CBT for Young Mothers (CBTYM)

April 13, 2021 updated by: Ryan Van Lieshout, MD, PhD, McMaster University

Building Resilience in Young Mothers: A CBT-Based Curriculum

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Up to 50% of women who become parents during the teenage years suffer from mental disorders after the birth of their children. While they most commonly develop depression, anxiety problems and substance use disorders are also common, and in many cases they are comorbid. A significant proportion of these young women will also manifest impairing but sub-syndromal levels of symptoms. 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, as well as longer-term labour market outcomes.

Perinatal mental disorders are associated with significant suffering and high health care costs. Indeed, a single case of postpartum depression is estimated to cost $150,000, a figure that may be even higher in young mothers. Compounding these adverse effects is the fact that just 15% of women with young children and mental disorders receive evidence-based care, numbers that are almost certainly lower in young mothers given their well-known difficulties engaging in health care.

Getting these young women to engage in treatment can be a significant challenge, but given the substantial risks and costs associated with mental disorders in this group, as well as the effectiveness of preventive and treatment interventions (particularly the psychotherapies), it is important that innovative ways to engage and support adolescent mothers be developed. Since many will attend school either in a traditional or adapted setting, the educational system provides an ideal place to deliver interventions aimed at optimizing the mental health of teenage mothers.

The purpose of this pilot study is to develop and establish the feasibility of having public health nurses deliver a 9-session group cognitive behavioural therapy-based resilience curriculum within a school program for teenage mothers at the District School Board of Niagara. In addition to establishing the feasibility and acceptability of the curriculum, estimates of intervention effect and its variance will be generated to support a later large-scale study aimed at assessing its effectiveness.

CBT-based curriculum has been developed to help build resilience and optimize mood, anxiety, and emotion regulation in 15-24 year old women attending a supported school program in Niagara Region. Sixty women will be recruited and changes in depression, anxiety, emotion regulation, parenting, and behavioural problems in their children will be measured pre-group, immediately post-group, and 6 months later.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Welland, Ontario, Canada, L3B3W9
        • Strive Niagara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive Behavioural Therapy
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of delivering the group
Time Frame: 12 months
The feasibility of delivering the group will be assessed using simple counts of the number of women who agree to participate
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Beck Depression Inventory
Time Frame: 6 months
The Beck Depression Inventory is a 21-item scale that assesses the emotional, cognitive, and somatic symptoms of depression.
6 months
The Beck Anxiety Inventory
Time Frame: 6 months
The Beck Anxiety Inventory is a 21-item self-report scale that taps generalized anxiety disorder, the most common comorbidity of depression.
6 months
Difficulties in Emotion Regulation Scale
Time Frame: 6 months
The Difficulties in Emotion Regulation Scale is a 36-item measure of this construct validated in adolescents.
6 months
Adult-Adolescent Parenting Inventory
Time Frame: 6 months
The Adult-Adolescent Parenting Inventory-2 is a validated 40-item measure used to assess strengths and weaknesses in child rearing.
6 months
Strengths and Difficulties Questionnaire
Time Frame: 6 months
Impact on behavioural problems of women's other children will be assessed using the Strengths and Difficulties Questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Niagara Region Public Health
Strive Niagara

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ryan J Van Lieshout, MD, PhD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 3, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CBT YM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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