Effectiveness of Parent-Child Interaction and Emotion Development Therapy in Treating Preschool Children With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of parent-child interaction therapy that includes
      an emotion development component in treating depression in preschool children.
    

Detailed description: 
      While growing up, children experience a range of emotions that change with development and
      environment. Although all young children experience sadness at times, a main characteristic
      of young children is their ability to experience joy and excitement in pleasurable childhood
      activities. When a child seems perpetually sad and no longer seems interested in previously
      enjoyed activities, the child may be showing signs of early onset depression. Children who
      are depressed are at increased risk for a wide range of social, psychological, physical, and
      achievement-related problems. Two previous studies have established the validity of early
      onset depressive syndrome in preschoolers, confirming the need for treatment during the
      preschool period. This study will specifically adapt parent child interaction therapy (PCIT),
      a proven effective treatment for preschool disruptive disorders, for use in preschoolers with
      depression and will include an additional component to focus on emotion development (ED). The
      study will evaluate the effectiveness of PCIT-ED in treating depression in preschool
      children.

      Participation in this two-stage study will last 16 weeks and will consist of initial
      assessments, 14 weeks of therapy, and a final assessment. Stage I will be used to assess the
      acceptability and reliability of the PCIT-ED manual, which will guide the treatment sessions.
      The protocol and assessment schedule will be the same for Stage I participants and Stage II
      participants assigned to PCIT-ED.

      The initial assessments will include both child and parent participants. Child participants
      will be asked to complete a series of tasks, which will include playing with games and toys,
      making selections based on feelings, completing stories started by a research assistant, and
      participating in other activities designed to be fun and exciting. Parents will be
      interviewed about their child's feelings, emotions, behaviors, and development and also about
      how their child gets along at home, in school, and with friends. Parents will also answer
      questions concerning their own mental health and drug history, parenting style, and moods.

      Participants will then be randomly assigned to receive PCIT-ED or Developmental Education
      Parenting Intervention (DEPI). Participants in both groups will attend fourteen 1-hour
      therapy sessions over a period of 14 weeks. For those assigned to PCIT-ED, most sessions will
      include both parent and child participants, but some will include parents only. During the
      parent-only sessions, the goals and procedures of upcoming therapy visits will be explained
      to parents. During sessions with both parent and child, participants will be taught positive
      parent-child interaction skills, ways to manage emotions, and relaxation techniques. After
      each therapy session, participants will be given homework that will involve practicing the
      skills learned in therapy sessions at home. At three points during the study, parents will
      also be asked to complete a brief questionnaire about their thoughts and feelings toward the
      therapy process. The therapy sessions for the participants assigned to DEPI will provide
      basic education in all areas of preschool development, with emphasis on social and emotional
      development. The initial assessments will be repeated for all participants at the end of
      treatment.
    

Intervention name(s): Parent Child Interaction Therapy-Emotion Development (PCIT-ED); Developmental Education Parenting Intervention (DEPI)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): PCIT-ED includes fourteen 1-hour therapy sessions over 14 weeks. Sessions will focus on positive parent-child interactions skills, ways to manage emotions, and relaxation techniques.; DEPI includes 14 weekly, 1-hour education sessions covering a range of child development and parenting topics. Classes are in a small group format and will emphasize emotional and social development.
Other intervention name(s): PCIT-ED; DEPI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Preschool Onset Major Depressive Disorder; Preschool Depression; Emotion Development; Parent Child Interaction