Evaluating the Feasibility of Internet-delivered PCIT

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

Evaluating the Feasibility of Internet-delivered PCIT

Official Title

Evaluating the Feasibility of Internet-delivered Parent-Child Interaction Therapy

Brief Summary

      The present study is leveraging a randomized-controlled design to evaluate an Internet-based
      format for the delivery of Parent-Child Interaction Therapy (I-PCIT). Drawing on
      videoteleconferencing technology, this format affords real-time interactions for the
      provision of care traditionally delivered in person, regardless of a family's geographic
      proximity to a mental health facility. Moreover, drawing on technological innovation to
      deliver interventions directly to families in their natural settings may extend the
      ecological validity of PCIT, as treatment is delivered in the very context in which child
      problems occur. Families seeking treatment for early child disruptive behavior problems
      (N=40) are being randomly assigned to either receive Internet-delivered PCIT or clinic-based
      PCIT. Outcomes and feasibility/acceptability will be assessed across the treatment phase as
      well as at post-treatment and 6-month follow-up.
    

Detailed Description

      Establishing the feasibility of an Internet-based format for the delivery of evidence-based
      parent management is a critical step in the evaluation of technological innovations and their
      potential for advancing children's mental health care. Drawing on teleconferencing
      technology, such a format affords real-time interactions for the provision of care
      traditionally delivered in person, regardless of a family's geographic proximity to a mental
      health facility. Moreover, drawing on technological innovation to deliver interventions
      directly to families in their natural settings may extend the ecological validity of
      treatments, as treatments are delivered in the very contexts in which child problems occur.

      The objective of the present study is to develop an Internet-delivered Parent-Child
      Interaction Therapy (PCIT) protocol for preschoolers with Oppositional Defiant Disorder (ODD)
      or Conduct Disorder (CD) and to evaluate via randomized controlled trial (RCT) the
      feasibility and acceptability of enrolling, retaining, and treating children with I-PCIT
      relative to traditional PCIT. Phase I will involve development of an Internet-delivered PCIT
      (I-PCIT) protocol and treatment materials, including therapist treatment manual and online
      session handouts. Phase II will entail a case series: the PI will treat 5 consecutive
      preschool ODD/CD cases with I-PCIT, affording opportunity to further work out any
      difficulties with protocol or equipment. Phase III will entail testing the feasibility and
      acceptability of I-PCIT in a pilot RCT conducted with 40 children (ages 3-5) meeting for a
      Diagnostic and Statistical Manual (DSM-IV) principal diagnosis of ODD or CD and their
      parent(s) randomly assigned to I-PCIT or traditional PCIT. Parents will provide informed
      consent. All eligible families will receive evidence based treatment. Treatment will either
      be either in-clinic Parent-Child Interaction Therapy (PCIT) or Internet-delivered PCIT
      (I-PCIT). Formal evaluations will be conducted at baseline, post-treatment, and 6-month
      follow-up. Families can opt to participate in two optional psychophysiological components of
      the study (one involving behavioral tasks while parents are monitored via physiological
      equipment, and one involving play tasks while children are monitored via physiological
      equipment). All assessments will be conducted in the Department of Psychology at Florida
      International University (FIU), in the Center for Children and Families.
    


Study Type

Interventional


Primary Outcome

Clinical Global Impressions (CGI) Improvement Scale

Secondary Outcome

 Eyberg Child Behavior Inventory (ECBI)

Condition

Oppositional Defiant Disorder

Intervention

Parent-Child Interaction Therapy (PCIT)

Study Arms / Comparison Groups

 Internet-delivered treatment
Description:  This treatment arm entails Internet-Delivered PCIT (I-PCIT) remotely delivered in real time using videoconferencing. Families stream live parent-child interactions from their own home to a remote therapist who provides live bug-in-the-ear parent coaching via a parent-worn Bluetooth earpiece.

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

40

Start Date

April 4, 2011

Completion Date

December 31, 2016

Primary Completion Date

December 31, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Children (ages 3-5) meeting for DSM-IV principal Oppositional Defiant Disorder (ODD)
             or Conduct Disorder (CD), and at least 1 primary caretaker.

          -  Eyberg Child Behavior Inventory-Intensity Score in clinical range (i.e., >132).

          -  English-speaking (child & caretakers).

          -  Family home equipped w/ broadband connection and computer equipped with Pentium (or
             compatible) processor, 128 MB random-access memory (RAM), 200 Megabytes available of
             hard disk space, 16-bit color display adapter, universal series bus (USB) port.

        Exclusion Criteria:

          -  Behavior problems due to organic pathology or trauma,

          -  Child receiving medication to manage behavior difficulties,

          -  Presence of child emotional/behavior problem more impairing than ODD or CD,

          -  Parent or child score <75 standard score on intelligence quotient (IQ) screening,

          -  History of severe physical or mental impairments (e.g., mental retardation, deafness,
             blindness, pervasive developmental disorder) in child or participating caretaker(s).

          -  Child is a ward of the state
      

Gender

All

Ages

3 Years - 5 Years

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03260725

Organization ID

IRB-13-0451-CR01


Responsible Party

Sponsor

Study Sponsor

Florida International University

Collaborators

 Boston University

Study Sponsor

, , 


Verification Date

August 2017