- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05689736
Optimiser un programme parental basé sur Internet gratuit, diffusable et basé sur des preuves
The CDC's Essentials for Parenting Toddlers and Preschoolers program (EFP) is a free Internet resource with the potential to break down barriers to population-wide access to scientifically-based parenting interventions. EFP has considerable promise, but parental engagement, a major issue in the success of universal parenting interventions, remains a challenge. The objective of the proposed research is to optimize EFP by identifying engagement-focused intervention elements to add to EFP that enhance its effects on parenting skills.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The study is a longitudinal factorial optimization trial in a community sample of 800 parents with 1.5- to 3-year-old children. There are 4 experimental factors; each corresponds to the presence vs. absence of an engagement-focused intervention element. This experiment enables the estimation of the individual and combined effects of each element. The specific aims follow.
Aim 1: Optimize the effects of EFP on parenting skills by determining which combination of the four experimental engagement-focused intervention elements results in the greatest success of EFP, as reflected in increasing parent warmth and reducing corporal punishment, overreactive and lax discipline.
Aim 2: Determine the extent to which boosted meaningful parent engagement in EFP is the mechanism driving the effects of the four engagement-focused intervention elements on parenting skills, and which aspect(s) of engagement (e.g., content consumption; behavioral skills practice) are the key mediators that translate the effects of the four engagement-focused intervention elements into improved parenting.
Aim 3: Examine parent (e.g., change readiness; race) and child characteristics (e.g., externalizing behavior; sex) to determine if the optimal intervention package differs among subgroups. Cracking the code of providing parents with an intervention that they actually use, and that improves parenting, could have far-reaching effects (e.g., improving population-level child outcomes).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Maryland
-
Rockville, Maryland, États-Unis, 20850
- Westat, Inc.
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- 18- to 36-month-old child
- ≥18-year-old parent
- Internet access
- willingness to commit to intervention/assessment procedures
- proficiency in speaking and reading English
Exclusion Criteria:
- child older than 36 months
- parent younger than 18 years
- no access to internet
- not willing to commit to intervention/assessment procedures OR
- not proficient with speaking and reading English
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Motivational Enhancements + Simplification + Gamification + Low Engagement Nudge
Participants will receive the Core Essentials for Parenting (EFP) intervention and all additional engagement-focused intervention elements: motivational enhancements, simplification, gamification, and low engagement nudges. |
Motivational Enhancements (ME) will include three features:
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. Gamification will include four features:
SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Motivational Enhancements + Simplification + Gamification
Participants will receive the Core EFP intervention and motivational enhancement, simplification, and gamification intervention elements. |
Motivational Enhancements (ME) will include three features:
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. Gamification will include four features:
All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Motivational Enhancements + Simplification + Low Engagement Nudge
Participants will receive the Core EFP intervention and motivational enhancement, simplification, and low engagement nudges as intervention elements. |
Motivational Enhancements (ME) will include three features:
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Motivational Enhancements + Simplification
Participants will receive the Core EFP intervention and motivational enhancement and simplification as intervention elements. |
Motivational Enhancements (ME) will include three features:
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Motivational Enhancements + Gamification + Low Engagement Nudge
Participants will receive the Core EFP intervention and motivational enhancement, gamification, and low engagement nudge as intervention elements. |
Motivational Enhancements (ME) will include three features:
Gamification will include four features:
SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Motivational Enhancements + Gamification
Participants will receive the Core EFP intervention and motivational enhancement and gamification as intervention elements. |
Motivational Enhancements (ME) will include three features:
Gamification will include four features:
All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Motivational Enhancements + Low Engagement Nudge
Participants will receive the Core EFP intervention and motivational enhancement and low engagement nudge as intervention elements. |
Motivational Enhancements (ME) will include three features:
SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Motivational Enhancements
Participants will receive the Core EFP intervention and motivational enhancement as an additional intervention element. |
Motivational Enhancements (ME) will include three features:
All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Simplification + Gamification + Low Engagement Nudge
Participants will receive the Core EFP intervention and simplification, gamification, and low engagement nudge as additional intervention elements. |
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. Gamification will include four features:
SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Simplification + Gamification
Participants will receive the Core EFP intervention and simplification and gamification as additional intervention elements. |
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. Gamification will include four features:
All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Simplification + Low Engagement Nudge
Participants will receive the Core EFP intervention and simplification and low engagement nudge as intervention elements. |
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Simplification
Participants will receive the Core EFP intervention and simplification as an additional intervention element. |
We will follow recommendations of research on improving the readability of patient-directed text (e.g., fewer, shorter, less complex words, minimizing colons, semicolons, and decimal points). We will employ the Dale-Chall Readability (DCRI) score, which was developed for health education materials and, compared to other readability metrics, has higher correlations with comprehension. The target DCR score is 7 (8th grade reading level). We will avoid lower DCR scores because moderate levels of complexity enhance, attention, absorption, satisfaction, and ultimately engagement. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Gamification + Low Engagement Nudge
Participants will receive the Core EFP intervention and gamification and low engagement nudge as additional intervention elements. |
Gamification will include four features:
SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Gamification
Participants will view the Core EFP and will be exposed only to gamification as an additional intervention element. |
Gamification will include four features:
All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: Low Engagement Nudge
Participants will receive the Core EFP intervention and low engagement nudge as an additional intervention element. |
SMS text nudges will be sent to participants who have fallen behind in completing specific intervention tasks within a given time window; e.g., failing to log-in to the next module by a predetermined date, timed to program enrollment or in a prespecified number of days since completing the previous module. All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
|
Expérimental: EFP Only
Participants will receive the Core EFP intervention and not be exposed to any additional intervention elements. |
All parents will receive the Core intervention content, including text, demonstrations (videos and vignettes), and interactive activities (e.g., skill-building), and comprising five modules: Communicating with Your Child; (2) Giving Directions; (3) Creating Structure; (4) Using Discipline and Consequences; and (5) Using Time-out. The Core intervention will be augmented with more prescriptive behavioral skills practice exercises and SMS text nudges to remind participants to complete intervention modules. All conditions will be housed on Westat servers accessible through any device that can use the Internet, including computers, tablets, and smartphones. Westat has extensive technical capacities for web programming/hosting. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Parent Behavior Inventory, item average of Supportive/Engaged subscale
Délai: 6 months
|
Parental warmth (e.g., physical affection) will be measured by parent completing the 10-item self-report Supportive Engaged subscale of the Parent Behavior Inventory. |
6 months
|
|
Parent-Child Conflict Tactics Scale, item average of Corporal Punishment subscale
Délai: 6 months
|
Corporal punishment (noninjurious physical discipline, e.g., spanking) will be measured by parent completing the 6-item self-report corporal punishment subscale of the Parent-Child Conflict Tactics Scale |
6 months
|
|
Parenting Scale, item average of Overreactivity subscale
Délai: 6 months
|
Parents' use of harsh or otherwise overreactive discipline (i.e., angry discipline) will be measured by parent completing the 10-item self-report Overreactivity subscale of the Parenting Scale. |
6 months
|
|
Parenting Scale, item average of Laxness subscale
Délai: 6 months
|
Use of permissive or lax discipline (e.g., failure to enforce rules) will be measured by parent completing the 11-item self-report Laxness subscale of the Parenting Scale |
6 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kimberly Rhoades, Ph.D., New York University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 1R01HD101634 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
There is not a plan to make IPD available.
Informations sur les médicaments et les dispositifs, documents d'étude
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