Comparing ADAPT Treatment with Incredible Years Parenting Program for depression / major depressive disorder
Official title: Optimizing Treatment for Depressed Parents of Children With Emotional and Behavioural Problems
Optimizing Treatment for Depressed Parents of Children With Emotional and Behavioural Problems (OPTED): A Randomized and Controlled Trial
Interventions
ADAPT Treatment
ADAPT is a 10-session virtual caregiver program (one individual engagement session and nine group sessions) that was developed with clinician and parent input. The initial engagement session is an individual meeting between the group facilitator and parent to build rapport and learn about the parent's unique challenges and parenting needs. Based on a motivational interviewing framework, this session is designed to gather information, discuss readiness for treatment and goals. The questions and tools used in this session help to build a collaborative understanding of unique child and parent needs that may be addressed through ADAPT and leave the parent with the hope that ADAPT can be helpful. The 9 virtual group treatment sessions that follow include modules to help parents understand the multiple potential contributions to their child's emotional/behavioral challenges, build their own emotion regulation skills, distress tolerance skills, and more helpful ways of thinking.
Incredible Years Parenting Program (IYPP)
The 12-session manualized treatment is considered a gold-standard treatment because it has shown efficacy in large-scale randomized and controlled trials and meta-analyses. Parents are helped to shift their children's emotional and behavioral difficulties through improved parental skills and competencies with behaviour management, and a parental problem-solving approach. IYPP will be delivered virtually.
Canadian Sites (1)
Ontario Institute for Studies in Education (OISE)
Toronto, Ontario, Canada
Eligibility Criteria
See who this study is looking for7 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +has a child aged 6-11 years with clinically elevated emotional and behavioural disorders (Abnormal Range, 93rd percentile) on the Total Difficulties Scale of the Strength and Difficulties Questionnaire (SDQ)
- +18 years of age or above
- +parent shows clinical elevations for mild-moderate depression on the Patient Health Questionnaire-8 (PHQ-8) (\>4 and \<15)
- +capacity to tolerate a virtual group context assessed by clinical interview
Exclusion
- −Parent shows active suicidal ideation, substance use disorder, or psychosis
- −they cannot communicate in English
- −child previously diagnosed with autism or an intellectual disability
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: ADAPT Treatment, Incredible Years Parenting Program (IYPP).
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 180 people.
The study is currently expected to finish around August 2030.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (pre-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →), post-treatment (12-weeks post-randomization), and 6-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Changes in child emotional and behavioral difficulties — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (pre-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →), post-treatment (12-weeks post-randomization), and 6-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07749521 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About ADAPT TreatmentBehavioural
ADAPT is a 10-session virtual caregiver program (one individual engagement session and nine group sessions) that was developed with clinician and parent input. The initial engagement session is an individual meeting between the group facilitator and parent to build rapport and learn about the parent's unique challenges and parenting needs. Based on a motivational interviewing framework, this session is designed to gather information, discuss readiness for treatment and goals. The questions and tools used in this session help to build a collaborative understanding of unique child and parent needs that may be addressed through ADAPT and leave the parent with the hope that ADAPT can be helpful. The 9 virtual group treatment sessions that follow include modules to help parents understand the multiple potential contributions to their child's emotional/behavioral challenges, build their own emotion regulation skills, distress tolerance skills, and more helpful ways of thinking.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About Incredible Years Parenting Program (IYPP)Behavioural
The 12-session manualized treatment is considered a gold-standard treatment because it has shown efficacy in large-scale randomized and controlled trials and meta-analyses. Parents are helped to shift their children's emotional and behavioral difficulties through improved parental skills and competencies with behaviour management, and a parental problem-solving approach. IYPP will be delivered virtually.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (pre-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →), post-treatment (12-weeks post-randomization), and 6-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →.
The study as a whole is currently expected to finish around 2030-08.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 180 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Standard Behavioral Parent Training (BPT) is often less effective for parents experiencing depression. As such, the Addressing Depression and Positive Parenting Techniques (ADAPT) intervention is a novel BPT tailored to address the unique emotional and cognitive needs of depressed parents to improve treatment outcomes. The objective of this study is to determine the efficacy of ADAPT in reducing child emotional and behavioral difficulties compared to the gold-standard Incredible Years Parenting Program (IYPP). This study is a 4-year, individually-randomized group treatment (IRGT), parallel-group trial. We aim to recruit 180 caregivers and their children (aged 6-11 years) seeking treatment for their child's emotional and behavioral difficulties from multiple mental health centres across Toronto, including but not limited to the University of Toronto, Centre for Addiction and Mental Health (CAMH), and Women's College Hospital (WCH). Participants will be asked to complete research measures: * before randomization * post-treatment * 6 months after the end of treatment Participants will be randomized to either the experimental ADAPT intervention - A 10-session virtual program (1 individual, 9 group) focused on emotion regulation, distress tolerance, and cognitive restructuring, or the control intervention: Incredible Years Parent Program (IYPP) - A 12-session gold-standard BPT delivered virtually.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.