Clinical trial NCT05145920: Encouraging Positive Parenting Habits Through Digital Media
Official title: Encouraging Positive Parenting Habits Through Digital Media
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Parent Training
Treatment Access
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: Okinawa Institute of Science and Technology Graduate University
name: Federal University of Rio Grande do Sul
First posted: 2021-12-06
Enrollment: 27
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open, single-group trial
Primary purpose: TREATMENT

Brief summary: This study evaluates the feasibility and preliminary impacts of a new parenting program consisting of a series of educational videos, delivered via a popular texting platform. For this pilot project, the program content is focused on teaching parents strategies to better manage one of the commonly reported challenges that children face, a transition to a non-preferred activity. Parents with young children demonstrating behavior consistent with ADHD and experiencing difficulties with daily transition routines are invited to participate in the study.

Detailed description: This pilot study employs a pre-post, open trial design with the primary aim to investigate the feasibility of delivering parenting educational materials in a highly accessible format, i.e., a widely used texting platform. The training videos demonstrate the applications of antecedent- and reinforcement-based behavior management techniques in a specific situation and encourage parents to build positive parenting habits. The program usability and satisfaction will be assessed through ratings and answers to open-ended questions by participating parents. The study targets parents of children demonstrating symptoms of ADHD. These families frequently experience difficulties managing everyday routines at home, yet the access to psychosocial treatment is limited. The investigators expect parents to engage well in the program delivered via digital media. Based on the existing literature on the effectiveness of behavior parent training delivered in traditional in-person format, a moderate effect size is expected in the pre-post measures of parenting practices and the child target behavior for this study.

Eligibility criteria: Inclusion Criteria:

* Parents of children, aged 4-8, who demonstrate behavior symptoms consistent with ADHD symptoms, i.e., at least 4 inattention and/or 4 hyperactivity/impulsivity symptoms (parent-report). The number of symptoms is lower than the diagnostic threshold to include those with emerging problems. No diagnosis will be made or confirmed in the study. Children need to live with the participating parents at least 5 days per week every week.

Exclusion Criteria:

* Parents of children who have received other forms of pharmacological and/or non-pharmacological treatment in the past 3 months. These parents will be asked to wait to receive other forms of treatment until they complete the study participation.

Parents of children demonstrating symptoms consistent with Autism Spectrum Disorder, and those other difficulties (severe learning, mood and anxiety problems and environmental issues \[e.g., recent divorce\]) that would better explain the child's challenges transition routines.

Primary outcomes:
measure: Number of videos viewed
timeFrame: 1 month
measure: Percentage of completed daily ratings
timeFrame: 1 month
measure: Participant satisfaction
timeFrame: 1 month
Secondary outcomes:
measure: Parent-rated child's difficulties with daily transitions
timeFrame: 1 month
measure: Parent-rated child's impairment related to transition difficulties
timeFrame: 1 month
measure: Proactive parenting
timeFrame: 1 month
measure: Use of positive reinforcement
timeFrame: 1 month
measure: Hostility toward child
timeFrame: 1 month
Other outcomes:
measure: ADHD symptoms
timeFrame: 1 month
measure: ODD symptoms
timeFrame: 1 month
measure: Irritability
timeFrame: 1 month
Locations:
city: Rio de Janeiro
country: Brazil
facility: D'Or Institute for Research
Study officials:
affiliation: D'Or Institute for Research and Eduaction
name: Paulo E Mattos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: