Update Submit

April 13, 2021

Conditions

AnxietyDepressionEmotion Regulation

Keywords

Young motherDepressionAnxietyResilienceEmotion regulationParentingCBT

Outcome Measures

Primary Outcomes (1)

  • Feasibility of delivering the group

    The feasibility of delivering the group will be assessed using simple counts of the number of women who agree to participate

    12 months

Secondary Outcomes (5)

  • The Beck Depression Inventory

    6 months

  • The Beck Anxiety Inventory

    6 months

  • Difficulties in Emotion Regulation Scale

    6 months

  • Adult-Adolescent Parenting Inventory

    6 months

  • Strengths and Difficulties Questionnaire

    6 months

Study Arms (1)

Cognitive Behavioural Therapy

EXPERIMENTAL

The women in this arm will receive a 9-week CBT-based curriculum delivered by Public Health Nurses to help build resilience and optimize mood, anxiety, and emotion regulation while attending a supported school program in Niagara Region.

Behavioral: Cognitive Behavioural Therapy

Interventions

Cognitive Behavioural TherapyBEHAVIORAL

The transdiagnostic CBT-based curriculum is based on the extensive clinical experience of the research team with young women and those struggling with perinatal mental disorders. The team also has significant expertise delivering CBT for depression and anxiety (including perinatal variants) in groups. The manual was developed by the research team and is based on the state-of-the-art in resilience and CBT interventions in adolescents and young adults (e.g., the Penn Resiliency Program (60), Treatment for Adolescent Depression Study (61)). After it was developed, it was subjected to further scrutiny by public health nurses and STRIVE staff, who have extensive experience working with young mothers.

Cognitive Behavioural Therapy

Eligibility Criteria

Age15 Years - 24 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • As this is a study of young mothers, women who are 15-24 years of age, speak English, and have a child under the age of 5 will be recruited.

You may not qualify if:

  • Only women aged 15-24 years who have a child under the age of five will be eligible. Women must be enrolled in the Strive Niagara program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strive Niagara

Welland, Ontario, L3B3W9, Canada

Location

MeSH Terms

Conditions

Anxiety DisordersDepressionEmotional Regulation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorSelf-ControlSocial Behavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ryan J Van Lieshout, MD, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Psychiatry and Behavioural Neurosciences

Study Record Dates

First Submitted

October 30, 2017

First Posted

November 1, 2017

Study Start

January 3, 2018

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

April 14, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)