Encouraging Positive Parenting Habits Through Digital Media

ADHD Clinical Trial

— Habite  

Official title:

Encouraging Positive Parenting Habits Through Digital Media

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05145920
• Other study ID #: 50214221.6.0000.5249
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: October 24, 2022

Study information

• Verified date: April 2023
• Source: D'Or Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• HabitE (effective parenting habit) program (in Brazilian Portuguese)
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.

Locations

Country	Name	City	State
Brazil	D'Or Institute for Research	Rio de Janeiro

Sponsors (3)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education	Federal University of Rio Grande do Sul, Okinawa Institute of Science and Technology Graduate University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	ADHD symptoms	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.	1 month
Other	ODD symptoms	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.	1 month
Other	Irritability	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.	1 month
Primary	Number of videos viewed	The number of videos viewed (minimum 0, maximum 5) to evaluate participant engagement.	1 month
Primary	Percentage of completed daily ratings	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.	1 month
Primary	Participant satisfaction	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.	1 month
Secondary	Parent-rated child's difficulties with daily transitions	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.	1 month
Secondary	Parent-rated child's impairment related to transition difficulties	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.	1 month
Secondary	Proactive parenting	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.	1 month
Secondary	Use of positive reinforcement	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.	1 month
Secondary	Hostility toward child	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.	1 month