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OpenTrials
Completed

NCT Number: NCT05145920

Encouraging Positive Parenting Habits Through Digital Media

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

D'Or Institute for Research

Rio de Janeiro, 22281-100, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HabitE (effective parenting habit) program (in Brazilian Portuguese)

Behavioral

Parents who enroll in the program will receive a series of 5 videos (~ 7 minutes each), 1 video at a time, generally every 3 days. Parents will also receive daily written texts, which include implementation tips and an assessment of a target (transition) behavior.

Primary outcomes

  1. Number of videos viewed

    Time frame: 1 month

    The number of videos viewed (minimum 0, maximum 5) to evaluate participant engagement.

  2. Percentage of completed daily ratings

    Time frame: 1 month

    The percentage of completed daily ratings (minimum 0, maximum 17). Parents are asked to provide daily ratings on the degree of success in implementing parenting strategies taught.

  3. Participant satisfaction

    Time frame: 1 month

    The parent-rated satisfaction regarding information presented in the videos. A rating completed after each video viewing using a 4-point scale. Averaged across the ratings completed for the videos viewed. (Minimum 0, maximum 4). Higher scores indicate greater satisfaction.

Secondary outcomes

  1. Parent-rated child's difficulties with daily transitions

    Time frame: 1 month

    The parent-rated child's difficulties with 9 common daily transitions. Ratings completed before and after the intervention using a 3-point scale. Averaged across the ratings completed for the 9 transitions. Higher scores indicate greater difficulties.

  2. Parent-rated child's impairment related to transition difficulties

    Time frame: 1 month

    The parent-rated level of impairment caused by transition difficulties (1 item). Ratings completed before and after the intervention using a 7 point scale. Higher scores indicate greater impairment.

  3. Proactive parenting

    Time frame: 1 month

    Multidimensional Assessment of Parenting Scale (MAPS) Proactive Parenting sub-scale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 6 items. Higher scores indicate more frequent use of proactive parenting strategies.

  4. Use of positive reinforcement

    Time frame: 1 month

    MAPS Positive Reinforcement sub-scale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 4 items. Higher scores indicate more frequent use of positive reinforcement strategies.

  5. Hostility toward child

    Time frame: 1 month

    MAPS Hostility sub-scale. Parent ratings completed before and after the intervention using a 5-point scale. Average across 7 items. Lower scores indicate less frequent use of hostile reactions during parent-child interactions.

Other outcomes

  1. ADHD symptoms

    Time frame: 1 month

    Strengths and Weakness of Attention-Deficit/Hyperactivity Disorder Symptoms and Normal Behavior Scale (SWAN) inattention and hyperactivity/impulsivity symptoms total. Parent ratings completed before and after the intervention using a 7-point scale. Averaged across 18 items. Higher scores indicate ADHD symptoms more frequently observed.

  2. ODD symptoms

    Time frame: 1 month

    SWAN oppositional/defiant symptoms total. Parent ratings completed before and after the intervention using a 7-point scale. Averaged across 8 items. Higher scores indicate ODD symptoms more frequently observed.

  3. Irritability

    Time frame: 1 month

    Affective Reactivity Index (ARI). Parent ratings completed before and after the intervention using a 3-point scale. Averaged across 6 items. Higher scores indicate irritability more frequently observed.

Sponsors and collaborators

Lead sponsor

D'Or Institute for Research and Education

Other

Collaborators

  • Federal University of Rio Grande do Sul
  • Okinawa Institute of Science and Technology Graduate University

Registry information

Acronym: Habite

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 6, 2021
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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