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ADAPT

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT04298437

Conditions

Depression

Emotional Problem

Disruptive Behavior Disorder

Attention Deficit Hyperactivity Disorder

Conduct Disorder

Eligibility Criteria

Sex: All

Age: 6 - 10

Healthy Volunteers: Not accepted

Interventions

Addressing Depression and Positive Parenting Techniques (ADAPT) Program

Study Details

Brief summary:

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.

Conditions

Depression

Emotional Problem

Disruptive Behavior Disorder

Attention Deficit Hyperactivity Disorder

Conduct Disorder

Study ID

NCT04298437

Start date

May 1, 2022

Status verified date

Apr, 2024

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Sep 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 10

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Parent Group Treatment

Families who meet inclusion criteria will participate in the Parent Group Treatment (ADAPT Program).

no intervention: No Treatment

Families who do not meet inclusion criteria will not be invited to participate in the ADAPT Program.

Interventions

Addressing Depression and Positive Parenting Techniques (ADAPT) Program

The intervention is a targeted parenting intervention that has modules that help parents build emotion regulation skills, distress tolerance skills and alternative and more helpful ways of thinking about the causes of their child's EBD. The program also includes behavioral parent training skills building modules.

Primary outcome measure

  • Percentage of treatment sessions attended by parents measured using weekly attendance log [ Time Frame: 2 years ]
  • Treatment acceptability/satisfaction measured by weekly evaluation forms filled out by parents [ Time Frame: 2 years ]
  • Clinician adherence to ADAPT protocol measured by fidelity checks [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Brendan F Andrade, Ph.D.

416-535-8501brendan.andrade@camh.ca

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J1H4

Contacts

Brendan F Andrade, Ph.D.

416-535-8501brendan.andrade@camh.ca

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Apr 17, 2024

Last verified

Apr, 2024

Keywords

  • Depression
  • Emotional and Behavioural Difficulties
  • Disruptive Behaviour Disorders
  • Oppositional Defiant Disorder
  • Dialectical Behaviour Therapy
  • Parenting Skills
  • Behavioural Parenting Training
  • Conduct Disorder
  • Attention Deficit Hyperactivity Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2024-04-17. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.