CBT for Young Mothers (CBTYM)
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|ClinicalTrials.gov Identifier: NCT03329144|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2017
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Depression Emotion Regulation||Behavioral: Cognitive Behavioural Therapy||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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
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
|Welland, Ontario, Canada, L3B3W9|
|Principal Investigator:||Ryan J Van Lieshout, MD, PhD||McMaster University|