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CBT for Young Mothers (CBTYM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03329144
Recruitment Status : Active, not recruiting
First Posted : November 1, 2017
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
Strive Niagara
Niagara Region Public Health
Information provided by (Responsible Party):
Ryan Van Lieshout, McMaster University

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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Emotion Regulation Behavioral: Cognitive Behavioural Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Building Resilience in Young Mothers: A CBT-Based Curriculum
Actual Study Start Date : January 3, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03329144


Locations
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Canada, Ontario
Strive Niagara
Welland, Ontario, Canada, L3B3W9
Sponsors and Collaborators
McMaster University
Strive Niagara
Niagara Region Public Health
Investigators
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Principal Investigator: Ryan J Van Lieshout, MD, PhD McMaster University
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Responsible Party: Ryan Van Lieshout, Assistant Professor, Department of Psychiatry and Behavioural Neurosciences, McMaster University
ClinicalTrials.gov Identifier: NCT03329144    
Other Study ID Numbers: CBT YM
First Posted: November 1, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ryan Van Lieshout, McMaster University:
Young mother
Depression
Anxiety
Resilience
Emotion regulation
Parenting
CBT
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms