Addressing Depression and Positive Parenting Techniques (ADAPT)

Related Clinical Trial
Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy With the Help of Artificial Intelligence Symptoms and Mechanisms of Child Psychiatric Disorders Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances Randomized Feasibility Trial of Mind My Mind Metabolic Effects of Antipsychotics in Children Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to Collaborative Care for Children’s Mental Health Problems Manville Moves: an Exercise Intervention for Behavioral Regulation Among Children With Behavioral Health Challenges Addressing Depression and Positive Parenting Techniques (ADAPT) Child and Family Outcomes and Consumer Satisfaction for Online vs Staff-Delivered Parenting Intervention Phone-Delivered Psychological Intervention (t-CETA) for Mental Health Problems in 8-17 Year-Old Syrian Refugee Children Mindful Parenting and Parent Training Program Study Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder Enhanced Support for Behavioral Barriers to Learning: An Evaluation of the SCHOOL STARS Program Medication Strategies for Treating Aggressive Behavior in Youth With Attention Deficit Hyperactivity Disorder Correlating Real and Virtual World Behavioral Fluctuations in Adolescence Evaluating an Online Parenting Support System Disseminated by Pediatric Practices Study of Cognition and Control in Youths Treatment of Conduct Problems and Depression The Effectiveness of Parent-Child Interaction Therapy (PCIT) School-Based Mental Health Services for Urban Children A Study of the Safety and Effectiveness of Risperidone for the Treatment of Conduct Disorder and Other Disruptive Behavior Disorders in Children Ages 5 to 12 With Mild, Moderate, or Borderline Mental Retardation Investigation of Psychophysiological Response to Aversive Stimuli Over Time With Omega-3 Investigation of Psychophysiological Correlation of Aggression and Response to Aversive Stimuli Behavioral Sleep Intervention in Children With Disruptive Behaviors Arousal-Biofeedback for the Treatment of Aggressive Behavior in Children and Adolescents Strongest Families Ontario (Formerly the Family Help Program) On-line Treatment for Conduct Problems Behavioral Treatment for Children With Conduct Problems and Callous-Unemotional Traits A Study of the Safety and Effectiveness of Risperidone Versus Placebo for the Treatment of Conduct Disorder in Children With Mild, Moderate, or Borderline Mental Retardation Supplements and Social Skills Intervention Study Evaluating the Feasibility of Internet-delivered PCIT Resources to Enhance the Adjustment of Children (REACH) Ziprasidone for Severe Conduct and Other Disruptive Behavior Disorders Treatment of Children With Peer Related Aggressive Behavior (ScouT) Prevention of Oppositional Defiant and Conduct Disorders in Preschool Children Preschool First Step to Success: An Efficacy Replication Study Home Based Treatment for Drug Use in Early Adolescents Methylphenidate vs. Risperidone for the Treatment of Children and Adolescents With ADHD and Disruptive Disorders Mindfulness-based Program for Children With Disruptive Behavior Disorder Guided Self-Help for Parents of Children With Externalizing Problem Behavior Randomized Controlled Trial of Comet Via the Internet or in Group Format. An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD). Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany Comparison of Two Psychosocial Therapies for Treating Children With Oppositional-Defiant Disorder Evaluation of Regulation Focused Psychotherapy for Children Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD Parent Training and Emotion Coaching for Children With Limited Prosocial Emotions Multi-Family Group Therapy for Reducing Behavioral Difficulties in Youth Treatment of Children With Peer Related Aggressive Behavior

Brief Title

Addressing Depression and Positive Parenting Techniques (ADAPT)

Official Title

Optimizing Treatment for Parents of Children With Emotional and Behavioural Problems (OPTED)

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.
    

Detailed Description

      Study Rationale:

      Developmental theories underscore the reciprocal nature of parent-child interactions and the
      importance of adult teaching and modeling to enable the development of children's emotion
      regulation, frustration tolerance and behavioural regulation skills. Similarly, these models
      are bidirectional in that children's skills develop along with, and influence parental
      cognitions, emotional functioning and the manner in which parent's impose expectations and
      respond to children's behaviour. Indeed, adult-child transactions can serve to increase or
      decrease a child and parent's frustration and arousal, fuel response biases in the child and
      parent, and lead to adaptive or maladaptive parent and child behaviour. Much literature has
      documented the close association between parental depression and the emergence and
      maintenance of childhood EBD. From transactional and biopsychosocial perspectives, it has
      been suggested that depression negatively impacts a parent's ability to regulate their own
      emotions and cognitions, and subsequently positively attend to their child. As such, parental
      depression may indirectly contribute to a cycle of behavioural escalation on the part of the
      child to get their needs met. This is not to suggest that parental depression causes
      childhood EBD; however, shared genetic and environmental factors may contribute to challenges
      with parent and child co-regulation of emotion, elevated irritability, unhelpful thinking
      patterns, and perpetuation of a problematic cycle of interactions. Transactional theory
      suggests that the "fit" between parental emotional functioning, cognition and behaviour with
      child emotional and behavioural functioning may be of primary importance, rather than
      indicating any one ideal parenting approach as is suggested by standard BPT. The
      transactional model suggests that compatibility between adult and child characteristics and
      behaviour will produce optimal outcomes. Indeed, the goal of BPT is to help parents develop
      skills that meet the needs of children with EBD. Current programs may not have sufficient
      therapeutic components that match the emotional, cognitive and behavioural needs of parents
      with depression suggesting that alternative and targeted models may be indicated for these
      parents.

      Research Questions:

      The aim of the research is to determine the feasibility of novel assessment and treatment for
      parents with depression that builds parent's functional cognitions, emotion regulation,
      parenting competencies and skills (Addressing Depression and Positive Parenting Techniques
      (ADAPT)).

        1. To determine the feasibility of recruitment

             1. What is the rate of eligible parents in each of the pilot recruitment sites and
                overall?

             2. What is parents' level of readiness to engage in parenting treatment?

             3. What is the recruitment rate in each setting and what are reasons for
                non-participation?

        2. To determine feasibility and acceptability of a novel treatment.

             1. What are participant (and clinician) views of the intervention?

             2. What is the rate of completion of the intervention and reasons for discontinuation?

             3. What is the average number of groups attended?

        3. Adherence to study protocol

             1. What is the level of clinician adherence to the ADAPT protocol?

             2. What is the follow-up rate for outcome data collection, including measures of
                parental depression, parenting stress, parenting skills, parent-child interactions
                and child EBD?

      The investigators hypothesize that recruitment will be feasible, that the intervention will
      be acceptable, and that there will be a high rate of adherence to the study protocol.

      Significance of the Study:

      Although parents are clearly critically important to the success of BPT, very little research
      has focused on understanding key parental factors that may be important to assess or on the
      effectiveness of BPT tailored to parents with depression. Existing research has primarily
      focused on logistical barriers to treatment such as socioeconomic status or child-factors,
      such as the severity or type of EBD, that may moderate or mediate BPT outcomes. Important
      parental factors associated with depression, such as parental cognitions, and parental
      emotional and behavioural regulation skills, have largely been ignored when designing novel
      interventions. Systematically understanding differences between parents with and without
      depression on these key factors and the feasibility of novel treatment will identify avenues
      for treatment innovation.

      Study Design

      Clinic-referred parents with depression who have children with EBD will be recruited from the
      Mood and Anxiety Service (MAAS) Clinic at the Centre for Addiction and Mental Health (CAMH)
      and the Women's Mental Health Program at Women's College Hospital (WCH). Non-depressed
      parents of children with EBD will be recruited from the Child, Youth and Emerging Adult
      Program (CYEAP) at CAMH. The target sample size is 80 parents (40 depressed, 40
      non-depressed) and their children with EBD. Participants will be recruited over two years. A
      multi-modal measurement approach incorporating subjective and objective measures and tasks
      will be used.

      Parent and child psychopathology and treatment outcome will be measured by widely used and
      validated parent and child-completed interviews, questionnaires and recorded tasks. Measures
      were chosen based on their sound psychometric properties. Additionally, many of the
      child-based measures have been used by the PI in ongoing clinical research projects and
      parent measures used in the MAAS. As such, the feasibility of completing these measures in
      the clinical setting has been confirmed.
    


Study Type

Interventional


Primary Outcome

Percentage of treatment sessions attended by parents measured using weekly attendance log


Condition

Depression

Intervention

Addressing Depression and Positive Parenting Techniques (ADAPT) Program

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

80

Start Date

December 1, 2021

Completion Date

December 1, 2024

Primary Completion Date

December 1, 2023

Eligibility Criteria

        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).
      

Gender

All

Ages

6 Years - 10 Years

Accepts Healthy Volunteers

No

Contacts

Brendan F Andrade, Ph.D., 416-535-8501, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04298437

Organization ID

028/2019


Responsible Party

Sponsor

Study Sponsor

Centre for Addiction and Mental Health

Collaborators

 Women's College Hospital

Study Sponsor

Brendan F Andrade, Ph.D., Principal Investigator, Centre for Addiction and Mental Health


Verification Date

July 2021