証拠に基づいた、普及可能な、無料のインターネットベースの育児プログラムの最適化
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.
調査の概要
状態
条件
詳細な説明
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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Maryland
-
Rockville、Maryland、アメリカ、20850
- Westat, Inc.
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:階乗代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
|
実験的: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. |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Parent Behavior Inventory, item average of Supportive/Engaged subscale
時間枠: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
時間枠: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
時間枠: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
時間枠: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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Kimberly Rhoades, Ph.D.、New York University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1R01HD101634 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
There is not a plan to make IPD available.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。