Depression Clinical Trial
— ADAPTOfficial title:
Optimizing Treatment for Parents of Children With Emotional and Behavioural Problems (OPTED)
NCT number | NCT04298437 |
Other study ID # | 028/2019 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | December 1, 2024 |
Children with emotional and behavioural difficulties (EBD) experience disproportionate social, family and academic impairment and have between two to five times increased likelihood of developing an anxiety disorder, mood disorder or other severe mental illness in adolescence and adulthood. There is a close association between parental depression and the emergence and maintenance of childhood EBD that is likely bidirectional. Parents of children with EBD experience disproportionate stress, increasing their risk for depression; yet chronic and untreated parental depression is associated with the emergence of child EBD in the first place. Therefore, designing targeted and effective assessment and treatment for parents of children with EBD that take into account parents' depression is necessary. Of pressing concern, first-line Behavioral Parent Training (BPT) treatments for parents of children with EBD are not tailored to parent's mental health needs, which may be why upwards of 40 percent of parents and children treated in these programs fail to sufficiently benefit. Existing research highlights emotional and cognitive factors that may differentiate depressed parents from non-depressed parents that may be treatment targets to improve outcomes for depressed parents and children. The main aim of the proposed project is to evaluate the feasibility and acceptability of a novel targeted treatment for depressed parents of children with EBD, along with adherence to study protocol. The investigators will use the results of the pilot study to make key modifications to study procedures and the treatment itself to increase the success of a future randomized controlled trial (RCT) to test treatment efficacy. The investigators hypothesize that: 1. Recruitment will be feasible. 2. The intervention will be acceptable, and there will be a high rate of adherence to study protocol.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 1, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 10 Years |
Eligibility | Inclusion Criteria: - Parent is over the age of 18 years and has a child between the ages of 6 and 10; - Parent shows clinical elevations for Depression on the Patient Health Questionnaire (PHQ); - The child has clinically elevated Emotional Behavioural Difficulties (T-score of 65, Borderline range, 93rd percentile) on the Strength and Difficulties Questionnaire (Conduct Problem or Total Difficulties subscales); - The parent's has capacity to tolerate a group context. Exclusion Criteria: - Parent shows active suicidal ideation, substance use disorder, or psychosis; - Parent is not suitable for group treatment based on clinical interview; - Parent cannot communicate in English; - Child has a diagnosis of Autism Spectrum Disorder or Intellectual Disability (based on parent report). |
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Canada | Women's College Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health | Women's College Hospital |
Canada,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of treatment sessions attended by parents measured using weekly attendance log | Attendance Log - Clinicians leading the group sessions will track session attendance on a weekly basis along with documenting reasons for absenteeism. Treatment/recruitment will be considered feasible if greater than 70 percent of parents attend more than 70 percent of the sessions in each pilot group. | 2 years | |
Primary | Treatment acceptability/satisfaction measured by weekly evaluation forms filled out by parents | Weekly Evaluation Forms - Participants will be asked to share their opinions about session content and delivery on a weekly basis. The treatment will be considered acceptable if greater than 70 percent of all participants report adequate acceptability of the group treatment. | 2 years | |
Primary | Clinician adherence to ADAPT protocol measured by fidelity checks | Trained research staff will conduct weekly fidelity checks at the group treatment sessions to track clinician adherence to treatment content. The treatment will be considered acceptable if greater than 70 percent clinician adherence to the model is assessed by review of coded sessions checklists. | 2 years |
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